Page 53

Book 136, Special section, 308 Ngo Government Gazette, 18 December, 2020
Announcement of the Ministry of Public Health
Regarding the provision of Medical Devices by risk level B.E. 2560

To control and supervise Medical Devices to be effective and consistent with regulation of medical
devices at ASEAN and international levels; therefore, it is deemed appropriate to classify the medical
devices or Medical Devices according to the level of risk that may cause danger to human health or
human life or impact on public health to ensure the safe use of medical tools and protect customers in
the appropriate way.
By virtue of the provisions of Section 5, paragraph 5 of the Medical Device Act B.E. 2551 and Section 6
(1) of the Medical Device Act B.E. 2551 which was amended by the Medical Device Act (Issue 2) B.E.
2560, Minister of Public Health, by the recommendation of The Medical Device Board issued the
announcement as follows.
Article 1 Medical Devices shall be organized into 2 groups as follows
(1) In vitro diagnostic medical device and (2) Medical devices that are not physicians for medical
examination Vinci Non-in vitro diagnostic medical device).
Article 2. Group medical devices or medical devices for in-vitro diagnostics (In vitro diagnostic medical
device) according to the risk level of individuals and public health from low to high as follows.
(1) Medical device in category 1 means a medical device that has a low risk to a person and public
health;
(2) Medical device type 2 means a medical device with moderate risk per person or low risk to public
health;
(3) Medical device type 3 means a medical device with a high risk to an individual or moderate risk to
public health;
(4) Medical devices in category 4 mean medical devices that pose a high risk to the person and public
health
The classification of medical tools for in-vitro diagnostics according to the risk level according to Article 1
shall be in accordance with document No. 1 attached to the announcement.

Article 3. Group medical devices or medical devices that are not medical devices for Non-in vitro
diagnostic medical device according to risk level Which may occur from low to high as follows
(1) Medical device type 1 means a medical device that has low risk;
(2) Medical device Category 2 means a medical device with medium to low level of risk;
(3) Medical device Category 3 means a medical device with medium to high risk;
(4) Medical device Category 4 means a medical device with a high risk Classification of medical devices
that are not medical devices for in-vitro diagnostics.
According to the risk level, shall be in accordance with document number 2 attached to this
announcement
Article 4 In case of problems with medical device classification, the Secretary-General shall have the
power to make a decision on the classification of medical devices.
Article 5 The arrangement of medical devices by risk level according to this notification Have control
measures for medical device groups or medical devices as follows.
(A) a group of medical devices or medical devices that a manufacturer or importer has to obtain, such as
a medical device under Article 2 (4) or Article 3 (4).
(B) Medical device groups or medical devices that the manufacturer or importer must declare in detail
including Medical devices under Article 2 (2) (3) or Article 3 (2) (3).
(C) a group of medical devices or medical devices that a manufacturer or importer must register,
including medical devices under Article 2 (1) or Article 3 (1).
Medical device groups or medical devices that need to be licensed detailed report or to notify the
Minister as to the advice of the Medical Device Committee in the case of consumer protection, the
Minister shall, with the advice of the Committee, the medical device shall have the power to announce
and specify a group of medical devices or medical devices that are different from the first paragraph.
Article 6 This Notification shall come into force from the day following the date of its publication in the
Government Gazette.

Announced on November 14, 2019

Anutin Charnwaree
Minister of Public Health

Attachment 1
Medical device classification for in-vitro diagnostics based on risk levels Attached to the announcement
of the Ministry of Public Health, regarding the organization of medical devices by risk level B.E. 2560.
Classification of medical devices for in-vitro diagnostics based on risk levels is determined by factors
affecting the risk level, such as the purpose, use and indications of the medical device. Which is
determined by the product owner's expertise of the user of the medical device Importance and impact
of data from medical devices towards individuals and public health.
1. In this document
"Medical device" means medical devices for humans, excluding animals.
"In Vitro Diagnostic (IVD) medical devices" means reagent, reagent product, calibrator, control material,
kit, instrument , apparatus or equipment, analysis system or any other object Whether used by alone,
together, or together with other medical devices owned by Products intended for examination, sent
from the human body, including blood and organs donating to provide information.
(1) physiological conditions, pathology, or congenital disability.
(2) Consider the safety and compatibility of contents of the person who has the opportunity to receive
an organ or (3) to monitor the treatment Including specimen storage containers
"Instrument" means the device or tool that the product owner intended to use Is a medical device for in
vitro diagnostics.
"Reagent" means a chemical composition Biological or immunology, solution or preparation, and the
preparation that the product owner intends to use as a medical device for in-vitro diagnostics.
"IVD medical device for self-testing" means the medical device for in-vitro diagnostics that the product
owner Intended for use by general people.
"Specimen receptacle" means a medical device for In vitro diagnostics Whether vacuum or not Which
the product owner specifically aimed at For the collection of specimens directly from the primary
containment.
"Product owner" means an individual or a juristic person that
(1) sell medical devices under one's own name or under the design trademark
Trade names or other names or other marks owned or controlled by and
(2) responsible for the design, production, assembly, operation (process) of the show
Labeling, packing, or assignment of such actions according to the objectives Whether done by oneself or
under the assignment of that person
"Lay person" means a person who has not received training in a related field or field

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"Examination" (examination) means various processes to find the value of property or characteristics.
NOTICES:
Inspection for substances in biological samples In general, it is called test, assay, or analysis.
"Near patient testing" means the tests performed externally Laboratory Medical personnel that do not
need to be a professional practitioner in general do near the patient or on the side of the patient. This
can also be called a test at the point of care for patients.

"Self-testing" means testing conducted by ordinary people.

"Transmissible agent" means a substance that can transmit or transmit to a person who causes a
communicable disease or infectious diseases.
"Transmission" means the transmission of pathogens to persons.
2. Criteria for classification of medical devices for in vitro diagnostics based on risk level Principle 1:
Medical devices for in vitro diagnostics with the following objectives:
Medical devices in Category 4
• Medical devices intended to detect communicable diseases or signs of exposure that causes
bloodborne diseases, blood components, blood products, cells, membranes, or organs in order to assess
the suitability of blood transfusions or implants, or
• Medical devices intended to detect communicable diseases or signs of exposure Communicable
diseases that cause life-threatening conditions, incurable diseases that are at risk of high spread
Principle and reason Since it is a medical device for in-vitro diagnostics intended to ensure the safety of
blood and blood components for giving or transfusion of blood or cell transplantation Tissue and organs
Most of the test results are important factors for consideration regarding donations or Product use
Serious illness arising from the giving or transfer of blood or cell transplantation, tissue and organs,
causing death or long-term disability cannot be treated or needing treatment. Therefore, a precise
diagnosis is important in reducing the effects of public health.
Examples of tests for HIV, HCV, HBV, HTLV testing. These criteria apply to primary screening tests.
Confirmation analysis And additional analysis
Principle 2: Medical devices for in vitro diagnostics intended to test for blood types or the type of tissue
to ensure compatibility with blood immune reactions Blood components, tissues, cells, or organs For
giving or transfusion of blood or implants classified as a medical device type 3.
Medical devices for in vitro diagnostics for blood type tests, ABO system (A (ABO1), B (ABO2), AB
(ABO3)] rhesus system [RH1 (D). , RH2 (C), RH3 (E),
 
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RH4 (c), RH5 (e)] Kell system [Kel1 (K)] Kidd system [JK1 (Jka), JK2 (Jkb)] and Duffy system ) (FY1 (Fya),
FY2 (Fyb)] is a Category 4 of the medical device.

Principles and reasons

As it is a medical device that is highly risky to the person, if the result of the examination is incorrect, the
patient will be fatal. Therefore, it is classified as a Category 4 medical device. This rule is classified
Medical devices for in vitro diagnostics to test for blood types are 2 types, which are type 3 medical
devices or type 4 medical devices, depending on the characteristics of the blood group antigens that
medical devices can detect. And the importance of blood group antigens in giving or transfusion of
blood
Example: HLA (Duffy system) (other Duffy system) Except in the category 4 medical devices), which are
classified as medical devices of type 3.
Principle 3: Medical devices for in-vitro diagnostics intended for using as follows shall be classified as a
medical device type 3.
• To detect what causes sexually transmitted diseases or signs of exposure to what causes it Sexually
transmitted diseases (such as Chlamydia trachomatis, Neisseria gonorrhoeae).
• In the detection of pathogens in short waxes (cerebrospinal fluid) or blood that is at risk Because it is a
culture that has limitations in culture (such as Neisseria meningitidis or Cryptococcus neoformans).
• In the detection of pathogens with high risk If the test results are incorrect Patient or baby in the
womb shall deceased or become severely disabled (such as diagnostic tests Cytomegalovirus (CMV),
Chlamydia pneumoniae, Methycillin Resistant Staphylococcus aureus.
• In prenatal screening for immunization to identify communicable diseases (such as immune tests for
Rubella or Toxoplasmosis).
• In the examination of the status of infectious diseases or immune conditions If the test results are
incorrect There will be a risk leading to treatment decisions that put patients in life-threatening
situations (such as Enteroviruses, CMV and Herpes simplex virus (HSV) testing in organ transplant
patients).
• In screening to select patients for treatment and specific treatment or stage of disease or diagnosing
cancer (such as personalized medication).

NOTICES:

Medical devices for in vitro diagnostics above require additional diagnostic tests and Follow-up before
making a treatment decision is considered to be a medical device of category 2 under criteria 6
• In human genetic testing (such as Huntington’s Disease, Cystic Fibrosis)
• To monitor drug levels Biological substances or components If the test results are incorrect There is a
risk that leads to treatment decisions that put patients in a life-threatening situation (such as Cardiac
markers, cyclosporine, prothrombin time testing).
• In the treatment of life-threatening infections (such as HCV viral load, HIV viral load and HIV and HCV
geno- and subtyping)
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• Screening for congenital abnormalities in the fetus (such as Spina Bifida or Down Syndrome).
Principle and reason due to this medical device for in-vitro diagnostic High risk to the person or
moderate risk to public health If the test results are wrong, the patient will be in situations that are life
threatening or causing significant negative effects Medical instruments for diagnosis outside the body,
this group will only provide one or more important information for an accurate diagnosis. And may be at
high risk to people due to the stress and anxiety caused by the information received and the potential
follow-up process.
Principle 4: Medical devices for in vitro diagnostics intended for testing by itself is classified as a type 3
medical device. In the medical device, the test results do not indicate a critical medical condition or the
initial examination results that must be monitored by appropriate laboratory tests, classified as Category
2 medical devices for in-vitro diagnostics intended for checking blood gas and blood glucose by testing
near the patient, classified as a Category 3 medical device, while other medical devices for in-vitro
diagnostics intended for testing near the patient classified according to medical device classification
guidelines.
Principles and reasons
Due to users of medical devices for in-vitro diagnostics, this group Is a person who does not have
technical expertise, so labeling and usage instructions Therefore it is important to the accuracy of the
test results.
Examples of medical devices for external diagnosis for the body intended for testing Type 3: Blood
glucose monitoring kit
Examples of medical devices for external diagnosis for the body intended for testing By self. Type 2 is a
pregnancy test. Fertility test kit Urine test kit
Principle 5: Medical devices for in-vitro diagnostic as follows Classified as a medical device type 1
• take medicines or other substances of a particular type that the product owner intended for use in the
process or In vitro diagnostic procedures that are specific to the examination
• Tools intended by the product owner for use in external diagnostic procedures.
body
• Specimen receptacles

NOTICES

Products used in general laboratories that are not manufactured, sold or displayed for diagnostic
purposes. Outside the body Not considered a medical device for in vitro diagnostics.
Principle and reason Because it is a medical device for in-vitro diagnostics that has low risk to individuals
and there is no risk or low risk to public health.
Examples of media for isolation/classification (except dry powder type Which is not a medical device For
complete in vitro diagnostics), a collection of tools for identification of the type of bacteria, wash
solutions, tools and urine collection containers.

NOTICES
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(1) Assessing the performance of software or tools Which has specific requirements in the assessment
Should be carried out at the same time as evaluating the test kit
(2) The use of tools and testing methods together is to prevent the tools from being evaluated
separately. Although the tools are classified as medical devices of type 1
Principle 6: Medical devices for in-vitro diagnostics, other than those specified In criteria 1-5, classified
as medical devices of category 2

Principles and reasons

Due to this medical device for in-vitro diagnostic Moderate risk to individuals If the test results are
incorrect shall not cause death or disability, severe, or significant negative effects on treatment or acute
harm to patients. The results of examinations in medical devices are one of many factors used in
treatment. If the test results are just one data While other information such as signs and symptoms or
clinical data That the doctor may use as a treatment guide Medical devices are classified as type 2
medical devices. There should be other controls suitable to verify the results of the test. Category 2
medical devices, including medical devices for in vitro diagnostics that have low risk for public health
due to the use to detect what causes infectious diseases that are not easily spread in the population.
Examples of H. pylori blood gas and physiological indicators are such as hormones, vitamins, enzymes,
metabolic indicators, specific IgE analysis and celiac disease markers.
Principle 7: Medical devices for in-vitro diagnosis that are not controlled, quantitative or qualitative
values, classified as a medical device type 2.

Principles and reasons

Medical devices for in-vitro diagnostics that are controlled by the user, determine quantitative or
qualitative values, not the product owner.
3. In the event that a medical device may be classified in more than one category according to the above
rules To classify medical devices is the type that has the highest risk.
4. In the event that the medical device is designed to be used in conjunction with other medical devices
as well to classify used medical devices separately, and consider classifying each medical device item.
5. In the case of medical devices with more than one purpose to classify medical devices according to
the purpose of use with the highest risk.
Attachment 2

Classification of medical devices that are not medical devices for in-vitro diagnostics According to the
risk level attached to the announcement of the Ministry of Public Health regarding the risk level, B.E.
2560.
Classification of medical devices that are not medical devices for in-vitro diagnostic based The risk is
determined by factors that affect the risk, such as the level of penetration into the body, body length,
and the use of biological effects.
1. In this document
"Medical device" means medical devices for humans, excluding animals. "Active medical device" means
any medical device in which the operation requires an electric power source or other sources of energy
that are not directly generated by the body.
Human or gravity can work by converting these energy, but medical devices intended to transmit
energy, substances, or other elements between powerful medical devices and patients without having
any significant changes, it is not considered a powerful medical device. The stand alone software (which
is classified as a medical device in the definition of a medical device) is considered a medical device.
"Medical device with therapeutic power" (active therapeutic device) means a medical device that has
any strength Whether used alone or in combination with other medical devices to support or support,
modify, replace or restore the function or biological structure With the aim of treating or alleviating
illness, injury or disability.
"Active device intended for diagnosis" means any medical device that has any power, whether used
alone or in conjunction with other medical devices, to provide information for diagnostic examination or
to support the treatment of physiological conditions, health conditions, illness or congenital disability.
"Implantable medical device" means any medical device, including partially or wholly absorbed, which is
intended to penetrate into the entire human body or replace the epithelium or skin of the eye by
surgery to allow the medical device to remain in the body after the act according to the method of use
of the medical device. Any medical device intended to be partially inserted into the human body
through surgery and intended to remain in the body for at least 30 days is considered to be a medical
device used for implantation in the body.
"Medical device that invades into the body" (invasive medical device) means medical device that
penetrates into the body; regardless of all or just some through the opening of the body or through the
skin.
"Life supporting or life sustaining" means a medical device that is necessary or providing information
that is necessary to return to normalcy or perform bodily functions which is important for life.
"Medical devices penetrate into the body through surgical methods" (surgically invasive medical device)
means a medical device that is inserted into the body through the skin. By surgical methods in some or
all. Medical devices other than those described above and used to implant into the body by not passing
through the openings of the body naturally It is a medical device that penetrates into the body through
surgical methods.
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"Reusable surgical instrument" means a device intended for use in surgery by cutting, drilling, sawing,
scraping, shaving, grasping, pulling the nest, or other surgical methods without connection. With
powerful medical devices And the owner of the product intended Reuse it after going through a cleaning
process or sterilizing it with appropriate methods.
"Product owner" means an individual or a juristic person that
(1) sell medical devices under one's own name or under the design trademark
Trade names or other names or other marks owned or controlled by and
(2) responsible for the design, production, assembly, operation (process) of the show
Labeling, packing, or assignment of such actions according to the objectives Whether done by oneself or
under the assignment of that person
"Body orifice" means the natural opening of the body, including the skin of the eyeball or a permanent
artificial opening such as a stoma or permanent tracheotomy.
"Central circulatory system" in this document means that the main internal blood vessels are
(1) pulmonary artery
(2) ascending aorta
(3) coronary artery
(4) common carotid artery
(5) External carotid artery
(6) Internal carotid artery
(7) Cerebral arteries
(8) The blood vessels that branch towards the neck and arms. (brachiocephalic trunk)
(9) Cardiac veins
(10) Pulmonary veins
(11) superior vena cava
(12) inferior vena cava
(13) aortic arch
(14) Thoracic aorta
(15) abdominal aorta
(16) Common iliac arteries
(17) Descending aorta to the bifurcation of aorta
"Central nervous system" means the brain, the cortex and medulla
"Continuous use" related to medical devices means
(1) Use of medical devices without interruption, excluding temporary suspension

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According to the method of use of the medical device or temporarily removing medical devices For
certain purposes, such as cleaning or sterilization.
(2) Cumulative use of medical devices by bringing other medical devices Which is a medical device type
The same is used immediately instead as the product owner intended.
"Duration of use" means
(1) Transient is a condition that is in continuous use for less than 60 minutes.
(2) Short term is a condition that is normally used continuously for 60 minutes to 30 days.
(3) Long term is a condition that is used continuously for more than 30 days.
"Harm" means physical injury or damage to health.
Public or property Or the environment
"Hazard" (hazard) means things that are likely to cause danger. "Immediate danger" means a situation in
which the patient is at risk.
For the loss of life or important body functions, if there are no preventive measures in a timely manner,
"risk" means the sum of the probabilities of the likelihood of danger, and the severity of danger.
2. Criteria for classification of medical devices that are not medical devices for in-vitro diagnostic
According to risk
2.1 Medical devices that are non-Invasive Medical Devices
Principle 1: All medical devices that do not enter the body Which in contact with the skin that has
Wounds are classified as a medical device of type 1, if intended to be used to close a wound (mechanical
barrier) by pressing or absorbing liquid that flows out of the wound only. For example, medical devices
used for treatment Primary intent wounds
It is classified as a medical device of type 2, if intended for use with wounds that have been torn to the
dermis, including medical devices intended for managing the microstructure environment
(microenvironment) of the wound.
It is a type 3 medical device if intended for use with wounds that have been torn to the dermis, and can
only heal secondary wounds.
Principle 2: All medical devices that do not enter the body which is used as a passage or store
• body fluid or the tissue of the body
• other liquid, or
• Gas
Classified as a medical device type 1, if intended for infusion, administration, or introduction (substance)
into the body.
Classified as a medical device of type 2, if connected to a medical device of type 2 or higher.
Classified as a medical device type 2, if the medical device intended for using.
• It is the passage of blood, or

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 Store or pass through other fluids in the body, or

 Collect some organs or the tissue of the body.
 Classified as a medical device type 3, if it is a blood bag.
Principle 3: All medical devices that do not enter the body, which is intended for use in improving
biological components or the chemistry of
 Blood
 Other liquids from the body
 Other liquids
Classified as a Category 3 medical device if intended for intravenous infusion into
Body (infusion)
Classified as a medical device type 2, if the treatment consists of filtering Centrifuge
(centrifuging) or gas or heat exchange
Principle 4: All other medical devices that are not injected into the body other than the criteria 1-3,
classified as Category 1 medical devices
2.2 Invasive Medical Devices
Principle 5: All medical devices that penetrate into the body through openings of the body (excluding
the penetration into the body through surgery)
• not intended to be connected to a capable medical device, or
• intended to be connected to medical devices of type 1 only.
Classified as a medical device, type 1, if intended for temporary use
Classified as a type 2 medical device if intended for use on the outside surface of the eyeball or likely to
be absorbed by mucous membranes.
Classified as a medical device, type 2, if intended for short-term use.
Classified as a medical device type 1, if intended for short-term use in the mouth, throat, ear canal,
eardrum or nose.
Classified as a medical device type 3, if intended for long-term use.
Classified as a medical device type 2, if intended for long-term use in the mouth to the throat. In the ear
canal to the eardrum or the nasopharynx and does not tend to be absorbed by mucous membranes
All medical devices that penetrate the body through the openings of the body (Not including the assault
Into the body through surgical procedures) intended to connect with medical devices of type 2 or higher
shall be classified as a medical device type 2.
Principle 6: Medical devices penetrate into the body through all surgical procedures intended For
temporary use shall be classified as a medical device type 2.
If it is a surgical medical device that is reused shall be classified as a medical device type 1, or
If intended to supply energy in the form of ionizing radiation that is classified as ionic medical devices of
type 3, or
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If aiming for biological effects or completely or completely absorbed shall be classified as medical
devices of category 3, or
If intended to administer drugs as a delivery system and operate as to cause danger by considering the
usage pattern shall be classified as medical devices of category 3, or
If intended to be directly exposed, the central nervous system is classified as a Category 4: medical
device, or
If intended to diagnose disease, monitor or fix heart defects, or the central circulatory system through
direct contact with those parts of the body shall be classified as a medical device type 4.
Principle 7: Medical devices penetrate into the body through all surgical procedures intended For short-
term use shall be classified as a medical device type 2.
If intended to administer medicine shall be classified as medical devices of category 3, or
If intended to cause chemical changes in the body (except medical devices that are inserted in the
teeth), classified as category 3 medical devices, or
If intended to give biological results Or completely or completely absorbed Classified as a medical device
type 4 or
If intended to touch directly with the central nervous system Classified as a medical device, type 4
If intended to diagnose disease, monitor or fix heart defects Or the central circulatory system through
direct contact with these parts of the body Classified as a medical device, type 4
Principle 8: All implanted medical devices And penetrating into the body by Surgery intended for long-
term use Classified as a medical device type 3
If intended to be put in the teeth Classified as medical devices of category 2 or
If intended to touch directly with the heart Central circulatory system Or the central nervous system is
classified as a Category 4 medical device, or
If intended to sustain or save lives Classified as a medical device type 4, or if intended to be a medical
device implanted in the body with strength shall be classified as a medical device type 4.
If intended to provide biological results or completely absorbed shall be classified as a medical device
Category 4, or
If intended to administer medicine shall be classified as a medical device type 4 or if intended to cause
chemical changes in the body (except medical devices that are inserted in teeth) shall be classified as a
medical device type 4, or
If it is an artificial breast implanted in the body and it shall be classified as a medical device, type 4
2.3 Active Medical Devices
Principle 9 (1) All medical devices with therapeutic power intended for administration or energy
exchange shall be classified as a medical device type 2.
If intended to manage or exchange energy into or out of the body which is likely will be dangerous,
including radiation that causes the breakdown of ions considering the nature, density, and position of
energy management or exchange shall be classified as a medical device type 3.

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Principle 9 (2) All medical devices with power intended to control or monitor performance Of medical
devices that have the power used in treatment of type 3 or intended to cause a direct effect on the
performance Of medical devices Classified as a medical device type 3
Principle 10 (1) Medical device with power intended for diagnosis Classified as a medical device type 2
If intended to supply energy absorbed by the human body (Except medical devices that are used to To
give light to the patient's body only In which the light is in the visible or near infrared spectrum Classified
as medical device type 1) or
If intended to create a distribution of radiopharmaceuticals in the body (radiopharmaceuticals) or
If intended to diagnose or monitor vital physiological processes directly
If specifically aimed for
• Monitoring vital physiological parameters which cause acute adverse effects on the patient, for
example changes in cardiac performance, respiration, central nervous system function Classified as
medical devices of category 3, or
• Clinical diagnosis to show that the patient is in an acute danger condition shall be classified as a
medical device type 3
Criteria 10: (2) Medical devices with the power intended to emit ionizing radiation and as diagnostic or
radiotherapy (interventional radiology), including medical devices that control or monitor such medical
devices Or effective medical devices Directly affecting the performance of medical devices shall be
classified as a medical device type 3.
Principle 11: Medical equipment with all power intended to administer and / or eliminate drugs Body
fluids or other substances enter or exit the body shall be classified as a medical device type 2
Medical device under the above paragraph if it is likely to cause danger shall be classified as a medical
device type 3, based on the nature of the substances, related body parts, forms and channels of
administration or elimination.
Principle 12: Medical devices with power that is not within the criteria specified above, classified as
medical devices of category 1
2.4 Additional rules
Principle 13: Medical device that contains medicine (according to the law on drugs) is a component
integrated into Part of the medical device to enhance the work of the medical device to the body shall
be classified as a medical device, type 4
Principle 14: All medical devices manufactured or contain these things Classified as a medical device,
type 4
• Membranes and/or animal derivatives which cannot grow, or
• Membranes and/or microbial derivatives, or from the consolidation of a new gene structure

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If the medical device produces or has a component of non-viable animal tissues and in contact with
normal skin (intact skin) only, classified as medical device type 1.
Principle 15: All medical devices that are specifically intended to be used to sterilize or disinfect medical
devices at the end of the procedure shall be classified as a medical device type 3.
If aiming to disinfect the medical device before the end of the sterile process or before sterilization at a
higher level shall be classified as medical devices of category 2, or
If intended only for disinfection cleaning, rinsing, or moistening for contact lenses is classified as a type 3
medical device.
Principle 16: All medical devices used for contraception or prevent infectious diseases from sexual
intercourse shall be classified as a medical device type 3.
If it is a medical device that is implanted in the body or invades into the body for the long term shall be
classified as a medical device, type 4.
3. In the event that a medical device may be classified in more than one category according to the above
rules to classify medical devices Is the type that has the highest risk.
4. In the event that the medical device is designed to be used in conjunction with other medical devices
as well To classify used medical devices separately, consider classifying each medical device item.
5. In the case of medical devices with more than one purpose to classify medical devices according to
the purpose of use with the highest risk.

Book 136 Chapter 56 Gor Page 186 Government Gazette 30 April, 2019

Medical Device Act (Issue 2) B.E. 2562

His Majesty King Maha Vajiralongkorn Bodindradebayavarangkun
Issued on 26 April, 2019, the forth year on the Reign.

His Majesty King Maha Vajiralongkorn Bodindradebayavarangkun has the royal command to announce
that it is appropriate to amend the Medical Devices Law.
This Act contains certain provisions relating to the restriction of personal rights and freedoms, which
Section 26, together with Section 37 and Section 40 of the Constitution of the Kingdom of Thailand, can
be done by virtue of the provisions of law.
Reasons and necessity to restrict rights and freedoms of persons under this Act To determine the
control measures for medical devices in accordance with the ASEAN Agreement on Medical Device
Provisions And suitable for the situation of trade and industry changes regarding Medical devices are
also included, so people can be safe from using quality medical devices. And meets international
standards The enactment of this Act is in accordance with the conditions provided in Section 26 of the
Constitution of the Kingdom of Thailand.
Therefore ordered by His Majesty Be enacted with the advice and consent of The National Legislative
Assembly acts as follows:
Section 1 This Act is called "Medical Device Act (Issue 2) B.E. 2560"
Section 2 This Act shall come into force from the day following the date of its publication in the
Government Gazette.
Section 3 The provisions in the definition of "Medical device" under Section 4 of the Medical Device Act
B.E. 2551 and to use the following instead
"" Medical device "means
(1) Tools, mechanical appliances, materials used to enter into the body, reagent used in and outside the
laboratory, software products or any other objects that the manufacturer or the product owner
intended specifically for use with one of the following humans or animals Regardless of whether it is
used, broken, shared, or combined with anything else.
(A) Diagnosis, prevention, monitoring, treatment, relief or treatment of diseases
(B) Diagnose, follow, treat, relieve or treat injuries
(C) inspect, replace, correct, adapt, support or support anatomical aspects or processes
Physiological body
(D) Foster or save lives
(E) Birth control or growth aid
(F) Assisting or helping to compensate for disability or disability
(G) Provide information from specimens from the body For medical purposes or
Diagnosis
(H) destroy or disinfect for medical devices
(2) Accessories for use with medical devices under (1)
(3) Tools, appliances, machinery, products or other materials prescribed by the Minister that Is a medical
device
Achievement of the purpose of the things referred to in (1) which occur in the human body or animal
Must not be caused by pharmacological processes, immunology or mainly metabolic reactions.
Section 4 Add the definition of "Accessories" during the definition of "Medical device" and the word
"manufacture" in Article 4 of the Medical Device Act 2008.
"Accessories" means articles, appliances, or products that the manufacturer or the product owner
Intended only for use with medical equipment to help or make the medical device work according to the
intended purpose of the medical device.”
Section 5 The definition of "Notifier" shall be added between the definitions of "Detailed informer" and
the word "establishment registration" in Section 4 of the Medical Device Act B.E. 2551. "" Informant
"means the person who receives a certificate of receipt under this Act. In the case of a juristic person
Being the person receiving the certificate of registration shall include the person appointed by the
juristic person to be the business operator.
"Section 6 The provisions of (1) of Section 6 of the Medical Device Act shall be repealed.
B.E. 2551 and to use the following instead
"(1) Medical device group or medical device group according to the level of risk that may cause harm to
the health of the body or life of humans or animals, impact on public health as well as guidelines
Methods and conditions for the production or import of the said medical device to determine the
control measures of medical device groups or medical devices as follows:
(A) Medical device groups or medical devices that must be licensed by the manufacturer or importer (B)
a group of medical devices or other medical devices that manufacturers or importers have to declare in
detail (c) a group of medical devices or medical devices that a manufacturer or importer has to register
Section 7 (2) of Section 6 of the Medical Device Act B.E. 2551
Section 8 The provisions of (3) of Section 6 of the Medical Device Act B.E. 2551 shall be repealed and
replaced with the following:
"(3) A group of medical devices or medical devices that a seller must obtain permission from Including
rules, procedures, and conditions for selling medical devices "
Section 9 The provisions of (17) of Section 6 of the Medical Device Act B.E. 2551 shall be repealed and
replaced by the following:
"(17) Any place in the Kingdom shall be a check point for imported medical equipment"

Section 10 The following provision shall be added as (19) (20) (21) and (22) of Section 6 of the Medical
Device Act B.E. 2551.
"(19) The maximum rate of expenditure and expenditures to be collected from the applicant in Part 1
Medical Procedure Approval Procedure of Chapter 2 Establishment Requesting and granting permission
Detailed list notification and notification
(20) the highest accounting fees and the accounting fees that are collected from experts, experts of the
organization, government organizations, or private organization, both domestically and internationally.
(21) The cost of evaluating academic documents Analysis Inspection of establishments Or examination
of medical devices for monitoring or surveillance To control the production, import and sale of medical
devices.
(22) Rules, procedures, and conditions for receiving money and paying money received from collection
in the process and consider allowing medical devices or monitoring or inspecting to control the
production, import and sale of medical devices."
Section 11 Added this to the third paragraph of Section 7 of the Medical Device Act 2008
"Appointing a qualified committee Shall be in accordance with the rules, procedures and conditions
announced by the Minister "
Section 12 The provisions of Section 11 of the Medical Device Act B.E. 2551 shall be repealed and the
following shall be replaced instead:
"Section 11 The Board shall have the following duties and powers:
(1) To give advice or opinions to the Minister regarding policies and measures relating to controls
Medical device in order to comply with this Act
(2) to give advice to the Minister regarding the issuance of notifications under this Act
(3) to give approval to the Secretary-General to issue notifications under this Act
(4) to approve the suspension and revocation of the establishment registration certificate, license or
specifications declaration receipt
(5) To perform any other duties as specified in this Act or as assigned by the Minister. "
Section 13 The following shall be added as paragraph two of Section 12 of the Act. Medical Equipment
B.E. 2551
"Appointment of a sub-committee for the operations in part 1 approval process Medical devices of
category 2 Establishment registration, requesting and granting permission, detailed notification, and
registration for representatives of the Office of the Public Sector Development Commission
Representatives of associations or foundations with objectives regarding consumer protection And
representatives of the association or Operators with the objective of producing, importing or selling
medical devices Subcommittee. The rules for the appointment of such qualified members under section
7 paragraph three shall apply mutatis mutandis. In this regard, in the Sub-Committee on Consideration
of Account Fees and Expenses, there shall be representatives of the Ministry of Finance as
Subcommittee also increased. "
Section 14 The name of Chapter 2, establishment registration, application for permission and permission
and specifications declaration Of the Medical Device Act B.E. 2551 and to use the following instead
"Category 2 Registration of establishments Requesting and granting permissions, listing details, nd
notifications"
Section 15 The provisions of Section 17, Section 18, Section 19 and Section 20 of the Medical Device Act
B.E. 2551 shall be repealed and replaced by the following:
"Section 17 An establishment registrant wishing to manufacture or import medical devices under
Section 6 (1) (a) shall submit an application for permission and when the licensor issues the license to
produce or shall import that medical device.
Application for and issuance of a license under paragraph one Shall be in accordance with the rules,
procedures and conditions prescribed in the Ministerial Regulations
The licensee under paragraph one shall comply with rules, procedures and conditions in production or
import medical devices prescribed by the Minister under Section 6 (1) (a).
Section 18 Registrar of establishments which produce or import medical devices as specified in the
announcement under Section 6 (1) (a) on the date of the announcement being in force and intending to
continue shall submit an application for approval within the time period specified in the announcement.
When submitting the said request after the deadline has been determined, it can be proceeded until the
permission order is not granted.
The information in section 17, paragraph two and paragraph three shall be given. Come into force
mutatis mutandis
Section 19.An establishment registrant wishing to manufacture or import medical devices under Section
6 (1) (b) or (c) shall submit a request for detailed specifications or registration, as the case may be, and
when the licensing authority issues a specifications declaration receipt or Noted receipt Then can
produce or import that medical device, listing details, the issuance of notification receipts, the
registration details and the issuance of notification receipts under paragraph one shall be in accordance
with the rules, procedures and conditions prescribed in the Ministerial Regulations, details informant or
informer under paragraph one must comply with the rules, procedures, and conditions for the
production or import of medical devices as prescribed by the Minister under Section 6 (1) (b) or (c).
Section 20 Import medical devices as specified In the announcement under Section 6 (1) (b) or (c) on the
date of the said announcement becoming effective and intended that will be proceed must file a
detailed listing request or make a notification within the specified time period In the announcement.
Once the request has been submitted within the time limit, proceedings may continue until an order has
been issued without accepting details or not accepting notification.
The information under Section 19, paragraph two and paragraph three Come into force mutatis
mutandis."
Section 16 The provisions of Section 25 of the Medical Device Act B.E. 2551 shall be repealed and the
following shall be replaced instead:
Section 25. Any person who sells a medical device stated in a Notification under section 6(3) on the
effective date of such Notification and wishes to continue operations must submit a licence application
within thirty days as from the effective date of the Notification. Upon the submission of such an
application within the prescribed period, the operations may continue until an order to reject a licence is
issued.
The provisions in section 24 paragraph two, paragraph three and paragraph four shall apply mutatis
mutandis.
Section 17 The provision in (4) of Section 27 of the Medical Device Act B.E. 2551 shall be repealed and
the following shall be replaced:
"(4) The sale of licensed medical devices, receipt of detailed notification, or notification receipt by
hospitals or medical and public health professionals for their patients or specific animals."
Section 18 The provision under (6) of Section 27 of the Medical Device Act B.E. 2551 shall be repealed
and the following shall be replaced:
"(6) Import of medical devices for patients or individual animals."
Section 19 The provision of Section 28 of the Medical Device Act B.E. 2551 shall be repealed and shall
use the following instead.
“Section 28. An establishment registration certificate, licence or specifications declaration receipt shall
also cover the employees and agents of the establishment registrant, licensee and specifications
provider.
The action of an employee or agent covered under paragraph one shall also be deemed to be the action
of the establishment registrant, licensee or specifications provider unless the establishment registrant,
licensee or specifications provider can prove that acquiring knowledge or control of such an action is not
possible.

Section 20 The following shall be added as the third paragraph of Section 29 of the Act. Medical devices
B.E. 2551
"The notification receipt under Section 19 shall be valid for five years from the date of the notification
receipt."
Section 21 The following provision shall be added as Section 30/1 of the Medical Device Act
2008.
"Section 30/1 In the event that the informant wishes to renew the notification receipt to submit the
request before the date of expiry of the certification receipt. Once the request is submitted and the
renewal fee is paid together with the request submission shall continue to operate the business until the
licensor has not allowed to renew the notification receipt, request for renewal of notification receipt
and permission to renew notification receipt Shall be in accordance with the rules, procedures and
conditions specified by the licensor.
The notifier whose receipt is not more than one month old shall submit a request for renewal and a
waiver request By showing the reason for not submitting an application for renewal within the deadline,
including paying the renewal fee But the request for waiver does not cause to be acquitted under
Section 91.
The request to renew the notification receipt after one month has elapsed since the expiry of the
notification receipt.
In the event that the licensing authority issues a refusal order to renew the notification receipt Renewal
of the renewal fee to the person requesting to renew according to part by calculating monthly from the
date of the order disallowing until the expiry date of Notification form for renewal Except in the case of
an appeal against an order refusing to renew the certificate, and the Minister has ordered the applicant
to renew the certificate of business If the Minister issues an appeal to dismiss the appeal from the date
of the appeal, the appeal shall be lifted. A fraction of one month, if up to fifteen days, is counted as one
month. "
Section 22 The following provision shall be added as Section 31/1 of the Medical Device Act B.E. 2551.
"Section 31/1 In the event that the information already registered has changed, the informer must
proceed to notify the licensing authority of the information.
Information notification under paragraph one Shall be in accordance with the rules, procedures, and
conditions stipulated by the licensor. "Section 23. Section 33 of the Medical Device Act B.E. 2551 shall be
repealed. Section 24:
Section 35/1, Section 35/2, Section 35/3, Section 35/4, Section 35/5, Section 35/6 and Section 35/7 in
Section 2 Enterprise Registration Requesting and granting permission, notification of specifications and
registration of the Medical Device Act B.E. 2551.
"Part 1 Medical device license approval process.
Section 35/1 The process of considering medical device approval in this part for document request
consideration, validation, evaluation of academic documents, examination, analysis, inspection of
establishments or the examination to issue a certificate of registration, licenses, specifications
notifications, notification receipts or assessment certificates As well as any consideration regarding
medical devices. The process for considering medical device approval under paragraph one must pay
attention on the importance to promote the production of medical devices in the country as well.
Section 35/2 In the process of considering a medical device license aside from officers of Food and Drug
Administration and the staff of the department under the Ministry of Public Health that has been
assigned To do business in the duties and powers of the Food and Drug Administration to have experts,
expert organizations, government agencies or private organization both domestically and internationally
Responsible for assessing Academic documents Analysis Inspection of establishments or inspection to
complete the process shall be considered allowing medical devices with convenience, speed, and
efficiency in the process to be considered and approved for the medical devices of the central and
provincial areas. In this regard, such persons, organizations or organizations must be listed by the Food
and Drug Administration.
Rules, procedures, and conditions in the process of considering medical device approval under
paragraph one Shall be in accordance with the Secretary-General with the approval of the Committee by
promulgated in the Government Gazette.
Expenses to be collected from the applicant in the process of considering the granting of medical devices
under paragraph one Shall be as prescribed by the Minister by the advice of the Committee. The
expenses to be collected must not exceed the maximum expense rate under Section 35/4 (2), with the
exception of all or partial expenses.
Section 35/3 The Secretary-General with the approval of the Committee has the power to announce in
The Government Gazette prescribes rules, procedures and conditions for obtaining experts, experts of
the organization Government agency or private organization for both domestically and internationally
under Section 35/2.
Announcement under paragraph one must specify qualifications, standards and operations of experts
Expert organization Government agency or private organization Both in the country and abroad, in the
event that there is a reason and necessity, the criteria, procedures and conditions for the acquisition of
such persons, departments or organizations may be waived in whole or in part.
Account fees that will be collected from experts Expert organization Government agency or private
organization Both domestically and internationally under paragraph one Shall be as prescribed by the
Minister with the advice of the Committee.The accounting fees to be collected must not exceed the
maximum accounting rates under Section 35/4 (1), however, all or part of the fees may be waived
Section 35/4 The Minister shall, with the advice of the Committee, Has the power to declare as follows
(1) The highest accounting fee rate that will be collected from experts Expert organization Government
agency Or private organization Both domestically and internationally
(2) The highest expense rate that has been collected by the applicant in the medical device approval
process
Highest accounting fees and maximum expenses rates under (1) and (2) when approved From the
Cabinet shall come into force
Section 35/5 The expenses collected under Section 35/2, paragraph three and Section 35/6, paragraph
three and the account fees collected under Section 35/3, paragraph three shall be the money of the
Food and Drug Administration, or an organization that has been assigned to do business in the duties
and powers of the Food and Drug Administration Which is collected, as the case may be, without having
to deliver the warehouse as income and paid for the following purposes:
(1) Compensation for persons, organizations or departments under Section 35/2.
(2) Expenses for the implementation of plans or projects which are in the public interest for protection
Medical device consumer.
(3) Expenses for the development of capacity of agencies and staff To develop work systems related to
Medical device license approval process And increase the efficiency of the process in the consideration
process Medical device authorization.
(4) Other expenses that are related and necessary in relation to the operation to increase the efficiency
in the process shall be considered and approved for the medical devices as prescribed by the Minister.
Section 35/6 In monitoring, inspecting, or surveillance to control the production, import and sale of
licensed medical devices, detailed notification receipt, notification receipt or assessment certificate, as
the case may be, when there are reasonable grounds to suspect that a medical device may not be up to
standard or unsafe to use. The information in section 35/2, first and second paragraph shall be in force
mutatis mutandis.
The cost of evaluating academic documents Analysis Inspection of establishments Or examination of
medical devices under paragraph one To the applicant The establishment registrant, licensee,
specifications provider, informer, manufacturer, importer or seller of medical device shall be responsible
for expenses, as the case may be.
Expenses under paragraph two Shall be as prescribed by the Minister with the advice of the Committee.
The expenses to be collected must not exceed the maximum expense rate under Section 35/4 (2), with
the exception of expenses for the part or the whole.
Section 35/7 The receipt of money under Section 35/2, paragraph three, Section 35/3, paragraph three
and Section 35/6, paragraph three and payment under Section 35/5 shall be in accordance with the
rules, procedures and conditions prescribed by the Minister by the advice of this committee, with the
approval of the Ministry of Finance."
Section 25 The provisions of Section 36 of the Medical Device Act B.E. 2551 shall be repealed and the
following shall be replaced instead:
"Section 36. Any establishment registrant under section 15, licensee under section 17 or section 24,
detailed list informant or informant under section 19, who ceases the registered business The licensed
establishment has provided detailed lists, or registered under this Act Must notify the dissolution in
writing, and also submit the establishment registration certificate, license or notification receipt, details
informant, as the case may be, shall be given to the licensing authority within thirty days from the date
of the cessation of business and it shall be considered that the establishment registration certificate,
license, specifications list notification or the receipt from the expiration date
The dissolution of the business of the licensee or the specifications provider under paragraph one shall
specify the number of remaining medical devices and storage of such medical devices in accordance
with the rules, procedures and conditions prescribed by the Secretary-General by publication in the
Government Gazette.
Any establishment registrant ceases the business that has been registered for establishment. If not
informing the dissolution of the business licensed Receipt of detailed notification or notification receipt
The license is considered Receipt of detailed notification or the expiration date.
Any establishment registrant under section 15, licensee under section 17 or section 24, specifications
provider or informant under section 19, who ceases business without notifying under paragraph one,
shall be deemed to be an establishment registration certificate, license, specifications declaration
receipt or the receipt of the expiration date from the date of dissolution. "
Section 26 The provision under paragraph one of Section 39 of the Medical Device Act B.E. 2551 shall be
repealed and replaced by the following:
"Section 39 In the case where the establishment registrant, licensee, specifications list or the informant
dies And the heirs or those with the consent of the heirs expressed the intention to the licensor to
request shall be continued to operate the business within ninety days from the date of establishment
registrar, licensee, and informant of the details or the informant has deceased. When the licensor has
examined and determined that that person had the qualifications under Section 16 or Section 26, as the
case may be, the official must continue to operate the business until the registration certificate,
establishments, licenses, specifications lists or the certificate of expiration receipt and it shall be
considered that the performer Intention to be a business registration registrar, licensee, and
specifications provider or informant under this Act since the date of establishment registration, licensee,
specifications list or the deceased informant."
Section 27 For Chapter 4, responsibilities on the place of business registration, licensee, specifications
provider and seller of the Medical Device Act B.E. 2551 shall be repealed and replaced by the following:
"Section 4 In front of a business registration registrant, licensee, specifications provider, informant and
seller"
Section 28 The provisions of Section 40 and Section 41 of the Medical Device Act B.E. 2551 shall be
repealed and replaced with the following:
Section 40. An establishment registrant, licensee or specifications provider shall not manufacture,
import, sell or store medical devices in a place other than as specified in the establishment registration
certificate, licence or specifications declaration receipt, except for:
(1) temporary storage permitted by the licensor in accordance with rules, procedures and conditions
prescribed by Notification of the Minister by the advice of the Board;
(2) direct sale to a medical and public health practitioner;
(3) assembly for the installation of medical devices in accordance with the rules, procedures and
conditions prescribed by Notification of the Minister by the advice of the Board.
Section 41. An establishment registrant, licensee or specifications provider shall perform the following
acts:
(1) control and supervise operations pertaining to the manufacture, import and sale of medical devices
to conform with the quality system for manufacture, import or sale of medical devices under section
6(5);
(2) provide a controller of manufacture, import or sale of medical devices under section 6(7) and to
supervise such person’s total compliance with section 6(7);
(3) keep records of manufacture, import or sale of medical devices to be made available for inspection
by a competent official and reporting to the licensor in accordance with the rules, procedures and
conditions prescribed by Notification of the Minister;
(4) report abnormal functioning of a medical device or undesired result occurring to a consumer as well
as report steps taken to remedy such results to the licensor, regardless of whether the result occurred in
the country or outside of the country, in accordance with rules, procedures and conditions prescribed by
Notification of the Minister;
(5) arrange channels for complaints Complaint record And the complaint management system regarding
Medical devices that are manufactured, imported or sold for inspection by the competent official in
accordance with the rules, procedures and conditions prescribed by the Minister.
(6) provide a signboard indicating the place of manufacture, place of import, place of sale or place of
storage of medical devices to be displayed in a conspicuous location at such place as specified in the
establishment registration certificate, licence or specifications declaration receipt, as the case may be, in
accordance with the rules, procedures and conditions prescribed by Notification of the Minister;
(7) provide a notice displaying the name and qualifications of the controller in the case of a medical
device under section 6(7) to be displayed in a conspicuous location at the place of manufacture, place of
import or place of sale in accordance with the rules, procedures and conditions prescribed by
Notification of the Minister;
(8) display the establishment registration certificate, licence or specifications declaration receipt in a
conspicuous and noticeable location at the place specified in the establishment registration certificate,
licence or specifications declaration receipt;
(9) provide technical documentation confirming that one’s medical device meets the required quality,
standard, efficiency and safety to be examined or submitted to an official upon request in accordance
with the rules, procedures and conditions prescribed by the Secretary-General by a Notification
published in the Government Gazette.
Section 29 The provisions of Section 44 of the Medical Device Act B.E. 2551 shall be repealed and the
following shall be replaced:
"Section 44 An establishment registrant, licensee, specifications provider or informant who produces or
imports medical devices Provide labels and medical device documentation, which must Do not show
false or exaggerated statements.
Labeling and medical device documentation shall be in accordance with the rules, procedures and
conditions announced by the Minister to the seller of medical devices to have signs or labels and
medical device documentation, as the case may be, as the registration holder In the establishment,
licensee, informer, informer or informer under paragraph one provided "Section 30, the provisions of
paragraph 45 of Section 45 of the Medical Device Act B.E. 2551 shall be repealed and the following
provisions shall apply:
Section 45. Subject to section 44, an establishment registrant, licensee or specifications provider who
manufactures or imports a medical device under section 6(13) shall display the shelf life, warning,
prohibited uses or cautions on the label of medical device documentation.
Section 31 The provisions of (5) and (6) of Section 46 of the Act Medical device B.E. 2551 and to use the
following instead.
"(5) Medical devices manufactured or imported that do not meet the permission, notify details, or
register
(6) The medical device whose license or specifications notification has been revoked under Section 70 or
the notification receipt has been revoked under Section 70/1 "
Section 32 The following provision shall be added as Section 46/1 of the Medical Device Act B.E. 2551
"Section 46/1 No person shall be allowed to sell a medical device without a license, receipt of detailed
notification or notification receipt."
Section 33 The provision under (3) of Section 47 of the Medical Device Act B.E. 2551 shall be repealed
and replaced by the following:
"(3) A medical device that shows that it is a licensed medical device Notified details or notified, which is
not true "
Section 34 The provisions of (1) of Section 48 of the Medical Device Act B.E. 2551 shall be repealed and
replaced by the following:
"(1) Medical devices of quality or standard that are not as permitted Report details or register "
Section 35 The provisions of Section 53 of the Medical Device Act B.E. 2551 shall be repealed and shall
be replaced by the following:
"Section 53 After the announcement under Section 6 (17) is made, the importation of medical devices
must pass Inspection of the officers at the medical device checkpoint. "
Section 36 The provisions of Section 55 of the Medical Device Act B.E. 2551 shall be repealed and the
following shall be replaced instead:
"Section 55 for the purpose of protecting the health and safety of consumers When it appears that Any
medical device that has quality, standards, or efficacy is not as permitted. Have been notified of details
or received notification Unsafe to use May be harmful to health, or if there is a change in standards, the
Secretary-General shall have the following powers:
(1) issue a written order to the licensee Detailed informer and the record taker Is allowed Notified
details Or be notified
(2) Issue a written order to the manufacturer, importer, seller or person who has a medical device in
possession to take advantage, modify or improve medical devices that are manufactured, imported, sold
or have in possession
(3) issuing a written order instructing the manufacturer, importer or seller of medical device to refrain
from producing, importing or selling medical devices or perform other related tasks as determined by
the Commission
(4) Announcement of examination results or analysis of medical devices And announcing violations Or
failing to comply with (2) or (3) to the public immediately And in the case the Secretary-General deems it
appropriate to notify Related parties also know
(5) to collect medical devices from manufacturers, importers, sellers or persons possessing or Instruct
manufacturers, importers or sellers to store medical devices that they have manufactured, imported or
sold back from the market. Within the period specified by the Secretary-General And has the power to
order to destroy or manage as appropriate in the case if it is found that the medical device is a medical
device under Section 46, provided that the manufacturer, importer, seller or possessor shall be
responsible for the cost of the following operations:"
Section 37 The following shall be added as paragraph four of Section 57 of the Medical Device Act B.E.
2551.
"Advertising tools Direct doctors to the medical and public health professionals, the Minister, with the
advice of the Committee, has the power to prescribe medical devices as well as rules, methods and
advertising conditions that are exempted from requesting permission "
Section 38 The provisions of Section 63 of the Medical Device Act B.E. 2551 shall be repealed and
replaced by the following:
Section 63. A licensee, specifications provider and person having duties related to the manufacture,
import, sale or storage of medical device shall assist a competent official executing duties under section
61 and section 66 paragraph two.
"Chapter 9 Suspension and revocation of business registration certificates License, specifications
notification, or cancellation of notification receipts. "
Section 40 The following shall be added as Section 70/1 of the Medical Device Act B.E. 2551.
"Section 70/1 For the purpose of protecting the health and safety of consumers, the licensor has the
power to cancel the receipt of notification if any of the following events occur:
(1) The information of the registered medical device is inaccurate
(2) The medical device registered is a fake medical device or a medical device that is unsafe to use
(3) The informant has changed the purpose of use or benefit of the medical device into medicine
Psychoactive substance (4) The registered medical device does not have the benefits as registered, with
the result of reliable academic documents. "
Section 41 The provisions of Section 71, Section 72 and Section 73 of the Royal Decree
Medical device B.E. 2551 and to use the following instead
"Section 71 In the case where the grantor requires that the medical device that is licensed Notified
Detailed or registered, changed to medicine Psychotropic substances Drugs that are harmful to
dangerous objects or cosmetics To the licensee Detailed informer Or the informant Shall be in
accordance with the rules, procedures, conditions and period specified by the Secretary-General by
published in the Government Gazette
In the event that no action has been taken under paragraph one within the time specified by the
Secretary-General, the license, specifications declaration receipt Or the expiration notice
Section 72 Order to suspend or revoke an establishment registration certificate, license or specifications
declaration receipt And the order to cancel the notification receipt To be made in writing to notify the
registrar Establishment Licensee Person providing details Or the informant, as the case may be, and in
the case where the establishment registrant, licensee, specifications provider is not found Or the notifier
or establishment registrar, licensee, specifications list Or the informant does not accept the said order
The order shall be posted in a conspicuous place and easily visible at the place specified on the
establishment registration certificate, license, specifications declaration receipt, or notification receipt
And the establishment registrant, licensee, specifications provider Or the person who informs the
statement from the date of closing the order
The order to suspend or revoke the establishment registration certificate, license, specifications list
receipt and the order to cancel the notification receipt can be advertised in the newspaper or by other
means as well
Section 73 Subject to Section 46, an establishment registration revocation permit, specifications
declaration receipt or the person receiving the notification receipt shall sell their medical devices
Remaining to the establishment registrar, licensee, who gives details ore another notifier or the person
who the licensee deems appropriate within one hundred and eighty days from the date of knowing the
order, the revocation of the establishment registration certificate, the license, the detailed specifications
receipt Or the order to cancel the notification receipt or the known date of making the decision of the
Minister; unless, the licensor will extend the said period."
Section 42 The provisions of Section 74 and Section 75 of the Medical Device Act B.E. 2551 shall be
repealed and replaced by the following:
"Section 74 In the case where the licensor does not issue an establishment registration certificate,
license, specifications declaration receipt or notification receipt or not issuing an assessment certificate
under section 22 or not allowing to renew the establishment registration certificate, license,
specifications notification or the notification receipt applicant has the right to appeal the said order in
writing to the Minister within thirty days from the date of receipt of the notification of non-issuance of
establishment registration certificate, specifications declaration receipt or notification receipt without
issuing an assessment certificate under section 22 or refuse to renew an establishment registration
certificate, license, specifications declaration receipt or notification receipt, as the case may be, the
decision of the Minister shall be final.
In the event that the licensing authority refuses to renew the establishment registration certificate,
license, specifications declaration receipt or notification receipt before the Minister has a decision on
the appeal under paragraph two. The Minister has the power to grant permission to conduct business
for a time when there is a request of the appellant.
Section 75 An establishment registrant, licensee, specifications provider which has been ordered
Suspend or revoke establishment registration certificate, license, specifications declaration receipt or
informant Which has been canceled the notification receipt Has the right to appeal in writing to the
Minister within thirty days from the date of acknowledgment of the order.
The appeal under paragraph one shall not suspend the enforcement of the suspension order or the
revocation of the establishment registration certificate, license, specifications notification or the order
to cancel the notification receipt. The decision of the Minister shall be final.
Section 43 The provisions of Section 86 and Section 87 of the Medical Device Act B.E. 2551 shall be
repealed and replaced by the following:
"Section 86 Any person who produces or imports a medical device under Section 6 (1) (a) without having
obtained a license under Section 17 paragraph one or Section 18 paragraph one, as the case may be,
shall be punished with imprisonment not exceeding three years, or a fine not exceeding three hundred
thousand baht or both.
Any licensee to produce or import medical devices under Section 6 (1) (a) who fails to comply with
Section 17 paragraph three or Section 18 paragraph two shall be liable to a fine not exceeding one
hundred and fifty thousand baht.
Section 87 Any person who produces or imports a medical device under Section 6 (1) (b) without
receiving a notification receipt, or informed details under section 19 paragraph one or section 20
paragraph one, as the case may be, shall be punished with imprisonment not exceeding two years, or a
fine not exceeding two hundred thousand baht or both.
Any person who produces or imports a medical device under Section 6 (1) (c) without receiving a
certificate of receipt under Section 19 paragraph one or Section 20 paragraph one, as the case may be,
shall be punished with imprisonment not exceeding one year or a fine not exceeding one hundred
thousand baht or both.
Any specifications provider who fails to comply with section 19 paragraph three or section 20 paragraph
two shall be liable to a fine not exceeding one hundred thousand baht.
Any informer who fails to comply with Section 19 paragraph three or Section 20 paragraph two shall be
liable to a fine not exceeding fifty thousand baht."
Section 44 The provisions of Section 91 and Section 92 of the Medical Device Act B.E. 2551 shall be
repealed and replaced with the following:
"Section 91 Any licensee or specifications provider who produces, imports or sells medical devices after
the license or specifications declaration receipt has expired but submitted a request to renew a license
or the receipt of specifications declaration within the time specified under Section 30 paragraph three
shall be liable to a fine on a daily basis for one thousand baht a day all the time when not yet submitting
a license renewal request or detailed notification receipt.
Any establishment registrant or registrant who produces, imports or sells medical devices after the
establishment registration certificate or age registration certificate but has submitted a request to
renew the registration certificate the establishment within the time specified under Section 30
paragraph three or submit an application for renewal of the notification receipt Within the time
specified under paragraph three of Section 30/1, shall be liable to a daily fine of five hundred baht
Throughout the time that the request for renewal of the establishment registration certificate or
notification receipt has not been submitted.
Section 92 Any licensee or specifications provider who does not comply with Section 31 shall be liable to
imprisonment for a term not exceeding one year or a fine not exceeding one hundred thousand baht, or
both.
Any establishment registrant who fails to comply with Section 31 shall be liable to imprisonment for a
term not exceeding six months or a fine not exceeding fifty thousand baht, or both."
Section 45 The following shall be added as Section 92/1 of the Medical Device Act B.E. 2551.
"Section 92/1. Any informer who does not comply with the first paragraph of Section 31/1 shall be
punished with imprisonment. Not over six months Or a fine not exceeding fifty thousand baht, or both."
Section 46 The provisions of Section 93 of the Medical Device Act B.E. 2551 shall be repealed and
replaced with the following:
"Section 93 Any licensee or specifications provider who does not comply with Section 32 paragraph one,
shall be liable to a fine not exceeding ten thousand baht.
Any establishment registrant who fails to comply with section 32 paragraph one shall be liable to a fine.
Not more than five thousand baht."
Section 47 The provisions of Section 95 and Section 96 of the Medical Device Act B.E. 2551 shall be
repealed and the following shall be replaced.
"Section 95. A licensee under section 17 or section 24 or a specifications provider under section 19
whoever ends the business by not complying with section 36 paragraph one shall be liable to a fine not
exceeding ten thousand baht.
Any establishment registrant under section 15 or the informant under section 19 shall cease the
business by not complying with Section 36, paragraph one, shall be liable to a fine not exceeding five
thousand baht.
Section 96. Any licensee under section 17 or section 24 or a specifications provider under section 19 who
has a license or a specifications declaration receipt or the licensor does not allow to renew the license or
specifications receipt without informing under Section 37, paragraph one, shall be liable to a fine Not
more than ten thousand baht.
Any establishment registrant under Section 15 whose registration certificate expires or the licensor does
not allow to renew the establishment registration certificate without informing under Section 37,
paragraph one, shall be liable to a fine not exceeding five thousand baht.
Section 48 The provisions of Section 99 and Section 100 of the Act shall be repealed. Medical device B.E.
2551 and to use the following instead.
Section 99. Any establishment registrant, licensee or specifications provider who violates section 40 shall
be liable to imprisonment for a term not exceeding one year or a fine not exceeding one hundred
thousand baht, or both.
Section 100. Any establishment registrant, licensee or specifications provider who fails to comply with
section 41(1) or (2) shall be liable to imprisonment for a term not exceeding one year or a fine not
exceeding one hundred thousand baht, or both.
Any establishment registrant, licensee or specifications provider who fails to comply with section 41(3),
(4) or (8) shall be liable to imprisonment for a term not exceeding six months or a fine not exceeding
fifty thousand baht, or both.
Any establishment registrant, licensee or specifications provider who prepares a false record or report
under section 41(3), prepares a false report under section 41(4) or provides false technical
documentation under section 41(8) shall be liable to imprisonment for a term not exceeding one year or
a fine not exceeding one hundred thousand baht, or both.
Any establishment registrant, licensee or specifications provider who fails to comply with section 41(5),
(6) or (7) shall be liable to a fine not exceeding one hundred thousand baht.”
Section 49 The following shall be added as Section 100/1 of the Medical Device Act B.E. 2551 (2008)
"Section 100/1 Any establishment registrant or informer who does not comply with Section 41 (1) (2) (3)
(4) or (9) shall be liable to imprisonment for a term not exceeding six months or a fine not exceeding
fifty thousand baht or both.
Any establishment registrant or notifier shall prepare a report or report under section 41 (3), prepare a
report under section 41 (4), make a memorandum of complaint under section 41 (5) or provide
information False academic documents under section 41 (9) shall be liable to imprisonment for a term
not exceeding six months or a fine not exceeding fifty thousand baht or both
Any registered registrant or notifier who fails to comply with Section 41 (5) shall be liable to
imprisonment for a term not exceeding three months or a fine not exceeding thirty thousand baht or
both.
Any registrant, establishment or informant who fails to comply with Section 41 (6) (7) or (8), as the case
may be, shall be liable to a fine not exceeding fifty thousand baht. "
Section 50 The provisions of Section 103 and Section 104 of the Medical Device Act B.E. 2551 shall be
repealed and use the following instead.
“Section 103. Any establishment registrant, licensee or specifications provider who manufactures or
imports a medical device without complying with section 44 paragraph one shall be liable to
imprisonment for a term not exceeding one year or a fine not exceeding one hundred thousand baht, or
both.
Any person under paragraph one who fails to comply with section 44 paragraph two shall be liable to a
fine not exceeding one hundred thousand baht.
Any vendor of medical device who fails to comply with section 44 paragraph three shall be liable to a
fine not exceeding fifty thousand baht.
Section 104. Any establishment registrant, licensee or specifications provider manufacturing or
importing a medical device under section 6(13) who fails to comply with section 45 paragraph one shall
be liable to a term of imprisonment not exceeding one year or a fine not exceeding one hundred
thousand baht, or both.
Any person under paragraph one who fails to comply with section 45 paragraph two shall be liable to a
fine not exceeding one hundred thousand baht.
Any person under paragraph one who fails to comply with section 45 paragraph two shall be liable to a
fine not exceeding fifty thousand baht.
Section 51 The provisions of Section 106 of the Medical Device Act B.E. 2551 shall be repealed and
replaced by the following:
Section 106. Any person who manufactures or imports a medical device not in conformity with
standards in violation of section 46(2) shall be liable to imprisonment for a term not exceeding three
years or a fine not exceeding three hundred thousand baht, or both.
Any person who sells a medical device not in conformity with standards in violation of section 46(2) shall
be liable to imprisonment for a term not exceeding one year or a fine not exceeding one hundred
thousand baht, or both.
Section 52 The provisions of Section 109 of the Medical Device Act B.E. 2551 shall be repealed and
replaced by the following:
Section 109. Any person who manufactures or imports a medical device which is not in accordance with
a licence or declared specifications in violation of section 46(5) shall be liable to a fine not exceeding two
hundred thousand baht.
Any person who sells a medical device which has been manufactured or imported not in accordance
with a licence or declared specifications in violation of section 46(5) shall be liable to a fine not
exceeding one hundred thousand baht.
Section 53 The following provision shall be added as Section 109/1 of the Medical Device Act B.E. 2551
"Section 109/1 Any person who sells a medical device that does not receive a license or does not receive
a list receipt Which is a violation of Article 46/1, shall be liable to imprisonment for a term of two years
or a fine not exceeding two hundred thousand baht or both.
Any person who sells a medical device that does not receive a notification receipt in violation of Article
46/1 shall be liable to Not over a year or a fine not exceeding one hundred thousand baht Or both. "
Section 54 Increase This is the third and second paragraph of Section 110 of the Medical Device Act B.E.
2551.
"Any person who produces or imports a medical device whose notification receipt has been revoked in
violation of Article 46 (6) shall be liable to imprisonment for a term not exceeding three years or a fine
not exceeding three hundred thousand baht or both.
Any person who sells a medical device whose notification receipt has been revoked in violation of Article
46 (6) shall be liable to imprisonment for a term not exceeding six months or a fine not exceeding fifty
thousand baht or both. "
Section 55 The provisions of Section 113 of the Medical Device Act B.E. 2551 shall be repealed and
replaced with the following:
"Section 113 Any importer of a medical device who does not comply with Section 53 shall be punished
by a term of not less than one year or a fine not exceeding one hundred thousand baht, or both "
Section 56 The following shall be added as the third paragraph of Section 114 of the Act. Medical devices
B.E. 2551
"Any informer who does not comply with the order of the Secretary General under Section 55 (1) shall
be punished with imprisonment not exceeding six months or a fine not exceeding fifty thousand baht or
both."
Section 57 The provisions of Section 119, Section 120 and Section 121 of the Medical Device Act B.E.
2551 shall be repealed and shall be replaced by the following: "Section 119 Anyone who does not give a
statement do not send necessary documents or evidence under Section 61 (5) without justification Shall
be liable to a fine not exceeding ten thousand baht.
Section 120. Any licensee, specifications provider or person having duties related to the manufacture,
import, sale or storage of medical device who does not assist a competent official under section 64 shall
be liable to imprisonment for a term not exceeding six months or a fine not exceeding ten thousand
baht, or both.
Section 121. Any establishment registrant, licensee or specifications provider who violates section 67
paragraph two shall be liable to imprisonment for a term not exceeding three years or a fine not
exceeding three hundred thousand baht, or both.
Section 122. In the case where an offender liable to a penalty under this Act is a juristic person, the
managing director, manager or person responsible for the operation of the juristic person shall also be
liable to the penalty provided for such an offence unless it can be proved that he/she did not connive at
or consented to the commission of the offence by such juristic person.
Section 58 The provisions of paragraph one of Section 123 of the Medical Device Act B.E. 2551 shall be
repealed and replaced by the following:
"Section 123, an offense under this Act which is punishable by a fine only, or an offense with
Imprisonment not more than one year The Secretary-General or the person assigned by the Secretary-
General shall have the power to compare the rules. As determined by the board And when the accused
has paid the fine according to the settled amount within thirty days From the date of comparison The
case is considered to be settled under the Criminal Procedure Code. "
Section 59 The fee rate annexed to the Medical Device Act B.E. 2551 shall be repealed and the fee rate
annexed to this Act shall be replaced
Section 60. All requests submitted on the day before the date this Act comes into force and are still
being considered shall be considered as requests under the Medical Device Act B.E. 2551 which is
amended by this Act and shall be processed further. According to the Medical Device Act B.E. 2551, as
amended by this Act In the case that any request is different from the rules under the Act Medical
Devices B.E. 2551, as amended by this Act The grantor has the power to order the applicant to The
request for action shall be in accordance with the Medical Device Act B.E. 2551, as amended by This act
Section 61. License or specifications declaration receipt issued under the Medical Device Act B.E. 2551
before the date this Act comes into force Will continue to be used until expiration
Section 62 Ministerial regulations or notifications issued under the Medical Device Act B.E. 2551 that
come into force on the day before the date this Act comes into force Shall continue to be used to the
extent that it does not conflict or contradict with Medical Device Act B.E. 2551, as amended by this Act,
until there are Ministerial Regulations or Notifications issued under the Medical Device Act B.E. 2551, as
amended By this Act coming into force
The issuance of ministerial regulations or notifications under paragraph one To be completed within two
years From the date this Act comes into force If unable to proceed To the Minister of Public Health
Report reasons that cannot be done to the Cabinet
Section 63 Announcement issued under the order of the Head of the National Council for Peace and
Order No. 7/2016 on the increase of efficiency in the process of granting health products dated 27
December B.E. 2559 in respect of medical devices Which is in force on the day before the date this Act
comes into force shall apply to Part 1 Medical Device Approval Process in Chapter 2 Establishment of
Registration Requesting and granting permission Notification of details and notification of the Medical
Device Act B.E. 2551, as amended by this Act Get as much as is not contrary or inconsistent with the
Medical Device Act B.E. 2551, as amended by this Act Until there are notices issued under the Medical
Device Act B.E. 2551, as amended by this Act
When the announcement issued under the Medical Device Act B.E. 2551 which was amended by this Act
comes into force The announcement issued under the order of the Head of the National Council for
Peace and Order No. 77/2016 on the increase of efficiency in the process of granting health products
dated 27 December B.E. 2559 in respect of medical devices shall be repealed
Section 64 The Minister of Public Health shall have charge and control of the execution of this Act.

Respondent of the Royal Command

General Prayut Chan-o-cha

The Prime Minister

Rate of charges

Production establishment Price per set 10,000 THB

registration certificate
Import registration certificate Price per set 20,000 THB
Medical device production Price per set 100,000 THB
license
Medical device import license Price per set 200,000 THB
Medical device sales license Price per set 10,000 THB
Medical device advertising Price per set 10,000 THB
license
Details of production of medical Price per set 50,000 THB
devices
Receipt of notification of details Price per set 100,000 THB
of imported medical devices
Notification form for producing Price per set 5,000 THB
medical device
Notification form for importing Price per set 10,000 THB
medical devices
Certificate Price per set 5,000 THB
Medical Device Assessment Price per set 2,000 THB
Certificate under Section 22
The substitute of establishment Price per set 500 THB
registration certificate, a
substitute for the certification
of medical device assessment
under Section 22, and a
substitute of the certificate
Establishment registration Price per set 100 THB
application
Application for license Price per set 1,000 THB
Details notification application Price per set 1,000 THB
Registration application Price per set 1,000 THB
Application for moving or Price per set 1,000 THB
changing the production place,
importing place, selling place, or
medical devices storage place
Application for lists on the Price per set 100 THB
establishment registration
Application for amendment of Price per set 1,000 THB
lists on the license or other
items as it is permitted
Application for the amendment Price per set 500 THB
on the lists in the details
notification document or other
items as it is notified
The renewal of the Price per set
establishment registration
equals to the fees for
establishment registration for
each copy
The renewal of the certificate Price per set
equals to the fee of each
certificate
 The renewal of the details
notification document equals to
the fee of each type of the
details notification document
The renewal of the medical Price per set 2,500 THB
devices production registration
certificate
The renewal of the medical Price per set 5,000 THB
devices import registration
certificate
Other applications Price per set 1,000 THB

In issuing ministerial regulations prescribing fees, the fees may be assigned differently, depending on the
type, group, type of medical device, size and business of the operator and the type of amendment.

Page 212
Book 136 Chapter 56Gor Government Gazette 30 April, 2019

Note: - The reason for promulgating this Act is because Thailand has entered into the ASEAN Agreement
on Medical Device Provisions. In addition to the Medical Device Act B.E. 2551, there are some provisions
that restrict the current operation of medical devices. It is appropriate to amend the control measures
for medical devices in accordance with the said agreement and to amend the limitation provisions. By
specifying a group of medical devices or medical devices according to the level of risk that may cause
danger or impact on public health and increase measures to control the production or import of medical
devices by notifying the reduction of the measure to control the export of medical devices, amended the
rules for the consideration of medical device consideration and related provisions to increase the
efficiency of the medical device approval process as well as amending penalties and fees as appropriate
and in line with current conditions. Therefore, this Act is needed to be enacted.