The document discusses risk-based classification and grouping of medical devices in Kenya. It describes how medical devices will be classified into categories A, B, C, and D based on factors like invasiveness and risk level. It also discusses how devices can be grouped into single devices, device families that include variations of a device, and device systems which are groups of compatible devices that serve a common purpose. Proper classification and grouping is important for the registration of medical devices in Kenya.

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REPUBLIC OF KENYA
MINISTRY OF HEALTH
PHARMACY AND POISONS BOARD
RISK BASED CLASSIFICATION AND GROUPING OF
MEDICAL DEVICES
DR PAULYNE WAIRIMU
25th October 2018
Stakeholders sensitization
PPB Boardroom, Lenana Road.
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Introduction
-Risk Based Classification of MD’s
-STED
-Grouping of MD’s
-Overviews & Summary
Medical Devices Roadmap

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Medical Devices Roadmap
§2015-Setting up of the
department under DPER
§2016 Listing of Medical Devices
with a view of knowing products
in the market
§2016-Import/Export control
with requirements for permit for
importation
§2017-Establishment of Online
Platform, creating a national
Database of all Products coming
into the country
§2017-Enactment of the Health
Act
• Reference: AHWP-PLAY BOOK
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RBC AND GROUPING
• Risk based classification of MD’s
• For MD’s risk based on invasiveness to the
body
• For IVD’s, risk is based on degree of public
health
• Grouping is a system to help in the
registration of similar product categories
• Grouping of products in the same class.
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Risk Based Classification
• Classification of Medical
Devices to follow the A,B,C,D
model.
• Classification is based on the
following factors
ü Duration of contact with the body
with the Medical Device
ü The degree of Invasiveness
ü medical device delivers
medicinal products or energy to
the patient
ü intended to have a biological
effect on the patient
ü Local Versus Systemic Effect
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RISK BASED CLASSIFICATION OF IVD
MEDICAL DEVICES
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CLASS RISK LEVEL DEVICE EXAMPLES
A Low Individual Risk
and Low Public
Health Risk
Clinical Chemistry Analyser, prepared selective culture media
B Moderate Individual
Risk and/or Low
Public Health Risk
Vitamin B12, Pregnancy self-testing, Anti-Nuclear Antibody, Urine test
strips
C
High Individual Risk
and/or Moderate
Public Health Risk
Blood glucose self-testing, HLA typing, PSA screening, Rubella
D High Individual Risk
and High Public
Health Risk
HIV Blood donor screening, HIV Blood diagnostic

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STED
• “Summary Technical Documentation for
Demonstrating Conformity to the Essential
Principles of Safety and Performance of
Medical Devices (STED)”.
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STED
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GROUPING OF MD’s
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Grouping Defined
• For example, TRS MDB ORTHOPAEDIC SYSTEM consists of
the following constituent- components (refer to Figure 1):
• Instruments from ABC Bhd (a subsidiary of TRS MDB Kenya),
• Instruments from XYZ Bhd (a subsidiary of TRS MDB Mexico),
• Plates from TRS MDB Uganda; and
• Screws from TRS MDB Zimbambwe
• For the purpose of grouping, the manufacturer of TRS
ORTHOPAEDIC SYSTEM will be TRS MDB KENYA (The
Headquarters representing)
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Single Medical Device
• A SINGLE medical device is a medical device
from a manufacturer identified by a medical
device proprietary name with a specific intended
purpose. It is sold as a distinct packaged entity
and it may be offered in a range of package
sizes.
• Examples
• Condoms that are sold in packages of 3, 12 and 144 can be registered as a SINGLE medical device.
• A company manufactures a software program that can be used with a number of
CT scanners produced by other manufacturers. Although the software cannot function on its own, it can be used
on different scanners. The software can be registered as a SINGLE medical device.
• A company that assembles and registers a first aid kit has now decided to also
supply each of the medical devices in the first aid kit individually. Each medical device supplied individually must
be registered separately as a SINGLE medical device.
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Device family
• A medical device FAMILY is a collection of
medical devices and each medical device
FAMILY member:
• is from the same manufacturer;
• is of the same risk classification;
• has the same generic proprietary name;
• has a common intended purpose;
• has the same design and manufacturing process; and
• has variations that are within the scope of the permissible variants.
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Device system
• A medical device SYSTEM comprises of a
number of constituent-components that are:
– from the same manufacturer;
– intended to be used in combination to complete
a common intended purpose;
– compatible when used as a SYSTEM; and
– sold under a SYSTEM name or the labeling,
instruction for use (IFU), brochures or catalogues
for each constituent component states that the
constituent component is intended for use with the
SYSTEM
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Device System as a Family
• In addition, if several SYSTEMs ful-fill the following conditions to be
grouped as a FAMILY, they may be registered as a FAMILY:
• the SYSTEMs are from the same manufacturer;
• the SYSTEMs are of the same risk classification class;
• the SYSTEMs have a common intended purpose;
• the SYSTEMs have the same design and manufacturing process;
and
• key constituent-components of the SYSTEMs have variations
that are within the scope of
• the permissible variants.
• has the same generic proprietary name
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Device System Example
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Dental Grouping Term
• Similar to the system
grouping
• Dental material falling
in the same
categories
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Thank You!
• Email: pwairimu@pharmacyboardkenya.org
• Medicaldevices@pharmacyboardkenya.org
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