The regulatory landscape for medical devices has in recent years witnessed changes. This presentation gives an overview of the changes and the anticipated phased registration process of Medical Devices in kenya as regulatory system strengthening is developed.

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REPUBLIC OF KENYA
MINISTRY OF HEALTH
PHARMACY AND POISONS BOARD
OVERVIEW OF REGULATORY SYSTEM FOR MEDICAL
DEVICES & MILESTONES
DR PAULYNE WAIRIMU
13TH March 2018
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Introduction
• Health is a right to every human being and Every
Kenyan Citizen as stipulated in the Constitution of
Kenya 2010.
• Universal Health Coverage (UHC), which is a priority
in the current Government action plan seeks to have
every Kenyan receiving affordable, quality healthcare
Service.
• Kenya’s Vision 2030, the National Health Policy 2012-
2030 focuses on health as a contributor to economic
development.
• Central to the achievement of the UHC is the
strengthening of regulatory systems

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Regulation of Medical Devices
• World Health Assembly resolution67.20 ‘Regulatory system
strengthening for Medical Products’
• …..WHO’s mandate pertaining to regulatory system strengthening
as an integrated part of health system development, recognizing
that WHO’s support in this critical area, particularly for developing
countries, may be required, as appropriate, well into the future;
• ……to prioritize support for establishing and strengthening
regional and sub-regional networks of regulatory authorities, as
appropriate, including strengthening areas of regulation of health
products that are the least developed, such as regulation of
medical devices, including diagnostics
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Medical Devices Roadmap from
Inception-Now
§ 2012/13 Import Control through
requirement for import permit
§ 2014/15-Setting up of the department
under Directorate of Product Evaluation
&Registration(DPER)
§ 2015/16 Manual Voluntary Listing of
Medical Devices with a view of knowing
products in the market
§ 2017-Establishment of Online Platform,
creating a national Database of all
Products coming into the country &
players in Manufacturing, Imports,
Distributors.
§ 2017-Enactment of the Health Act in
September- Legislative Framework for
Health Technologies, Medical Products
under Single Regulatory Authority
4Reference: AHWP-PLAY BOOK

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2014/5
2018
2012/3
-Recommended regulatory phased implementation by the AHWP
-Membership to the AHWP looking towards Harmonization
-Mandatory Registration of Medical Devices,Establishment license and
QMS requirements,Pre-Market Evaluation,Clinical
Investigations=Registration requirements
Phased implementation
Reference: AHWP-PLAY BOOK

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Towards Regulatory Convergence
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Regulatory convergence of regulatory procedures
and harmonization efforts will result in :
(i)more efficient resource use (e.g. international
and regional sharing of scientific resources and
“best practices”);
(ii) better quality applications to register Medical
Devices from manufacturers;
(iii) cost savings both at the company and
government level; and, as a consequence,
(iv) quicker access to quality essential medical
products that are safe and efficacious.

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International Medical Device
Regulators Forum-IMDRF
• Kenya attended
September 2017 IMDRF
meeting.
• International Medical
Devices Regulators Forum
annual meeting in Ottawa,
Hosted by Health Canada.
• Kenya invited as an
Observer Nation to the
IMDRF
• The International Medical
Devices regulators Forum
(IMDRF)
• Formerly Global
Harmonization Task Force
(GHTF)
• Founding member economies,
US, Canada, Japan, China,
Australia, EU
• Affiliate bodies WHO,AHWP
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Asian Harmonization Working Party
(AHWP)
• Kenya has actively participated in AHWP
meeting, WG2-IVDD
• July 2017- Successful application made to
join membership, as a Member Economy
• December 2017-Annual General Meeting in
New Delhi- Kenya was endorsed as a
Member economy of the AHWP member
economies
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WHO-Geneva
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• May 2017- Kenya reported on her current
position at the 3rd Regulators Forum for
Medical Devices meeting
• -Road Map for medical devices including
IVD’s regulation
• -Legislative Law (Health Act 2017)
• May 2017-World Health Assembly
• -Implementation of the regulatory framework
• -WHO’s mandate to support developing
countries

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Conclusion
• The regulation of Medical Devices has seen
development since its inception in 2012.
• Milestones so far are promising to deliver the
final steps of the bigger regulatory framework
• -Reviewing of all applications coming into the
country
• -Control of Imports/Exports
• -Pre-Verification of pre-shipments
• -Online submission of applications
• -Field safety Updates 10

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Thank You!
• Email: pwairimu@pharmacyboardkenya.org
• Medicaldevices@pharmacyboardkenya.org
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