REPUBLIC OF KENYA

MINISTRY OF HEALTH

PHARMACY AND POISONS BOARD

GUIDELINES ON SUBMISSION OF DOCUMENTATION

FOR
REGISTRATION OF MEDICAL DEVICES

August 2017
Table of Content
 1. INTRODUCTION ............................................................................7

2. RISK BASED CLASSIFICATION FOR MEDICAL DEVICES ............13

3. REGISTRATION REQUIREMENTS OF A MEDICAL DEVICE. ............16

3.3 Local Authorized Representative and Subcontractors .....................20

4. Medical Devices Nomenclature ...............................................21

5. Related previous submissions ................................................21

6. Accessories ............................................................................21

7. Intended use..........................................................................22

8. Market history .......................................................................22

9. Sales, complaints and vigilance..............................................23

3.10Manufacturing process and subcontractors...................................23

3.11 User information ..........................................................................23

12. Design verification and validation ...............................................24

13. Risk management .......................................................................25

14. Clinical evaluation ......................................................................26

15. PMS and PMCF ..........................................................................27

16. Biological safety..........................................................................27

17. Sterilisation validation ................................................................27

3.20 Software ......................................................................................29

21. Packaging ...................................................................................30

22. Shelf life and stability testing......................................................30

23. Product lifetime ..........................................................................30

24. Animal derived substances .........................................................31

3.25 Grouping Requirements for medical Devices Registration .............31

4. MODULE 1 - LISTING OF CLASS A MEDICAL DEVICES ..................34

5. MODULE 2 - REGISTRATION OF CLASS B IVD MEDICAL DEVICES 36

5.1 Evaluation Routes 36

5.1.1 Full Evaluation Route (FER) 36

5.1.1.2 Abridged Evaluation Route (AER) 38

3. Expedited Class B Registration (EBR) Evaluation Route 39

6. MODULE 3 - REGISTRATION OF CLASS C AND D IVD MEDICAL DEVICES

41

Evaluation Routes 41

Full Evaluation Routes 41

Abridged Evaluation Route 42

Expedited Class C Registration (ECR) Evaluation Route 42

Expedited Class D Registration (EDR) Evaluation Route 43

TURN-AROUND-TIME (TAT) FOR PRODUCT REGISTRATION ..........45

7. PRODUCT REGISTRATION FEES .....................................................46

1. CHANGES TO A REGISTERED MEDICAL DEVICE ...........................47

2. AMENDMENT OF DEVICE LISTING .................................................48

3. SUSPENSION AND CANCELLATION OF REGISTRATION ..................49

List of Acronyms

CSTD- Common Submission Technical Dossier

IMDRF-International Medical Devices Regulators Forum( formerly Global
Harmonization Task Force)
STED-Summary Technical Documentation for Demonstrating Conformity to
the Essential Principles of Safety and Performance of Medical Devices

BSI-British Standard Institute

Annexes

ANNEX 1Letter of Authorisation Template ..................................

ANNEX 2 Marketing History Declaration Template (Class B) .......

ANNEX 3 Safety Declaration Template ........................................

ANNEX 4 Marketing History Declaration Template (Class C) .......

ANNEX 5 Risk Based Classification Of Medical Devices And Examples ( In-

Exaustive List)

ANNEX 6 sample of the essential principles conformity checklist

Tables

Table 1 Risk Based Classification Of Medical Devices And Examples

Table 2 Summary of the process followed after submission of application

Table 3:Types of marketing clearances or approvals from each country/region

Table 4 Summary Of Application Process To Be Followed For All Medical

Devices

Table 5 Summary of Submission Requirements for listing of (Class A)

Table 6 Summary of Submission Requirements (Class B) ..........

Table7 Summary of Submission Requirements (Class C and D) ..

Table 8 Turn-around-time (TAT) for medical devices registration

Table 9 Fees for registration of Medical Devices

Table 10 of Retention Fee’s for Medical Devices

1. INTRODUCTION

The Health Act 2017 and Health Products and Technologies (Medical Devices
including IVD Medical Devices) Regulations (Gazette Notice 35 2014) requires
evaluation and registration of medical devices, including In-Vitro Medical
Devices, prior marketing in Kenya.

This guidance document is meant to assist applicants in the registration of

medical devices under the Health Act 2017 and Gazette Notice No 35 2017.

Applicants are strongly encouraged to familiarize themselves with the criteria

and requirements for review processes outlined in this guidance and the other
relevant guidance documents before submitting their applications. Incomplete
submissions and untimely responses to queries will result in unnecessary
delays to the registration process and thus, will have a negative impact on the
target processing timelines. Applications with the incorrect risk classification of
devices may result in the re-submission of the applications according to the
appropriate risk class.

Applicants are reminded that, notwithstanding the registration of a medical

device under the Health Act, the supply and use of any medical device
including In-Vitro Diagnostic Medical Devices in Kenya should also comply
with the requirements under other applicable legislations (e.g. Radiation
Protection Act).

If there are any contradiction between the guidance documents and any written
law, the latter shall take precedence.

This guidance should be read together with the other relevant guidance
documents.

1. Scope
This guidance document describes the processes and general requirements for
the submission of an application for a new medical devices and Invitro
diagnostics Registration.

1) These guidelines shall apply to medical devices and their accessories.

2) Where a device is intended to administer a medicinal product, that device

shall be governed by this guideline, without prejudice to the corresponding
regulations for registration of medicinal products for human and veterinary use
set by the PPB.

3) Where a device incorporates, as an integral part, a substance which, if used

separately, may be considered to be a medicinal product and which is liable to
act upon the body with action ancillary to that of the device, that device must
be assessed and authorized in accordance with this guideline.
2. Definitions
Definitions that do not indicate they are set out in the health Act 2017 or
Regulations are intended as guidance in this document. These definitions are
not taken verbatim from the above-mentioned legislation and should not be
used in any legal context. These definitions are meant to provide guidance in
layman terms.

APPLICANT: for the purposes of this guidance document, an Applicant is the

person applying for a medical device registration.

INTENDED USE: for the purposes of this guidance document, means the
objective intended use or purpose, as reflected in the specifications,
instructions and information provided by the medical device owner of the
medical device.

LABEL: in relation to a health product, means any written, printed or graphic

representation that appears on or is attached to the health product or active
ingredient or any part of its packaging, and includes any informational sheet or
leaflet that accompanies the health product or active ingredient when it is
being supplied.

Medical device’ means any instrument, apparatus, implement, machine,

appliance, implant, reagent for in vitro use, software, material or other similar
or related article, intended by the manufacturer to be used, alone or in
combination, for human beings, for one or more of the specific medical
purpose(s) of:
a.diagnosis, prevention, monitoring, treatment or alleviation of disease,
b.diagnosis, monitoring, treatment, alleviation of or compensation for an injury,
c.investigation, replacement, modification, or support of the anatomy or of a
physiological process,
a) supporting or sustaining life,
b) control of conception,
c) disinfection of medical devices,
d) providing information by means of in vitro examination of
specimens derived from the human body;
 e) disinfection substances,
f) aids for persons with disabilities,
g) devices incorporating animal and/or human tissues,
h) devices for in-vitro fertilization or assisted reproduction
technologies.
and does not achieve its primary intended action by pharmacological,
immunological or metabolic means, in or on the human body, but which may be
assisted in its intended function by such means.
In-Vitro Diagnostics Medical Device (IVD-MD) means a medical device,
whether used alone or in combination, intended by the manufacturer for the in
vitro examination of specimens derived from the human body solely or
principally to provide information for diagnostic, monitoring or compatibility
purposes.

Manufacturer
6.1) Means the natural or legal person with responsibility for the design,
manufacture,packaging and labelling of a device before it is placed on the
market under his own name, regardless of whether these operations are carried
out by that person her/himself or on her/his behalf by a third party.
6.2) The obligations of this guideline to be met by manufacturers also apply to
the natural or legal person who assembles, packages, processes, fully
refurbishes and/or labels one or more ready-made products and/or assigns to
them their intended purpose as a device with a view to their being placed on
the market under his own name.
PRODUCT OWNER (Market Authorization Holder): for the purposes of this
guidance document, means a person who sells a medical device under his own
name, or under a trade-mark, design, trade name or other name or mark
owned or controlled by the person, and who is responsible for one or more of
the following activities:-designing, manufacturing, assembling, processing,
labelling, packaging, refurbishing or modifying the device, or for assigning to it
a purpose, whether those tasks are performed by that person or on his behalf.

Serious Deterioration in the state of Health

: in relation to a person, means —

• a life-threatening illness or injury suffered by that person;

• a permanent impairment of a bodily function of that person;

• any permanent damage to any part of that person’s body; or

a condition requiring medical or surgical intervention to prevent any such

permanent impairment or damage.

Accessory
Means an article which whilstnotbeing a device is intended specifically by its
manufacturertobeusedtogetherwithadevicetoenableittobe used in
accordancewiththeuseofthedeviceintendedbythemanufacturerofthe device

Local Authorized Representative

7.1) Any manufacturer based outside the Kenya must designate a local authorized
representative (LAR). The appointed LAR must provide written evidence that
they are acting with the consent of a manufacturer located outside the Kenya.
7.2) The responsibility of the LAR is, to assure regulatory compliance and serve as
the central communication pathway with the PPB

Risk: Combination of the probability of occurrence of harm and the severity of

that harm.
Universal Medical Device Nomenclature System (UMDNS)- A system used to
facilitae identifying, processing, filing, storing, retrieval, transferring, and
communicating data about about Medical Devices. UMDNS Includes all
Medical Devices and Supplies, clinical laboratory Equipemtn and IVD’s,
Genertic Tests, Medical Software related to Devices, Selected Hospital
Furniture, Systems and Test Equipments, as well as personal and assistive
devices.
Unique Device Identification (UDI)- A series of Numeric or alphanumeric
characters that is created through a coding system. It allows the unambigious
idnetification of a specific product on the Market and represents the ‘access
Key’ to Device related information stored in the UDI data. The UDI comprises
the Device Identifier and Production Identifier.
Global Medical Devices Nomenclature (GMDN) – A Poly-Hierarchical system of
identifying Medical Devices into collective Terms which give a Device attribute
and high Level terms allowing analysis of the Device by Product attribute or
Feature.
Non-Invasive Medical Devices- A device which in whole or in part does not
penetrate the body, either through a body orifice or through the surgace of
the body.
Invasive Medical Devices- The Definition for Which refers to;

• Invasive device: A device, which, in whole or in part, penetrates

inside the body, either through a body orifice or through the
surface of the body. 
 • Body orifice: Any natural opening in the body, as well as the
external surface of the eyeball, or any permanent artificial opening,
such as a stoma or permanent tracheotomy.

• Surgically invasive device: An invasive device which penetrates

inside the body through the surface of the body, with the aid or in
the context of a surgical operation.

Active Medical Devices- any  medical device  relying for its functioning on a
source of electrical energy or any source of power other than that directly
generated by the human body or gravity and which acts by converting this
energy

1.1 Reference Regulatory Authority

1. Australia Therapeutic Goods Administration (TGA) Device Registration
Licence

2. Health Canada (HC) Device Registration Licence

3. Japan Ministry of Health, Labour and Welfare (MHLW)

-Pre-MarketCertification from a Japanese Registered Certification Body

-Pre-Market Approval from MHLW

4. US Food and Drug Administration (US FDA)

-510K clearance
-Premarket Approval (PMA)
5. European Union Notified Bodies (EU NB) via EC certificates issued
according to

-Directive 93/42/EEC Annex II section 3 or Annex V for Class IIA devices

-Directive 98/79/EC Annex IV or Annex V with Annex VII for List B and self-
testing IVDs
6. Irish Health Products Regulatory Authority
7. Swiss Medic
8. Saudi Arabia Food and Drug Authority (SFDA)

2. RISK BASED CLASSIFICATION FOR MEDICAL DEVICES

The inherent risk of a medical device depends substantially on its intended
purpose and the effectiveness of the risk management techniques applied
during design, manufacture and use.

Other considerations in risk classification include its intended user(s), its mode
of operation and the technology used. Examples of factors influencing risk
classification include the duration of medical device contact with the body, the
degree of invasiveness, whether the medical device delivers medicinal products
or energy to the patient, whether they are intended to have a biological effect
on the patient and local versus systemic effects, etc. Ref to Annex 5; Risk
Based Classification Of Medical Devices And Examples ( In-Exaustive List)

Table 1 Risk Based Classification Of Medical Devices And Examples

CLASS RISK LEVEL EXAMPLES

• Cotton wool, bandages,urine collection
bottles; compression hosiery; non-invasive
electrodes, hospital beds.
A Low Risk
➢ urinary catheters, tracheal tubes.
➢ Orthodontic materials, removable dental
Low- prosthesis
B moderate
➢ urethral stent; contact lenses for long-term
continuous use
Moderate- ➢ catheter containing sealed radioisotopes
C high
• Pacemakers; Implantable defibrillators.

• prosthetic heart valves; cardiovascular stents;

pacemaker leads and electrodes; deep brain
stimulation electrodes; cerebrospinal
catheter.
D High Risk

Medical devices vary greatly in complexity and application. Examples range

from simple devices such as  tongue depressors,  medical thermometers,
and disposable gloves to advanced devices such as computers which assist in
the conduct of medical testing, implants including those used for contraception
and prostheses. The design of medical devices constitutes a major segment of
the field of biomedical engineering.
For the purpose of this guidance document, the rules applied for the risk based
classification of Medical devices are as below;
1. Non-Invasive Medical Devices

2. Invasive Medical Devices- The Definition for Which refers to

• Invasive device: A device, which, in whole or in part, penetrates

inside the body, either through a body orifice or through the
surface of the body. 

• Body orifice: Any natural opening in the body, as well as the

external surface of the eyeball, or any permanent artificial opening,
such as a stoma or permanent tracheotomy.

• Surgically invasive device: An invasive device which penetrates

inside the body through the surface of the body, with the aid or in
the context of a surgical operation.

3. Active Medical Devices

➢ Considerations to be made

Risk Based Classification:

• The level of regulatory requirements increases as the levels of the device

risk class increases. These regulatory controls may include, for example:

• Operation of a quality system (recommended for all devices);

• technical data;

• Product testing using in-house or independent resources;

• Documentation of clinical evidence to support the manufacturer’s claims;

• The need for and frequency of independent external audit of the

manufacturer’s quality system; and

• Independent external review of the manufacturer’s technical data.

4.Exeptional Classes

• Medical Devices which Incorporate Medicinal Substances

• Devices manufactured from or incorporate non-viable animal tissues or

their derivatives

• Medical Devices- used for sterilizing or Disinfecting Medical Devices

• Medical Devices Incorporating Animal or Human Cells/Tissues/

Derivatives

• Medical Devices for Ophthalmic Solutions Use

• Medical Devices for Contraception or the prevention of Sexually

Transmitted Diseases’ (STD’s)

• Implantable Medical Devices for Long-term Use

5. MORE THAN ONE CLASS

• Where a medical device has features that place it into more than one
class, classification and conformity assessment should be based on
the highest class indicated.

• The actual classification of a Medical Device is determined by the

Manufacturer and on its intended use.

3. REGISTRATION REQUIREMENTS OF A MEDICAL DEVICE.

This document aims to provide guidance on the preparation of a product
registration application for general medical devices using the Common
Submission Dossier Template (CSDT). In particular, this document serves to
clarify the information to be submitted in each section of the CSDT and the
format that this information is to be submitted in.

The CSDT document contains elements of the International Medical Devices

Regulators Forum(IMDRF) guidance document titled “Summary Technical
Documentation for Demonstrating Conformity to the Essential Principles of
Safety and Performance of Medical Devices (STED)”.

Product registration applications for medical devices submitted to PPB must be

prepared in the format set out in the CSDT document
Regulatory controls for medical devices are according to the inherent of risks
associated with the medical devices. All medical devices including in vitro
diagnostic medical devices must be registered with PPB prior to placing them
on the Kenya market unless exempted by the Regulations

3.1 The Common Submission Technical Dossier (CSTD )Format of

Submitting an application for Medical Devices

3.1.1Along with the list of configurations of medical devices to be registered;

3.1.2 The Common Submission Dossier Template (CSDT) will have the
following components to be provided by the applicant depending on the class of
the Medical device applied for;

3.1.2.1Executive Summary
An executive summary shall be provided with the common submission dossier
template, which shall include the following information:
• an overview, e.g., introductory descriptive information on the medical
device, the intended uses and indications for use of the medical device,
any novel features and a synopsis of the content of the CSDT;
• commercial marketing history;
• intended uses and indications in labelling;
• list of regulatory approval or marketing clearance obtained.
• status of any pending request for market clearance; and
• important safety/performance related information

3.1.2.2Essential Principles Checklist and Declaration of Conformity –

The evidence of conformity can be provided in tabular form with supporting
documentation available for review as required. a completed Essential
Principles conformity checklist can be used to demonstrate that a recognized
test standard was used as part of the method to demonstrate conformity to one
Essential Principle. As such, CSDT would then include a declaration of
conformity to the standard, or other certification permitted by the Regulatory
Authority, and a summary of the test data, if the standard does not include
performance requirements. When the manufacturer uses international or other
standards to demonstrate conformity with the Essential Principles, the CSDT
should identify the full title of the standard, identifying numbers, date of the
standard, and the organization that created the standard. When the
manufacturer uses other means, such as internal standards, the CSDT should
describe the means. Not all the essential principles will apply to all devices and
it is for the manufacturer of the device to assess which are appropriate for his
particular device product. In determining this, account must be taken of the
intended purpose of the device.

Not all the essential principles will apply to all devices and it is for the
manufacturer of the device to assess which are appropriate for his particular
device product. In determining this, account must be taken of the intended
purpose of the device.

Refer to annex 5 for an example of a safety conformity assessment form

3.1.2.3Device Description
Besides a general description of the device, a more detailed description of the
device attributes is necessary to explain how the device functions, the basic
scientific concepts that form the fundamentals for the device, the component
materials and accessories used in its principles of operation as well as
packaging. A complete description of each functional component, material or
ingredient of the device should be provided, with labelled pictorial
representation of the device in the form of diagrams, photographs or drawings,
as appropriate.

Pictures and schematics should be provided wherever possible to enable an

understanding of the device design features and intended purpose.

3.1.2.4Detailed Information of Design Verification and Validation

Documents
Full reports of Preclinical Studies including the detailed sterilisation
validation and shelf life studies if applicable
Clinical Evidence – Clinical Evaluation Report including publications and full
reports of the studies referenced in the clinical evaluation report.

3.1.2.5Proposed Device Labelling

This is the descriptive and informational product literature that accompanies
the device any time while it is held for sale or shipped. This section should
summarize or reference or contain the following labelling data to the extent
appropriate to the complexity and risk class of the device, which is generally
considered as “labelling”:
• Labels on the device and its packaging;
• Instructions for use;
• Physician’s manual
• Any information and instructions given to the patient, including instructions
for any procedure the patient is expected to perform (if applicable).

3.1.2.6Risk Analysis
This section should summarize or reference or contain the results of the risk
analysis. This risk analysis should be based upon international or other
recognized standards, and be appropriate to the complexity and risk class of
the device. 4.5.1 Results of Risk Analysis A list of possible hazards for these
devices must be prepared. Indirect risks from medical devices may result from
device-associated hazards, such as moving parts, which lead to sustained
injury, or from user-related hazards, such as ionizing radiation from an X-ray
machine. The evaluation of these risks against the claimed benefits of the
device and the method(s) used to reduce risk to acceptable levels must be
described. The individual or organization that carries out the risk analysis
must be clearly identified. The technique used to analyze risk must be
specified, to ensure that it is appropriate for the medical device and the risk
involved.

3.1.2.7Manufacturer Information

-Name and address of the manufacturing site(s)

-Proof of Quality Management System – e.g. ISO13485 Certificate, Conformity
to US FDA Quality System Regulations or Japan MHLW Ordinance 169
-Manufacturing Process - Flow Chart

For medical device with intended use beyond the inherent performance of the
device, additional clinical data may be requested to substantiate the proposed
label use.

Table 3:Types of marketing clearances or approvals from each country/

region

Country/Region Approval Type

Australia Australia Therapeutic Goods Administration (TGA)
licence
Canada Health Canada Licence
European Union For General Medical Devices
(EU) -Annex II Section 3 or Annex V of MDD (for Class IIA)
-Annex II Section 3 or Annex III coupled with Annex V of
MDD (for Class IIB)
-Annex II Section 3 and 4 of MDD (for Class III)
-Annex II Section 3 and 4 of AIMDD (for active
implantable medical devices)
For IVD
ANNEX IV (including Section 4 and 6) of IVDD (for List A
IVD) • Annex IV (excluding Section 4 and 6) or Annex V
coupled with Annex VII of IVDD (for List B and selftesting
IVD)
Japan Ministry of Health, Labour and Welfare (MHLW) Licence
United States of US FDA 510(K) clearance letter [510(K) exempted
America (USA) products do not qualify for abridged evaluation route.]; or
• US FDA PMA approval letter

3.3 Local Authorized Representative and Subcontractors

7.1) Any manufacturer based outside the Kenya must designate a local
authorized

representative (LAR). The appointed LAR must provide written evidence that

they are acting with the consent of a manufacturer located outside the Kenya.

7.2) The responsibility of the LAR is, to assure regulatory compliance and
serve as the

central communication pathway with the PPB

7.3) Local Authorized Representative roles include

a) Acting as primary contact point with the competent authority ;

b) Keeping technical file documentation ready and available for the Competent
Authority;
c) Protecting documentation confidentiality because they are authorized to
show them to the Competent Authorities only;

d) Notification of Adverse Event and Incident Reporting to the Competent

Authorities;

e) Assurance of supply chain regulatory compliance and accountability of

medical devices;

f) Product Safety Vigilance reporting;

g) Field Safety Corrective Action implementation, management, coordination

and reporting;

h) Assistance with technical file documentation;

i) Annual review of your technical file;

j) Notification of changes and amendments to the Medical Device regulations

that affect the device(s).

3.4. Medical Devices Nomenclature

Several existing Nomenclatures for medical devices will be recognized by the

Pharmacy and Poisons Board. This include the Universal MedicaL Device
Nomenclature System (UMDNS), the Unique Devices Identification (UDI) and the
Global Medical Devices Nomenclature(GMDN) Depending on the nomenclature
used in the jurisdiction where the submitted application for a medical device is
being made.

3.5. Related previous submissions

Details of any other submissions relevant to the application, such a previous
submissions and all outcomes from such reviews.

3.6. Accessories
The following information should be provided for any accessories (including
Class A) associated with the device:

i. Brief description of the accessory/ accessories and how they are used
with the device(s)

ii. Classification of the accessories and rationale for classification

 iii. Technical Documentation references

iv. Please note the Technical Documentation of the main machine/

equipment should demonstrate compatibility of the devices with any
applicable accessories.

3.7. Intended use

The intended use should provide sufficient detail to explain the disease
conditions the device is intended to treat or monitor, the basic principles of
operation (ie intended users and environment), the intended patient population
and the indications and contraindications of the device.

i. Indications and contraindications should be supported by objective

evidence (eg, evidence provided in the risk assessment and clinical
evaluation reports).

ii. The intended use must include use of the device as a “medical device” as
defined by Article 1 of the respective Directives unless this is otherwise
justified.

iii. Please ensure the intended use been described consistently throughout
the file (eg. in the IFU, risk management documentation, clinical
evaluation report, and design requirements).

iv. If the application includes a change to the intended use, all sections of
the file should be reviewed for potential impact.

v. For clarity it is suggested that this should be separate from the device
description.

3.8. Market history

All submissions should be accompanied by a market history to enable an
understanding of the context of device development.

• If the device is new and has never been marketed by the manufacturer
anywhere in the world, please state this explicitly.
• For existing devices:
Ensure that a market history is provided indicating the nature and timing
of any changes and that any associated documents (i.e. risk analyses,
 labelling, clinical evaluation reports, verification/ validation data, etc.)
account for these changes.

3.9. Sales, complaints and vigilance

Please provide sales, complaints and vigilance data for the last 5 years
for your device, if available.

• Sales and complaints data should include sales outside the country of
Origin/ Manufacturer. A breakdown should be provided to enable
evaluation of sales and complaints by region.
• Complaints data should be evaluated rather than just listed. For
example, why is the complaints rate considered acceptable? Have any
trends been noted, or corrective actions taken? What is the status of
these actions?
• Full details of vigilance issues should be provided, including the status
of any Field Safety Corrective Actions or Notices.

3.10Manufacturing process and subcontractors

A detailed overview of the manufacturing processes should be provided. This
should clearly identify any special or proprietary processes, and any
subcontracted processes.
The name and location of key manufacturing subcontractors should be
provided.
If new key subcontractors are used, provide copies of their ISO 13485
certificates.Validation documents for processes that can affect final product
quality should be provided.

3.11 User information

Documents may include labels, instructions for use (IFU), patient implant
cards, surgical manuals, brochures, marketing literature, etc
Legible versions of all levels of labels should be provided (e.g. secondary pack,
primary pack) and should be representative of the finished form, showing all
included symbols.
It is sufficient to show information concerning labelling in English only, but
items to be translated and the plan for translation should be indicated.
If possible, provide drawings with the packaging configuration (showing
placement of all labels) and label specifications.
The position of labels on the finished product should be clear. If any of the
packaging is printed with information for the user (including pictures/
schematics of the device) this should also be provided. It should be clear how
the labelling documents are controlled.
Supporting evidence should be provided for any claims made in the labelling or
marketing literature.
Please ensure that any specific requirements of relevant harmonized standards
are addressed in the labels and information for use.

12. Design verification and validation

Product design specifications should be adequately documented, outlining the
key functional characteristics and technical performance specifications for
each device, along with verification/ validation tests to substantiate that they
have been achieved.

Overall, manufacturers should demonstrate that design requirements have

been identified in accordance with the intended use, safety and performance
requirements, risk assessments, and relevant harmonised and other key
standards.

To this end, the source of design requirements should be indicated. Although

compliance to harmonised and other key standards is expected, please be
aware that testing beyond that required by the standards may be necessary to
demonstrate compliance of your device to the relevant Essential Requirements.
Design requirements should be mapped to the intended use, performance and
risks identified for the device.

A design verification/ validation strategy document and/ or summary of the

outcomes should be provided. Verification/ validation results should be
provided for each design requirement. If compliance has been demonstrated
without testing, an appropriate rationale should be provided.

Test reports should document objectives, acceptance criteria, materials &

methods, results, protocol deviations, and conclusions.

• If test results are considered representative for a group of devices (i.e. worst
case devices or comparative devices), then a justification for leveraging
protocol(s) and report(s) should be provided.
• Similarly, if testing has been undertaken on prototypes or devices that
otherwise do not represent the finished goods, a justification for the adequacy of
this testing should be provided.
• If multiple design verification / validation studies were conducted please
provide a flow chart or table that shows how the studies were conducted and
 highlight which study ultimately demonstrates that the design meets the
product performance specifications.
• For line extensions or devices based on “existing” devices, it may be possible to
leverage data from testing undertaken on the existing devices. In this case, a
rationale for the use of existing data must be provided, including:
• Evidence of equivalence to the comparative devices – a table showing the
similarities and differences greatly speeds the review process. Key things to
consider include (but may not be limited to):
➢ materials of construction

➢ indications for use

➢ methods of manufacturing

➢ key design features

An evaluation of the impact of any differences on clinical safety, performance,

and testing undertaken. The evaluation should support the conclusion that the
new devices do not represent a worst case in terms of testing as compared to
the devices tested.

13. Risk management

A thorough design, clinical and process Risk Management assessment should
be conducted for the entire life-cycle of the device (from initial design concept
up to and including device disposal). This should be updated (as appropriate)
with data from PMS.

• The risk management documentation should provide a template for

preparedness, indicating whether controls (i.e. process validations,
biocompatibility, sterilisation, clinical, shelf-life or other key verification /
validation tests) have reduced all risks as low as possible (vs. as low as
reasonably practicable) to acceptable levels in light of state-of-the-art for the
product(s) under review.
• The assessment must demonstrate that the benefits outweigh all the
residual risks when the device is used as intended.
• The analysis must demonstrate that appropriate controls (design out
then protective measures) have been applied to all risks.
• Information for use may reduce occurrence of some risks, but it cannot
reduce the occurrence of residual risks. Please ensure appropriate use
and quantification of risk control measures in the risk assessment.
 • A copy of Risk Management Procedure(s) that include the definition of
any rating systems used for risk analysis and risk acceptability should
be provided.
For line extensions and devices based upon existing devices, the
manufacturer may conclude that pre-existing risk management
documentation is applicable. However, there are always risks associated
with even small changes, and a summary to demonstrate that these risks
have been considered (and have been adequately mitigated) should be
provided.

14. Clinical evaluation

Clinical evaluations are required for all medical devices.

• It is useful to provide a copy of the procedure for conducting Clinical

Evaluation.
• If a pre-market clinical investigation has been conducted, please ensure:
- appropriate documentation (CIP, letter of “no objection” from the
Competent Authority, evidence of Ethics approval, final report, etc) is
provided;
- the final clinical trial protocol agrees with that submitted to the
Competent Authority, and evidence that any deviations have been
agreed with the CA has been provided;
- the final report demonstrates that requirements for all safety and
performance endpoints have been met;
- there are no open clinical investigations relevant to your devices with
endpoints related to safety or performance claims.
• Representative clinical data must be provided for all indications and
variants. Justifications for why one group of data is representative of
another must be clearly substantiated.
• If no clinical investigation data is available for the subject device and the
Clinical Evaluation relies on a justification of equivalence of comparative
devices, the justification must identify and discuss the potential clinical
impact of all differences between the subject and comparable devices
relative to intended use, technical, or biological factors.
• A justification should be provided (with appropriate evidence) to
substantiate the qualifications of individual(s) conducting/
approving the clinical evaluation.
• Some indications or specific clinical benefit claims may require the
Notified Body to consult with an external expert (a surgeon or
 similar). Contracting a confidential source that is mutually agreed
with the Manufacturer may be time consuming.

15. PMS and PMCF

A Post-marketing Surveillance Plan (PMS Plan) commensurate with the
product risk, lifetime, and available clinical data should be provided for
each device/ device family.

1. Ensure that the PMS plan adequately justifies the monitoring of

the safety and intended performance of the device.
2. If Post-Market Clinical Follow-up (PMCF) is not part of the PMS
Plan,
3. please ensure that adequate justification is provided, based on the
risk and clinical data available for the device.
4. A copy of the Post Market Surveillance procedure should also be
provided. Please note that the procedure is not the same as the
Plan – the former refers to the manufacturer’s quality system
5. requirements and is generic to all devices marketed by a
manufacturer, whereas the latter is specific to the subject device,
and can only be generated in light of data from the clinical
evaluation and risk evaluation for that device.

16. Biological safety

• Biological safety assessments should be undertaken in accordance
with ISO 10993-1. See Clause 7 of this standard for guidance with
respect to appropriate report content.
• Link to ISO 10993-1 https://www.iso.org/standard/44908.html
• Biocompatibility assessments should include evidence of compliance for
the finished device (including consideration of all materials and all
manufacturing steps). It is not sufficient to simply state that devices
have been manufactured.

17. Sterilisation validation

Sterilisation validation is reviewed separately.

• Appropriate rationales are required if sterilization validation is by

adoption into an existing family or sterilisation validation.
 • Devices for End-User-Sterilisation also require review of cleaning
and sterilisation validation/ adoption with respect to parameters
recommended in the IFU.
• Documents should describe:
- use of “State of the art” process validation methods;
- the bioburden controls and monitoring;
- the product qualification (Dose verification, BI suitability testing,
SAL calculations);
- the process qualification (Performance qualification, Dose Map, BI
Inactivations).
Additional guidance relating to specific document types is provided below:

3.18 Shelf Life Validation should include:

• Protocol (with acceptance criteria for each test performed) and

appropriate test references;
• A clear statement of the intended shelf life;
• A clear statement defining the sterilization status of the test samples
(1X, 2X sterilized);
• A summary of the accelerated aging parameters (temperature and
humidity) and how the aging times were calculated;
• A statement covering Real Time Aging plans;
• A clear delineation of statistically significant sample quantities;
• Actual physical/microbiological test data reports supporting the
expiration date, or post aging, claim (peel testing, burst testing, dye
testing, etc);
• A summary of the ship testing/ transit simulation testing conducted
and applicable test reports.

3.19 Sterilization Validation – Radiation should include:

• Protocol;
• Dosimetry mapping data (typically from the sterilization contractor);
• Validation of bioburden testing method & test report;
• Bioburden determination & test reports;
• Calculation or determination of verification dose and full dose;
• Validation of product sterility testing method & test report;
• Sterility testing of verification dose samples & test report.
•
3.20 Software
Appropriate documentation is required if the medical devices are either stand-
alone software or rely upon software.

If medical device is stand-alone software, guidance for the qualification and

classification of the software is found in MEDDEV 2.1/6. See Attachment B for
a link to this guidance.

There should be a rationale for why the software is a medical device and for its
classification. If applicable, the software should be broken down into modules,
some that have a medical purpose and some that do not. The modules with a
medical purpose must comply with the requirements of the Medical Device
Directives and must carry the CE marking. The non-medical device modules
are not subject to the requirements for medical devices.

Ensure all relevant harmonised and non-harmonised software standards have

been considered. Ensure the software systems/ modules/ items have been
assigned safety classifications based on standards.

Include documentation on the medical device software life-cycle processes

implemented (e.g. software design/ development, maintenance/ change
management, risk management, configuration management, problem
resolution, verification, and validation processes).

Include software development process documentation (e.g. software

development plan, software requirements specification, software architecture,
software detailed design, software unit testing procedures/ reports, software
integration testing procedures/reports, and software system testing) and
maintenance process documentation (e.g. software maintenance plan). Note:
Some documentation may or may not be required per the standards based on
software system/ module/ item risk classification.

Include software risk assessment documentation (e.g. software hazard

analysis, software failure mode and effects analysis, fault tree analysis,
traceability). Note: Some documentation may or may not be required per the
standards based on software system/ module/ item risk classification.

Instructions for use that detail the validated sterilization and cleaning
parameters. Please be aware that reference to “standard hospital practice” is
insufficient;

Validation report for the sterilization parameters listed in the IFU;

Validation report for the cleaning parameters listing in the IFU.

21. Packaging
Packaging testing should address requirements for both transit endurance and
shelf life stability, and be undertaken in accordance with relevant standards.

A complete packaging BoM and diagrams should be provided to illustrate how

each device is packaged.

If all packaging configurations/ device combinations have not been tested, a

rationale based on worst case (ie heaviest and lightest devices, sharp or pointy
edges, etc) should be provided.

Any change to packaging is considered a significant change. For Class III

devices, these must be reported to BSI for review and certificate re-issue.

22. Shelf life and stability testing

Shelf life is normally considered to be the time the device can be kept in the
packaging prior to use. This is not the same as “Lifetime”.

Shelf-life testing is not restricted to the packaging. The device itself should be
subject to shelf life testing, or a rationale provided to demonstrate why its
characteristics are not expected to degrade over the claimed shelf life.

If shelf life testing is based on accelerated age testing, this should be

accompanied by a plan for real time testing. Real time testing should be
underway by the time documentation is submitted for review.

23. Product lifetime

The lifetime of the device should be defined, and considered relative to other
parts of the dossier (e.g. risk management, clinical evaluation, PMS). Product
lifetime is normally considered as the time from manufacture until the device
ceases to fulfil its intended use. This is not the same as “Shelf Life”.

Medicinal substances/Human blood derivative & recombinant protein/

peptides. The submission should clearly indicate whether or not the device
contains any medicinal substances and /or human blood derivatives and/ or
recombinant peptides/proteins. Full justification on the primary mode of action
of the device and evidence that the above components are ancillary should be
provided.

Devices which incorporate, as an integral part, an ancillary medicinal

substance or an ancillary human blood derivative or ancillary recombinant
protein/ peptide are subject to requirements of additional European
Directives/ Regulations.

Additional review resources will be required, and under the amending Directive
2007/47/EC, a consultation with one of the Competent Bodies established
under Directive 2001/83/EC or EMA (The European Medicines Agency) is
required. Information on the medicinal substance (ASMF, if available) or an
ancillary human blood derivative (PMF) or ancillary recombinant protein/
peptide itself and as incorporated in the device should be submitted.

24. Animal derived substances

The submission should clearly indicate whether or not the device utilizes, or is
used in conjunction with, any materials of animal origin.

Manufacturing subcontractors should be consulted if appropriate to establish

if any such substances are used during manufacture, even if they do not
feature in the final device (eg lubricants or mould release agents which may
use animal derived substances).

Devices which incorporate materials from TSE-susceptible species will be

subject to stricter requirements and the conformity assessment route will
require Competent Authority consultation.

3.25 Grouping Requirements for medical Devices Registration

Medical devices that can be grouped into one of the grouping categories can be
submitted in one product registration application. The listed groups below are
an example of groupings for medical devices registration.

However, devices with different proprietary names or brand names will be listed
separately under different device application.

Existing regulatory requirements apply to all medical devices to be registered,

regardless of the manner in which they are grouped for product registration
submission. Information on all medical devices within a grouping must be
submitted as part of the dossier/application for registration, such as
authorisation from all medical device product owners for registration and data
to substantiate the performance of these devices.

Each submitted application shall contain only one of the following:

➢ a SINGLE medical device;

➢ one medical device FAMILY;
 ➢ one medical device SYSTEM;
➢ one medical device GROUP;
➢ one dental grouping term (DGT).

The applicant shall undertake the following post-market duties and obligations
for all medical devices and accessories they have registered by the PPB either
individually or as part of grouped registrations:

• comply with the conditions applicable to the registered medical device

and conditions imposed on the Registrant;

• submit applications to the Authority for changes made to the registered

medical device;

• maintain records of supply;

• maintain records of complaints;

• report defects and adverse effects to the Authority; and

• notify the Authority concerning field safety corrective action (FSCA),

including recall.

3.25i Device Specific Grouping of Dental Grouping Terms(DGT)

Dental Grouping Terms (DGT) are collective generic terms used to describe a
group of similar Class A and Class B dental medical devices with a common
intended purpose. DGT is not applicable to Class C and Class D dental medical
devices.

A DGT grouping of dental medical devices is a collection of dental devices and

each individual device:

• is from the same product owner ;

• is of the same risk classification (either Class A only or Class B only); and

• intended purpose falls within the DGT.

3.25iiDEVICE SPECIFIC GROUPING OF HEARING AIDS

This applies only to Class B hearing aids and excludes implantable hearing
devices.
Generally, hearing aids can be categorised based on: • Design (i.e Behind the
ear (BTE) vs In the ear (ITE) (e.g. ITE devices have all components of the
hearing aids are contained in tiny case shell that fits in the ear or canal))

• Technology for sound amplification (i.e. analogue vs digital)

• Communication technology (i.e Wireless vs Non-wireless

communication) A device specific grouping of hearing aids
comprises of a collection of hearing aids that are:

• from the same product owner;

• within risk classification Class B only (hearing aids not including

the implantable hearing devices);

• have the same design type (i.e. behind the ear or in the ear);

• have the same technology for sound amplification (i.e. analogue or

digital); and

• have the same communication technology (i.e. wireless or non-wireless)

3.26 SUBMISSION OF DOCUMENTS TO THE ONLINE PORTAL

Upon submission via the Online Portal of the Pharmacy and Poisons Board, the
product application fee will be charged immediately. Review of the application
by PPB is based on the data set submitted by the applicant. An input request
will be issued to the applicant if clarification or additional information is
required. A regulatory decision is made based on the outcome of PPB’s review
of the submitted application. Only applications which satisfy the registration
requirements will be registered and listed.

The stop-clock starts whenever PPB issues an input request and ends when
PPB receives a complete and satisfactory response from the applicant.

Table 4 Summary Of Application Process To Be Followed For All Medical

Devices

Step 1 Step 2 Step 3 Step 4

Submission Of Verification Of Revieiwng of the Regualtory
Application To Submitted application outcome and or
The Online Portal Application issuance of
registration
certificate

4. MODULE 1 - LISTING OF CLASS A MEDICAL DEVICES

Upon submission via the Online Portal of the Pharmacy and Poisons Board, the
product application fee will be charged immediately. Review of the application
by PPB is based on the data set submitted by the applicant. An input request
will be issued to the applicant if clarification or additional information is
required. A regulatory decision is made based on the outcome of PPB’s review
of the submitted application. Only applications which satisfy the registration
requirements will be registered and listed.

The stop-clock starts whenever PPB issues an input request and ends when
PPB receives a complete and satisfactory response from the applicant.

Table 5 Summary of Submission Requirements for listing of Class A

No. Document Required Class A

Letter of Authorisation
Proposed Device Labelling (Actual
Artworks, Packaging material in contact
with the product and or the Secondary
packaging to be provided)
Pre-Verification certificate for a Notified
Body in liasons with KEBS.

Certificate of Conformity also acceptable in

place of PVOC
IFU, patient information leaflet and
promotional material (including brochures
and catalogues)
Certificate of analysis (COA) for of all
materials of animal, human, microbial
and/or recombinant origin used and
manufacturing process(Where applicable)
Certificate of Analysis of all materials of
animal, human, microbial and/or
recombinant origin used and
manufacturing process (where applicable)
Information on sterilisation method(s) and
validation standard(s) used(where
applicable)
Regulatory approval from the country of
origin of the product.
Proof of Quality Management

1. System (QMS) – E.g. ISO 13485

certificate, conformity to US FDA
Quality System Regulations
(Certificate of free sale), Japan
MHLW Ordinance 169 or attestation
stating adequate QMS, CE
Certificate from the EU/UK
IRELAND
5. MODULE 2 - REGISTRATION OF CLASS B IVD MEDICAL
DEVICES
Through submission of an applicaiton on the online portal:

products.pharmacyboardkenya.org

Applications will be submitted after registration of the applicants details and

receipt of authorisation details including security passpword.

5.1 Evaluation Routes

There are four evaluation routes for Class B medical devices:

1. Full Evaluation Route (FER)

2. Abridged Evaluation Route (AER)
3. Expedited Class B Registration (EBR) Evaluation Route
4. Immediate Class B Registration (IBR) Evaluation Route

The abridged, expedited and immediate evaluation routes are set out according
to a confidence based approach, leveraging on the approvals by listed medical
device reference regulatory agencies (8) and/or prior safe marketing history of
the Class B devices for a period of five (5) years in the County of origin with
accompanying approvals from that jurisdiction. The types of approvals that
qualify for the abridged, expedited and immediate evaluation are as below.

5.1.1 Full Evaluation Route (FER)

5.1.1.1 Eligibility Criteria
A medical device that has not obtained any prior approval from any
Reference Regulatory Agencies at the point of application will be subject to the
full evaluation route.

5.2.2 Submission Requirements

• Letter of Authorisation
• List of configurations of medical devices to be registered
• Common Submission Dossier Template (CSDT)
• Executive Summary
• Essential Principles Checklist and Declaration of Conformity
• Device Description
• Detailed Information of Design Verification and Validation Documents
 • Full reports of Preclinical Studies including the detailed sterilisation
validation, if applicable
• Clinical Evidence, including publications and full reports of the studies
referenced in the clinical evaluation report Proposed Device Labelling
• Risk Analysis
• Manufacturer Information
• Name and address of the manufacturing site(s)
• Proof of Quality Management System – e.g. ISO13485 Certificate,
Conformity to US FDA Quality System Regulations or Japan MHLW
Ordinance 169
• Manufacturing Process – Flow Chart
For medical device with labelled use beyond the inherent performance of the
device, additional clinical data may be requested to substantiate the
proposed label use.

Table 6 Summary of Submission Requirements (Class B)

No. Document Required Class B FER/AER/

EBR/IBR
Letter of Authorisation
List of configurations of medical devices to
be registered packaging to be provided
Executive Summary

Essential Principles Checklist and

Declaration of Conformity

Device Description

Detailed Information of Design Verification

and Validation Documents
 Full r eports of Pr eclinical Studies
including the detailed sterilisation
validation, if applicable

Risk Analysis

Manufacturer Information (Including

details of Manufacturing Site(s))

Manufacturing Flow Process

Clinical Evidence, including publications

and full reports of the studies referenced
in the clinical evaluation report Proposed
Device Labelling

Proof of Quality Management

1. System (QMS) – E.g. ISO 13485

certificate, conformity to US FDA
Quality System Regulations
(Certificate of free sale), Japan
MHLW Ordinance 169 or attestation
stating adequate QMS, CE
Certificate from the EU/UK
IRELAND

5.1.1.2 Abridged Evaluation Route (AER)

Eligibility Criteria
A medical device that has obtained at least two reference regulatory agency
approval for a labelled use identical to that intended for marketing in Kenya at
the time of submission will qualify for the abridged evaluation route.
3. Expedited Class B Registration (EBR) Evaluation Route
5.4.1 Eligibility Criteria
A Class B medical device may qualify for registration via the EBR route if it
complies with the following conditions;

(i) obtained approval from at least Two of PPB’s independent reference

regulatory agencies for a labelled use identical to that intended for
marketing in Kenya;
(ii) marketed for at least three years in the above independent reference
regulatory agency’s jurisdiction;
(iii) no safety issues globally associated with the use of the medical
device(s) when used as intended by the Product Owner, in the last
three years, defined as
a) no reported deaths;
b) no reported serious deterioration in the state of health3 of any
person; and
c) no open field safety corrective actions (including recalls) at the
point of submission.
OR

(B)
(i) obtained approvals from at least Three of PPB’s independent
reference regulatory agencies for a labelled use identical to that
intended for marketing in Kenya.
5.4.2 Submission Requirements
• Letter of Authorisation
• List of configurations of medical devices to be registered
• Proof of approval from independent reference regulatory agencies –
• Proof of marketing history in the same independent reference regulatory
agency’s jurisdictions i.e. Invoice with date, proof of sale or a declaration on
marketing history
• Declaration of no safety issues globally
• Common Submission Dossier Template (CSDT) dossier approvals from the
independent reference regulatory agencies

5.1.1.4 Immediate Class B Registration (IBR) Evaluation Route

1. Eligibility Criteria
A Class B medical device may qualify for registration via the IBR route if it
complies with the following conditions:

(i) approvals by at least three of PPB’s independent reference regulatory

agencies for intended use identical to that submitting for registration
in Kenya;
(ii) marketed for at least four years in two of the independent reference
regulatory agencies’ jurisdictions; no safety issues globally associated
with the use of the medical device(s) when used as intended by the
Product Owner, in the last three years, defined as
a) no reported deaths;
b) no reported serious deterioration in the state of health3 of any
person; and
c) no open field safety corrective actions (including recalls) at the
point of submission; and
(iv) no rejection/withdrawal of the medical device by/from any reference
regulatory agency/that foreign jurisdiction(s) or Kenya due to quality,
performance/efficacy or safety issues.
For medical device with labelled use beyond the inherent performance of the
device, additional clinical data may be requested post-registration to
substantiate the proposed label use.

PPB’s independent reference regulatory agencies are HC, MHLW,

USFDA,TGA,EU-NB,SWISSMEDIC,SAFDA.

Upon submission via PPB online Portal (portal.pharmacyboardkenya.org, the

medical device will be registered immediately and will be listed on the PPB
Online registry within an hour. An email notification regarding the successful
registration of the device will be sent within 48 hours of submission in PPB
online Portal. The total fees will also be charged immediately upon successful
submission for this route. As devices are registered immediately upon
successful submission, applicants are reminded to ensure the application
fulfils ALL the eligibility criteria and that all the required information is
entered correctly and accurately.

PPB will verify the documents submitted in PPB online Portal after successful
submission. Based on the intended use of the device by the Product Owner,
additional registration conditions may be imposed post-registration.
The IBR evaluation route facilitates immediate market access for the medical
devices. Any IBR application which fails to fulfil the ALL the registration
criteria specified under Section 5.1.4.1 for the IBR evaluation route or a non-
Class B medical device submitted via the IBR evaluation route would result in
cancellation of the registration and the registration fee will NOT be refunded.

6. MODULE 3 - REGISTRATION OF CLASS C AND D IVD

MEDICAL DEVICES

Evaluation Routes
There are three evaluation routes for Class C and D IVD medical devices:

(i) Full Evaluation Route

(ii) Abridged Evaluation Route
(iii) Expedited Evaluation Route
a. Expedited Class C Registration (ECR)
b. Expedited Class D Registration (EDR)

Approvals from EU and TGA will qualify as independent reference regulatory

agency’s approval only if the devices have been reviewed and approved by the
respective agencies and the devices are not registered based on the Mutual
Recognition Agreement (MRA).

The abridged and expedited evaluation routes are set out according to a
confidence based approach, leveraging on the approvals by PPB’s medical
device reference regulatory agencies and/or prior safe marketing history. The
types of approvals that qualify for abridged and expedited Class C and D
evaluation routes are as listed below;

Full Evaluation Routes

Eligibility Criteria
A medical device that has not obtained any prior approval from any of PPB’s
reference regulatory agencies at the point of application will be subject to the
full evaluation route.
Abridged Evaluation Route
Eligibility Criteria
A medical device that has obtained at least three reference regulatory agency
approval for a labelled use identical to that intended for marketing in Kenya at
the time of submission will qualify for the abridged evaluation route.

Expedited Class C Registration (ECR) Evaluation Route

Eligibility Criteria
A Class C medical device may qualify for registration via the following routes if
it complies with the following conditions:

(A) ECR:

(i) obtained approval from at least three of PPB’s independent reference

regulatory agencies for a labelled use identical to that intend for
marketing in Kenya; [PPB’s medical device independent reference
regulatory.
(ii) marketed for at least five years in the above independent reference
regulatory agency’s jurisdiction2; and
(iii) no safety issues globally associated with the use of the medical device(s)
when used as intended by the Product Owner, in the last three years,
defined as
a) no reported deaths;
b) no reported serious deterioration in the state of health3 of any
person; and
c) no open field safety corrective actions (including recalls) at the point
of submission
OR

(B) ECR:

(i) obtained approvals from at least five of PPB’s independent reference

regulatory agencies for a labelled use identical to that intended for
marketing in Kenya.
Approvals from EU and TGA will qualify as independent reference regulatory
agency approvals only if the devices have been reviewed and approved by the
respective agencies and not registered based on the Mutual Recognition
Agreement (MRA).
Or the medical device has been marketed in the jurisdiction of the reference
regulatory agency for at least 5 years as stated in the proof of marketing

history. For devices that are part of a test kit or a system, an invoice or
declaration containing the kit name or system will be sufficient.

The following Class C devices are excluded from submission via the ECR
evaluation route:

(i) Hip, knee and shoulder joint replacement non bio-active implants (e.g.
non-bioactive metal/polymer implants).
These devices will have to be registered via Full or Abridged routes only.

Processing times

Upon submission via ppb Online Portal , an application fee will be charged
immediately. The application will be verified for eligibility for ECR and the
dossier will be verified for completeness. Once confirmed, the application will
be accepted for evaluation. The evaluation fees will be charged at this point. In
the event that the application does not qualify for ECR, the application will be
required to be re-routed to the abridged or full evaluation route and the
respective evaluation fees shall apply.

Evaluation of the dossier by PPBis based on the data set submitted by the
applicant. An input request will be issued to the applicant if clarification or
additional information is required. A regulatory decision is made based on the
outcome of PPB’s evaluation of the submitted dossier. Only applications which
satisfy the registration requirements will be registered and listed on the PPB
Online Registry.

The stop-clock starts whenever PPBissues an input request and ends when
PPBreceives a complete and satisfactory response from the applicant.

Expedited Class D Registration (EDR) Evaluation Route

Eligibility Criteria
A Class D medical device may qualify for registration via the EDR route if it
complies with the following condition:

(i) obtained approvals from at least five of PPB’s independent reference

regulatory agencies for a labelled use identical to that intended for
marketing in Kenya.
The following Class D devices are excluded from being registered via EDR
route:

(i) Active implantable devices (e.g. pacemakers, neurostimulators)

(ii) Implantable devices in direct contact with the central circulatory system
or central nervous system
(iii) Hip, knee and shoulder joint replacement (e.g. bioactive implants)
(iv) Devices incorporating a registrable drug in an ancillary role
(v) IVD devices intended for:
• HIV testing (screening and diagnosis)
• Blood/ tissue donor compatibility testing
These devices will have to be registered via Full or Abridged evaluation routes
only.

Table 7 Summary of Submission Requirements (Class C/D)

No. Document Required Class C/D FER/

AER/EBR/
Letter of Authorisation
List of configurations of medical devices to
be registered packaging to be provided
Executive Summary

Essential Principles Checklist and

Declaration of Conformity

Device Description

Detailed Information of Design Verification

and Validation Documents
 Full r eports of Pr eclinical Studies
including the detailed sterilisation
validation, if applicable

Risk Analysis

Manufacturer Information (Including

details of Manufacturing Site(s))

Manufacturing Flow Process

Clinical Evidence, including publications

and full reports of the studies referenced
in the clinical evaluation report Proposed
Device Labelling

Proof of Quality Management

1. System (QMS) – E.g. ISO 13485

certificate, conformity to US FDA
Quality System Regulations
(Certificate of free sale), Japan
MHLW Ordinance 169 or attestation
stating adequate QMS, CE
Certificate from the EU/UK
IRELAND

TURN-AROUND-TIME (TAT) FOR PRODUCT REGISTRATION

PPB shall endeavor to meet the target processing timelines for all submitted
applications. Applicants should ensure that the dossiers are complete before
submission. Incomplete submissions and untimely responses to queries will
result in unnecessary delays to the registration process and thus, will have a
negative impact on the target processing timelines.
The target turn-around-time (TAT) for product registration applications
commences from the date of receipt of the application and does not include
‘stop-clock time’ due to input requests for clarifications and additional
information.

In the event that the medical device is a subject of a Field Safety Corrective
Action (FSCA), the application will be placed on stop-clock until resolution of
the FSCA.

Table 8: Turn-around-time (TAT) for medical devices registration

R i s k TAT for Registration (in working days)

classification
Class A 30
R i s k TAT for Registration (in working days)
Classification
Immediate Expedited Abridged Full
Class B I m m e d i a t e 60 100 160
registration
u p o n
submission
(Registration
within 48
hours upon
submission)
Class C 120 160 220
Class D 180 220 310

7. PRODUCT REGISTRATION FEES

The application fee is payable at the time of submission in PPB Online Portal.
Evaluation fees are payable upon acceptance of the application for evaluation.
The application fees are non-refundable once the application has been
successfully submitted via PPB Online Portal. The applicant should ensure
that the product registration application is compiled according to the
prevailing required format.

The evaluation fees are non-refundable once the application is accepted for
evaluation, regardless of the final decision by PPB. Withdrawal of the
application after the application is accepted will result in forfeiture of the
evaluation fees. Rejection of the application by PPB will also result in the
forfeiture of the evaluation fees.

Table 9 Fees for registration of Medical Devices

Risk Class Application Evaluation fees

Fees
IBR Expedited Abridged Full
Class A $100
Class B $500 $900 $900 $1,800 $3,500
Class C $500 $5,000 $7,500 $8,700
Class D $500 $8000 $25,000 $35,000
Class D $500 $15,000 $35,000

Devices
incorporating
registrable
medicinal
products

1. CHANGES TO A REGISTERED MEDICAL DEVICE

Registrants are required to submit a “Change Notification” application, if there
are any changes or proposed changes to particulars provided in relation to the
registration of the medical device, and/or if there are any changes or proposed
changes that may affect the safety, quality or efficacy of a registered medical
device.

Please refer to Guidance on Change Notification for Class A and B, and

Guidance on Change Notification for Registered Medical Devices, for the types
of changes and required documents to be provided for a Change Notification
submission.

2. AMENDMENT OF DEVICE LISTING

In cases of any typographical errors incurred in the device listing information
on the PPB Online Portal, the Registrant may submit a written request to PPB
for the necessary amendments

ANNUAL RETENTION FEE

An annual retention fee is payable in order to retain the registration of the

medical device on the PPB Online Registry.

The payment of the retention fee should be submitted via PPB Online Portal.
Submission via the system will be available 60 days before the due date of the
annual retention fee. A payment reminder will be sent to the email address
provided by the Registrant. However, it is the responsibility of the registrant to
keep track of the annual retention due date. Failure to make the necessary
payment may lead to suspension and cancellation of the registration of the
medical device.

The annual registration retention fees are non-refundable.

Table 10 of Retention Fee’s for Medical Devices

Annual Retention Feel Amount in USD per Product

A 25
B 100
C 500
D 750
3. SUSPENSION AND CANCELLATION OF REGISTRATION
Pursuant to section the Cap 244 Laws of Kenya, when a regulatory decision
has been made on reasonable grounds to suspend or cancel a registered
product, the Registrant will be given written notice. The Registrant will also be
given an opportunity to be heard prior to the suspension or cancellation.

Once the registration is suspended or cancelled, the applicant and all dealers
are required to immediately cease all activities related to the importation and
supply of the affected medical devices including IVD Medical Devices.

ANNEX 1

Letter of Authorisation Template

[To be printed on Company Letterhead of Product Owner]

Medical Device Department

Pharmacy and Poisons Board

Lenana Road Offices

P.o Box 27663-00508

Nairobi,Kenya.

[Date]

Dear Sir/Madam,

Subject: Letter of Authorisation for [name of Registrant (Company Name)]

We, [name of Product Owner], as the Product Owner, hereby authorise [name of
Registrant (Company Name)], as the Registrant to prepare and submit
applications for the evaluation and registration of medical devices to the Health
Sciences Authority on our behalf.

This authorisation shall apply to the following medical devices:

[List containing product names of medical devices]

We also authorise [name of Registrant (Company Name)] to make declarations

and to submit documents on our behalf, regarding the above medical devices,
in support of this application. These declarations and submissions are made
pursuant to the requirements of the Health Act 2017, which includes the
Health Products and Technologies and any other applicable laws that may also
be in force.

This authorisation shall remain in effect until our notification to the Pharmacy
and Poisons Board in writing (either by postal mail or facsimile transmission)
that the authorisation is revoked.

We undertake to provide post-market support and assistance to the Registrant

as may be required in relation to any matter involving the above medical
devices.

We acknowledge that any non-compliance with any registration condition

issued by the Pharmacy and Poisons Board in relation to medical devices
registered in Kenya may result in the suspension or cancellation of the medical
device registration.

We agree to assist the Pharmacy and Poisons Board with any request for
information on the above medical devices.
Yours Sincerely,

[Signature]

[Full Name and Title of Senior Company Official]

[Company stamp]

ANNEX 2
Marketing History Declaration Template
[To be printed on Company Letterhead of Applicant]
Medical Device Department

Pharmacy and Poisons Board

Lenana Road Offices

P.o Box 27663-00508

Nairobi,Kenya.

[Date]

Dear Sir/Madam,

I, [name of Company], the Applicant for registration of the medical device(s)

stated below, hereby declare that the medical devices have been marketed in

the reference regulatory agency’s jurisdiction for at least three years. The
first date of market introduction in [jurisdiction/country] was [mm/yyyy] (for
ECR 1).

OR
 reference stringent authority for at least three years. [mm/yyyy] (for ECR 1.)

This declaration is made with respect to the following medical device(s):

[List containing product names of medical devices]

I, the Applicant, am aware that making a declaration which I know to be

false is an offence under the Health Act 2017 (Cap. 244 Laws of Kenya) and
may result in the cancellation of registration of the above medical devices.

Yours Sincerely,

[Signature]

[Full Name and Title of Senior Company Official]

[Company stamp]

Annex 3

Safety Declaration Template

[To be printed on Company Letterhead of Applicant]

Medical Device Department

Pharmacy and Poisons Board

Lenana Road Offices

P.o Box 27663-00508

Nairobi,Kenya.

[Date]

Dear Sir/Madam,

I, [name of Company], the Applicant for registration of the medical device(s) stated
below, hereby declare that there are no safety issues globally associated with the use
of the medical device(s) when used as intended by the Product Owner, in the last three
years from [dd/mm/yyyy] to [dd/mm/yyyy]:

No reported deaths;

No reported serious deterioration in the state of health1 of any person; and

No open field safety corrective actions (including recalls) at the point of submission of
this application.

This declaration is made with respect to the following medical device(s):

[List containing product names of medical devices]

I, the Applicant, am aware that making a declaration which I know to be false

is an offence under the Health Act 2017 (Cap. 244 Laws of Kenya) and may
result in the cancellation of registration of the above medical devices.

Yours Sincerely,

[Signature]

[Full Name and Title of Senior Company Official]

[Company stamp]

Annex 4 Risk Based Classification of Medical Devices with Examples

Category Classification Examples

 1. Non-Invasive Class A- if they are • Cotton wool, bandages
Medical Devices intended to be used • administration sets for
-All Non-Invasive as a mechanical gravity infusion;
devices which come barrier, for syringes without
into contact with Compression or for needles.
injured skin absorption of • urine collection bottles;
-if they are intended exudates only (they compression hosiery;
for channelling or heal by primary non-invasive electrodes,
storing intent) hospital beds.
liquids, or gases • where the •
for the purpose of devices either
eventual infusion, do not touch
administration or the patient or
introduction into the contact intact
body (Such devices are skin only.
‘indirectly invasive’ in •
that they channel or
that they channel or
store liquids that will Class B- if they are • Non-medicated
eventually be delivered intended to be used impregnated gauze
into the body) principally with dressing
wounds which have
breached the dermis
• Including
devices
principally
intended to • syringes and
manage the administration sets for
micro- infusion pumps;
environment of anaesthesia breathing
a wound. circuits
• If they may be
connected to an
active medical
device in Class
B or a higher
class .N.B
“Connection” to
an active device
covers those
circumstances • Tubes used for blood
where the transfusion, organ
safety and storage containers
performance of
the active
device is
influenced by
the non-active
device and vice
versa.
• if they are
intended to be • devices to remove
used for - carbon dioxide;
channeling particulate filters in an
blood, or extracorporial
storing or circulation system
channeling
other body
liquids, or
storing organs,
parts of organs
or body tissues,
for the purpose
of eventual
infusion,
Class C- if they are • Dressings for chronic
intended to be used ulcerated wounds;
principally with dressings for severe
wounds which have burns
breached the dermis
and can only heal by
secondary intent • Blood Bags that do not
• If they are incorporate an anti-
Blood Bags that coagulant
do not
incorporate an
anti-coagulant
• All non-invasive
devices • haemodializers; devices
intended for to remove white blood
modifying the cells from whole blood.
biological or
chemical
composition of
blood, other
body liquids, or
other liquids,
intended for
infusion into
the body(N.B
Such devices
are ‘indirectly
invasive’ in that
they treat or
modify
substances
that will
eventually be
delivered into
the body. They
are normally
used in
conjunction
with an active
device within
the scope of
either Rule 9 or
11)
Invasive Medical 1. Class A- All • Examination
Devices invasive devices gloves; enema
with respect to devices
body orifices
(other than
those which are
surgically
invasive) and
which:
➢ -Are not
intended for
connection to
an active
medical device,
or
➢ Are intended for
connection to a
Class A medical
device only.
➢ If they are
intended for
transient use
N.B Such devices are
invasive in body
orifices and are not
surgically
invasive .Devices tend
to be diagnostic and
therapeutic
instruments used in
ENT, ophthalmology,
dentistry, proctology,
urology and
gynaecology. • dressings for
Classification nose bleeds
depends on the
duration of use and
the sensitivity (or
vulnerability) of the
orifice to such
invasion. • Manually
2. if they are intended operated surgical
for short-term use in drill bits and
the oral cavity as far saws.
as the pharynx, in an •
ear canal up to the
ear drum or in a
Class B- if they are ➢ urinary catheters,
intended for short- tracheal tubes.
term use. ➢ Orthodontic materials,
they are intended for removable dental
long-term use in the prosthesis
oral cavity as far as
the pharynx, in an
ear canal up to the
ear-drum or in a
nasal cavity and are
not liable to be
absorbed by the
mucous membrane
All invasive devices
with respect to body
orifices (other than
those which are
surgically invasive) ➢ Example-tracheal tubes
that are intended to connected to a
be connected to an ventilator; suction
active medical device catheters for stomach
in Class B or a higher drainage; dental
class. aspirator tips.
2. All surgically
invasive devices
intended for
transient use
1. All implantable
devices, and ➢ A majority of such
long-term devices fall into several
surgically major groups: those
invasive that create a conduit
devices that are through the skin (e.g.
intended to be syringe needles;
placed into the lancets), surgical
teeth or on instruments (e.g. single-
prepared tooth use scalpels; surgical
structure. staplers; single-use
2. aortic punch); surgical
gloves; and various
types of catheter/
sucker
➢ materials for inlays,
crowns, and bridges;
dental filling materials.
• Class C- if they ➢ urethral stent; contact
are intended lenses for long-term
for long-term continuous use
use; ➢ catheter containing
• if they are sealed radioisotopes
reusable
surgical
instruments
intended to
supply energy
in the form of ➢ Example-Insufflation
ionizing gases for the abdominal
radiation cavity.
• intended to
have a
biological effect
or be wholly or
mainly
absorbed(NOTE
S: (a) The
‘biological
effect’ referred
to is an
intended one
rather than
unintentional.
The term
‘absorption’
refers to the
degradation of
a material
within the body
and the
metabolic
elimination of
the resulting
degradation
products from
the body.
(b) This part of ➢ insulin pen for self-
the rule does administration
not apply to
those
substances
that are
excreted
without
• Class D- they • spinal needle
are intended
specifically for
use in direct
contact with
the central
nervous system • angioplasty balloon
• If they are - catheters and related
intended guide wires; dedicated
specifically to disposable
diagnose, cardiovascular surgical
monitor or instruments
correct a defect
of the heart or
of the central
circulatory
system through
direct contact
with these
parts of the • absorbable suture;
body biological adhesive
• they are
intended to • Neurological catheter.
have a
biological effect
or to be wholly
or mainly
absorbed.
• they are
intended • cardiovascular
specifically for catheters; temporary
use in direct pacemaker leads;
contact with carotid artery shunts
the central
nervous system
• they are
intended
specifically to
diagnose,
monitor or • prosthetic heart valves;
correct a defect cardiovascular stents;
of the heart or pacemaker leads and
of the central electrodes; deep brain
circulatory stimulation electrodes;
system through cerebrospinal catheter.
direct contact
with these • -pacemakers;
Active Medical Devices • Class A- If they • examination lamps;
are devices surgical microscopes;
used solely to powered hospital beds
illuminate the & wheelchairs; powered
patient's body, equipment for the
with light in the recording, processing,
visible or near viewing of diagnostic
infra-red images; dental curing
spectrum. lights.
•
Class B- All active • muscle stimulators;
therapeutic devices powered dental hand
intended to pieces; hearing aids;
administer or neonatal phototherapy
exchange energy equipment; ultrasound
(Such devices are equipment for
mostly electrically physiotherapy.
powered equipment
used in surgery;
devices for
specialised treatment
and some • Equipment for
stimulators.) ultrasonic diagnosis/
➢ If they are imaging, capture of
active devices physiological signals.
intended for • magnetic resonance
diagnosis equipment; diagnostic
➢ If they are ultrasound in non-
active devices critical applications;
intended to evoked response
supply energy stimulators
which will be
absorbed by the
human body
➢ if they are
intended to • gamma/nuclear
image in vivo cameras.
distribution of
radiopharmace
uticals ➢ Examples-electronic
➢ If they are thermometers,
active devices stethoscopes and blood
that are pressure monitors;
intended to electrocardiographs
allow direct
diagnosis or
monitoring of
vital
physiological
processes • Examples-suction
➢ All active equipment; feeding
devices pumps; jet injectors for
intended to vaccination; nebuliser
administer to be used on conscious
and/or remove and spontaneously
medicinal breathing patients
products, body where failure to deliver
Class C- their ➢ lung ventilators; baby
characteristics are incubators;
such that they may electrosurgical
administer or generators; external
exchange energy to or pacemakers and
from the human body defibrillators; surgical
in a potentially lasers; lithotriptors;
hazardous way, therapeutic X-ray and
including ionizing other sources of
radiation, taking ionizing radiation
account of the
nature, the density
and site of
application of the
energy • external feedback
-All active devices systems for active
intended to control or therapeutic devices.
monitor the
performance of active
therapeutic devices in
Class C, or intended
directly to influence
the performance of
such devices • monitors/alarms for
-if they are intended intensive care;
they are specifically biological sensors;
intended for: oxygen saturation
a) monitoring of monitors; apnoea
vital monitors.
physiological
parameters,
where the
nature of
variations is
such that it
could result in
immediate
danger to the
patient, for
instance
variations in
cardiac
performance,
respiration,
activity of
central nervous • ultrasound equipment
system. for use in interventional
Exeptional Classes • Class D- All • Examples antibiotic
1. Medical Devices devices bone cements; heparin-
which incorporating, coated catheters;
Incorporate as an integral wound dressings
Medicinal part, a incorporating
Substances substance antimicrobial agents to
which, if used provide ancillary action
separately, can on the wound; blood
be considered bags incorporating an
to be a anti-coagulant
medicinal
product, and
which is liable
to act on the
human body
with action
ancillary to
that of the
devices
• This medical
devices
incorporate
Medicinal
substances in
an ancillary
role

• Devices • Class A- A- • leather components of

manufactured such devices orthopaedic appliances
from or are
incorporate non- manufactured
viable animal from or
tissues or their incorporate
derivatives non-viable
animal tissues
or their
derivatives that
come in contact
with intact skin
only
 • Medical Devices- Class A- they are
used for intended to clean
sterilizing or medical devices by
Disinfecting means of physical
Medical Devices action only

Class B: All • desk-top sterilisers for

devices intended use with dental
specifically to be instruments.
used for sterilising •
or disinfecting
medical devices

• Class C- they • solutions intended to be

are disinfectant used for the
solutions or disinfection of medical
washer- devices without further
disinfectors processing (for example
intended in a steriliser) including
specifically for those where the
invasive infective agent is a
medical prion;
devices, as the •
end point of
processing,
• washer-
disinfector
equipment
specifically for
disinfecting an
endoscope or
another
invasive device

Medical Devices Class D: All devices • porcine heart valves

Incorporating Animal manufactured from
or Human Cells/ or incorporating
Tissues/Derivatives animal or human
cells/tissues/
derivatives thereof,
whether viable or
non-viable
Medical Devices for Are in Class C-All • Contact cleaning
Ophthalmic Solutions devices that are solutions
Use intended specifically
to be used for
disinfecting, cleaning,
rinsing or, when
appropriate,
hydrating contact
lenses

Medical Devices for Class C- All devices • Condoms;

Contraception or the used for Contraceptive
prevention of STD’s contraception or the diaphragms
prevention of the
transmission of
sexually transmitted
diseases

Implantable Medical Class D- they are • intrauterine

Devices for Long-term implantable or long- contraceptive
Use term invasive devices device

Annex 5 Example of an Essential Principles Conformity Checklist

Essential Principle Applicable to Method of Identity of

the device? Conformity Specific
Documents
Medical devices should be
designed and
manufactured in such a
way that, when used
under the conditions and
for the purposes intended
and, where applicable, by
virtue of the technical
knowledge, experience,
education or training of
intended users, they will
not compromise the
clinical condition or the
safety of patients, or the
safety and health of users
or, where applicable,
other persons, provided
that any risks which may
be associated with their
use constitute acceptable
risks when weighed
against the benefits to the
patient and are
compatible with a high
level of protection of
health and safety
The solutions adopted by
the product owner for the
design and manufacture
of the devices should
conform to safety
principles, taking account
of the generally
acknowledged state of the
art. When risk reduction
is required, the product
owner should control the
risk(s) so that the residual
risk(s) associated with
each hazard is judged
acceptable. The product
owner should apply the
following principles in the
priority order listed: •
identify known or
foreseeable hazards and
estimate the associated
risks arising from the
intended use and
foreseeable misuse,
• eliminate risks as far as
reasonably practicable
through inherently safe
design and manufacture,
• reduce as far as is
reasonably practicable the
remaining risks by taking
adequate protection
measures, including
alarms, • inform users of
any residual risks.

References

1. Global Harmonization Task Force (GHTF)-/SG1/N12:2000 Role of

Standards in the Assessment of Medical Devices.
2. 2.GHTF/SG1/N29:2005 Information Document Concerning the
Definition of the Term ‘Medical
3. Device’.
4. 3.GHTF/SG1/N40:2006 Principles of Conformity Assessment for Medical
Devices.
5. GHTF/SG1/N41:2005 Essential Principles of Safety and Performance of
Medical Device.

6. The Global Harmonization Task Force (GHTF)which is now The

International Medical Devices Regulatory Forum (IMDRF)

7. 6..The Asian Harmonization Working Party (AHWP)

8. British Standard Institute

9. Health Safety Authority

10.Global Medical Devices Agency

11.ISO Standards