Presentation_Medical device registartion Malaysia.pdf

IDAMAZURA BINTI IDRIS
Registration, Licensing and Enforcement Division
MEDICAL DEVICE AUTHORITY
idamazura@mdb.gov.my

MEDICAL
DEVICE
REGISTER
Yes
Stop
Stop
No
No
No
Yes
Yes
Medical
device?
Classify the
medical device
Group the
medical
device
Approved
?
Assessment
by CAB
Conduct the
conformity
assessment
Apply for
registration
Pay fee
Evaluation
Decision

 Based on the definition of medical device
(Section 2 of Act 737).
 The purpose is to determine the jurisdiction
and the application of laws that control the
product.

SECTION 2 OF ACT 737
“Medical device” means any instrument, apparatus, implement,
machine, appliance, implant, in vitro reagent or calibrator,
software, material or other similar or related article:
a) intended by the manufacturer to be used, alone or in
combination, for human beings for one or more of the specific
purposes of:
(i) diagnosis, prevention, monitoring, treatment or alleviation of
disease;
(ii) diagnosis, monitoring, treatment, alleviation of or compensation
for an injury;
(iii) investigation, replacement, modification, or support of the
anatomy or of a physiological process;
(iv) supporting or sustaining life;
(v) control of conception;
(vi) disinfection of medical devices;
(vii) providing information for medical or diagnostic purposes by means
of in vitro examination of specimens derived from the human
body;
which does not achieve its primary intended action in or on the
human body by pharmacological, immunological or metabolic
means, but which may be assisted in its intended function by
such means
Ref: Section 2 of Act 737

b) any instrument, apparatus, implement, machine, appliance,
implant, in-vitro reagent or calibrator, software, material or
other similar or related article, to be used on the human body,
which the Minister may, after taking into consideration issues
of public safety, public health or public risk, declare to be a
medical device by order published in the Gazette
Ref: Section 2 of Act 737

“Medical device” means any instrument, apparatus, implement,
machine, appliance, implant, in vitro reagent or calibrator,
software, material or other similar or related article:
a) intended by the manufacturer to be used, alone or in
combination, for human beings for one or more of the specific
purposes of:
(i) diagnosis, prevention, monitoring, treatment or alleviation of
disease;
(ii) diagnosis, monitoring, treatment, alleviation of or compensation
for an injury;
(iii) investigation, replacement, modification, or support of the
anatomy or of a physiological process;
(iv) supporting or sustaining life;
(v) control of conception;
(vi) disinfection of medical devices;
(vii) providing information for medical or diagnostic purposes by means
of in vitro examination of specimens derived from the human
body;
which does not achieve its primary intended action in or on the
human body by pharmacological, immunological or metabolic
means, but which may be assisted in its intended function by
such means
Compliance with Act
737 & regulation

 The medical device need to be classified by the
Establishment (Specified in Section 3 of Act 737).
 It determines the degree of control and requirements
applicable to a device.
 It is based on the RISK associated to it at the point of usage.
 Factors influencing the classification;
 The duration of contact of the device with the body,
 The degree of and site of, invasiveness into the body,
 Whether the device deliver medicines or energy to the patient,
 Whether the device is intended to have a biological effect on
the body,
 Intended action on the body,
 Local vs systemic effects,
 Whether the device comes into contact with injured skin,
 Whether for diagnosis or treatment,
 The ability to be re-used or not,
 Combination of the device
Ref: file:///C:/Users/user/Downloads/MDA_GD04-classrules_%20First%20Edition_20%20Mac2014.pdf

 The classification of medical device is divided into 4
classes.
 The rules of classification is specified in 1st
Schedule of MD Regulation.
 16 rules to determine the class of general medical
device.
A
B
C
D
R I S K
Regulatory
control

Class Risk Level Device examples
A Low Simple surgical instruments, tongue depressor,
liquid-in-glass thermometer, examination light,
simple wound dressing, oxygen mask, stethoscopes,
walking aids
B Low-
Moderate
Hypodermic needles, suction equipment,
anesthetic breathing circuits, aspirator, external
bone growth simulators, hearing aids, hydrogel
dressings, patient controlled pain relief,
phototherapy unit, x-ray films
C High-
Moderate
Lung ventilator, orthopedic implants, baby
incubator, blood oxygenator, blood bag, contact
lens disinfecting/cleaning products, deep wound
dressing, defibrillator, radiological therapy
equipment, ventilator
D High Pacemakers and their leads, implantable
defibrillators, implantable infusion pumps, heart
valves, inter-uterine contraceptive devices,
neurological catheters, vascular prostheses, stents
Ref: 1st Schedule of MD Regulation

 Medical device shall be grouped based on Rules of
Grouping (Regulation 3(1)(b) of MD Regulation).
 The rules of medical device grouping are specified in
2nd Schedule of MD Regulation.
 3 basic rules to determine the grouping of the device;
 One generic proprietary name;
 One manufacturer;
 One common intended purpose.
Ref: file:///C:/Users/user/Downloads/5_MD_Grouping_(1).pdf

Ref: file:///C:/Users/user/Downloads/5_MD_Grouping_(1).pdf
grouping
for general
medical
device
Single
System Family
Set

Systematic examination of evidence
generated and procedures undertaken by the
manufacturer under the requirements
established by the Regulatory Authority to
determine that a medical device is safe and
performs as intended by the manufacturer
and, therefore, conforms to the Essential
Principles of Safety and Performance for
Medical Devices

What To Look For In Conformity Assessment?
Objective evidence for conformance to Essential
Principles of Safety & Performance of Medical
Device (EPSP) and other requirements specified
by the Authority
Who should do this?
Manufacturer of
medical device
What to be done?

 Medical devices shall be subjected to
conformity assessment to demonstrate
conformity to the requirements (Reg 4 of MD
Regulation).
 It is a responsibility of a manufacturer to
conduct conformity assessment in accordance
with requirements stipulated in 3rd Schedule
of MD Regulation 2012.
 The objective evidence must be collected and
examined depending on the class of medical
device.

 A product’s (medical device) conformity is
assessed by testing.
 A process’ conformity is assessed by audit.
 After conducting the assessment, objective
evidence are available to be collected and
examined.

 If the medical device is imported and the
manufacturer is not in Malaysia, he shall;
 Authorise an authorised representative
(AR) to act on behalf of him;
 Provide all evidence of conformity and
necessary support to the AR for the
purpose of conformity assessment.
Ref: Para 3(2), 10(1) and 10(2) of 3rd Schedule

 The elements are;
 Conformity assessment on quality
management system (QMS)
 Conformity assessment on post market
surveillance system (PMS)
 Conformity assessment on technical
documentation
 Declaration of conformity (DOC)
(Ref: Para 5(1) of 3rd Schedule)

 The manufacturer must establish, implement
and maintain a quality management system
(QMS) in accordance with the recognised
standard as determined by the Authority to
ensure good manufacturing practice of its
medical device.
 The extent of the QMS to be established,
maintained and implemented shall be
determined by the class of medical device.

Class QMS Appointment of CAB
Class A
medical
device
The manufacturer must
establish, implement and
maintain a QMS and may
exclude design &
development, process control
and inspection & testing
To verify evidence on
i. Securing & maintaining
sterile conditions
ii. Conformity of medical
device with the metrological
requirements
Class B
medical
device
maintain a QMS and may
exclude design &
development, process control
and inspection & testing
To review and conduct on-site
audit as it thinks fits to verify
evidence of compliance to the
requirements
Class C & D
medical
device
maintain a full QMS
To review and conduct on-site
audit to verify evidence of
compliance to the
requirements

 The manufacturer shall establish, implement
and maintain a post market surveillance
system as part of the QMS to ensure
continued conformity of its medical device to
the Essential Principles of Safety and
Performance (EPSP) through out the post
market stage.

Class Post Market Surveillance System (PMS)
Class A medical
device
Audit may be conducted on Post Market
Surveillance System to investigate specific safety
or regulatory concerns
Class B, C & D
medical device
Audit shall be conducted on Post Market
Surveillance System to ensure an appropriate
system is established, implemented and
maintained
 During the conduct of conformity assessment
by the CAB,

 The manufacturer shall
 collect and examine the evidence and
undertake procedures to determine
conformity of a medical device to the EPSP;
 Compile these evidence in a technical
documentation.
Ref: Para 8(1) and Appendix 1 of 3rd Schedule

Ref: Appendix 1 of 3rd Schedule
General Principles
Medical device should be designed &
manufactured in such a way that:
 no compromise to clinical condition or safety
of patients, or safety and health of users or
other persons
 control the risk so that residual risk is
brought down to an acceptable level
 suitable for one or more of the functions
within the scope of the definition of a
medical device
 characteristics and performances should not
be adversely affected to such a degree that
they compromise the health or safety of
patient or user and other persons during the
lifetime of the device
 characteristics and performances during their
intended use will not be adversely affected
under transport and storage conditions
 benefits must be determined to outweigh any
undesirable side effects
Design and Manufacturing Principles
 Chemical, physical and biological properties
 Infection and microbial contamination
 Manufacturing and environmental
properties
 Devices with a diagnostic or measuring
function
 Protection against radiation
 Requirements for medical devices
connected to or equipped with an energy
source
 Protection against mechanical risks
 Protection against the risks posed to the
patient by supplied energy or substances
 Protection against the risks posed to the
patient for devices for self-testing or self-
 administration
 Information supplied by manufacturer
 Performance evaluation including where
appropriate, clinical evaluation
Essential Principles of Safety & Performance of Medical Device

 The use of relevant standards is required to show
compliance to EPSP.
 Standards are established to provide;
 prescriptive specifications (eg. Device dimensions,
biomaterials, test or calibration procedures etc)
 performance specifications (eg. Strength
requirements, measurement accuracy, battery
capacity or maximum defibrillator energy)
 management specifications to set out
requirements for the processes and procedures to
be put in placed.
 These specifications address the specific
requirements of specific medical device in
relation to EPSP.

 The manufacturer shall establish a summary of
the technical documentation in the Common
Submission Dossier Template (CSDT) format.
 CSDT elements:
Ref: Para 8(2) and Appendix 2 of 3rd Schedule & GD on CSDT
 Executive Summary
 Relevant essential principles
and method used to
demonstrate conformity,
 Description of medical
device,
 Summary of design
verification and validation
documents,
 Pre clinical studies,
 Software validation,
 Medical device containing
biological material
 Clinical evidence,
 Use of existing bibliography,
 Medical device labeling,
 Risk analysis,
 Manufacturer information.

 The extent of information to be included in the
summary of the technical documentation shall be
determined by the class of medical device;
Class Summary Technical Documentation
(CSDT)
Review By CAB
Class A & B
medical
device
The manufacturer shall prepare the
summary technical documentation
and shall make it available upon
request and shall submit the summary
technical documentation to CAB.
The CAB shall review the
summary technical
documentation if the
submission is required.
Class C & D
medical
device
The manufacturer shall prepare and
submit the summary technical
documentation to the CAB
The CAB shall review the
summary technical
documentation to verify
conformity to the
requirements.

 A manufacturer must also attest and make a
declaration that the medical device is
conform to EPSP and other requirements
specified by the Authority.
 A manufacturer may use Declaration of
Conformity (DOC) template as appended in
Appendix 1A of 3rd Schedule of the
regulation.
Ref: Appendix 1A of Third Schedule

 Basic information to be provided in the DOC;
 Name & Address of Manufacturer,
 The declaration of conformity,
 Particulars of medical device,
 QMS certificate,
 Standard Applied.
 The DOC need to be printed out on the
manufacturer’s letterhead and sign by the
manufacturer.
 The DOC, supporting documents and certificates
and attestation shall be duly certified true copy
by the applicant.
Ref: Appendix 1A of Third Schedule

 The manufacturer must appoint a REGISTERED
Conformity Assessment Body (CAB) to carry out
conformity assessment on manufacturing
processes involved in producing the medical
device, post market surveillance system and
technical documentation.
 CAB will also review the Declaration of
Conformity (DoC).
 For imported medical device, the conformity
assessment is done by reviewing the evidence of
conformity provided by the foreign manufacturer
by the registered CAB appointed by the AR.

 The CAB shall conduct
the conformity
assessment in
accordance with the
requirements as
prescribed in Part III in
the 3rd Schedule of MD
Regulation 2012.
Ref: Para 3(3) of 3rd Schedule

 Upon completion of conformity assessment
and CAB is satisfied with the compliance to all
requirements, report of CA and a certificate
will be issued as evidence of compliance.
 The report of conformity assessment and its
certificate need to be submitted to the
Authority for the purpose of REGISTRATION.

 Upon completion of
conformity assessment
procedure, an
establishment may apply
for registration of medical
device in accordance with
the requirements and
procedures specified in
the MD regulation 2012.

 The requirements are stipulated in
 Medical Device Act 2012 (Act 737) –
 Section 6: Application for registration of
medical device
 Medical Device Regulation 2012 –
 Regulation 5: Application for registration

Who should apply
for registration?
Manufacturer (local
produced MD)
Authorised Representative
(AR) (imported MD)

 An application shall be made to the Authority in the
FORMs to be determined by the Authority [Reg. 5(1)].
 An application shall be accompanied with the
following:
a) Application fee as specified in the Fifth Schedule;
b) Document or information as specified in the
forms;
c) Other additional information, particulars,
document on application or sample of the medical
device [Reg. 5(2)];
 (c) shall be submitted within 90 days from the date
of request by the Authority [Reg. 5(3)]

 Application for medical device
registration can be made via a
computerized system called
MeDCASt.
 An on-line form can be accessed
from the web.
 The form is divided into 8 parts
(as shown in the diagram)
 Information & supporting
documents must be provided as
required in the form.
 Supporting document should be
in PDF format and the size
should not exceed 15MB
Medical Device Registration
Form
General Information on Medical
Device
Information on Manufacturer of
Medical Device
Grouping of Medical Device
Common Submission Dossier
Template (CSDT) and its supporting
documents
Post-Market Vigilance History
Declaration of Conformity
Attestation for Medical Device
Registration

Start
Request for
application fee
Paid?
Notify the receipt of
payment
Evaluate the application
and verify the documents
Satisfy?
Request for registration
fee
Paid?
Notify the receipt of
payment and register the
medical device
Return the application
to the applicant for
further information
End
Yes
Yes
Yes
No
No
No
*If the payment is not received within the specified time (30 working days)
Receive application &
notify the receipt of
application
*The
application will
be dropped
from the
system

Yes
Stop
Stop
No
No
No
Yes
Yes
Medical
device?
Classify the
medical device
Group the
medical
device
Approved
?
Assessment
by CAB
Conduct the
conformity
assessment
Apply for
registration
Pay fee
Evaluation
Decision
MEDICAL
DEVICE
REGISTER

After consideration and payment of
registration fee, the Authority may
REGISTER a medical device for a period
of 5 years, assign a registration number
and issue a certificate of registration.

Transition period is given for 2 years from
the appointed date (Section 80 (1) of Act
737)
Pending the determination the application
for medical device registration, an
establishment can continue their business
activities - import, export and placement
in the market (Section 80(3) of Act 737).

• Medical devices need to be registered before placement in
the market.
• Prior to that, medical device must undergo conformity
assessment to ensure its safety and performance.
• Evidence of conformity need to be compiled in CSDT
template and verified by REGISTERED CAB.
• If conformity assessment is satisfied, establishment can
apply registration of medical device via MeDC@St
accompanied with relevant fees, information and
supporting documents.
• Medical device will be registered if the Authority satisfy
with the submission.
• However, Transition & Saving Clause is given to facilitate
the compliance with Act 737 and its Regulation and also to
ensure the continuous accessibility of medical devices in
Malaysia market.

• Idamazura Idris @ Harun • Principal Assistant Director • Medical Device Registration Unit •
Registration, Licensing & Enforcement Unit • Medical Device Authority • Email: idamazura@mdb.gov.my

Presentation_Medical device registartion Malaysia.pdf

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