The document discusses Kenya's efforts to strengthen regulation of medical devices and in vitro diagnostics (IVDs) to support universal health coverage. It outlines Kenya's regulatory system, including new guidelines for medical device registration and an online portal for submissions. A phased implementation approach is proposed, beginning with higher risk devices. International harmonization is emphasized to facilitate access while ensuring safety. The timeline targets public use of the online system and initial registrations in early 2019.

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REPUBLIC OF KENYA
ACCESS TO MEDICAL PRODUCTS IN ATTAINMENT OF
UNIVERSAL HEALTH COVERAGE
DR PAULYNE WAIRIMU
3rd
-5th
OCTOBER 2018
Horn of Africa Conference & Expo
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REGULATION OF MEDICAL DEVICES
INCLUDING IVD’s in KENYA

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Outline of Presentation
• Introduction
• Regulatory System strengthening
• Overview of the medical device guideline for registration, life
cycle and associated regulatory activities
• Overview of the Guideline on submission of Medical Devices
&IVDs
• Medical Devices roadmap and Phased implementation
• Online Portal Timeline
• Overviews & Summary
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Introduction
• Universal Health Coverage (UHC), one of the Big 4
agendas’ of the Government - prioritizes the provision
of affordable, quality healthcare Service to the Kenyan
Citizen.
• Central to the achievement of the UHC is the
strengthening of regulatory systems
• Regulatory systems for Medical Devices including
IVD’s are relatively new across the regulatory
authorities in comparison to more defined
Pharmaceutical practices.

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Regulation of Medical Devices
• ‘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;
• Member states……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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Towards Regulatory Convergence
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Regulatory convergence of regulatory procedures
and harmonization efforts will results
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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Overview of the Guideline
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• The guideline for submission of Medical Devices
including IVD’s is aligned to the International
Medical Devices Regulators Forum (Formerly
GHTF) recommended Common Submission Dossier
Template (CSDT)
• The CSDT contains elements of the GHTF
Guidance document ‘“Summary Technical
Documentation for Demonstrating Conformity to
the Essential Principles of Safety and Performance
of Medical Devices (STED)”.

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Evaluation routes in accordance to
regulatory approval by RRA
• Reference regulatory authorities(RRA)
• Identified in accordance to GHTF membership
and affiliation
• Leveraging on Expertise, Skills, Experiences
and Best Practices, transparency and trust
between authorities
• Aimed at facilitating access of the medical
product to the market.
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Evaluation routes based on Class
of Product
• Full Evaluation Route (FER)—Where a medical device has not
obtained any prior approval
• -Comprehensive clinical/Quality Management Data required
• -Will have the longest approval period.
• Abridged Evaluation Route(AER)
• -approval by at-least two RRA
• Expedited Class B Registration (EBR) Evaluation Route
• -Approval from at-least two RRA, Marketed for atleast 3 years in the
jurisdiction of approval, no safety issue globally, no reported Deaths
associated with product, and no reported serious deterioration in the
state of health, no field safety corrective action.
• Immediate Class B Registration (IBR) Evaluation Route – fulfils
all the above requirements in addition to no withdrawals,rejections,
or field safety corrective action.
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2014/5
2018/9
2012/3
-Establishment of the online portal for electronic submission/reviews (2017/8)
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

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Medical Devices Roadmap
2012/3-Control of IMPORTS
2014/5-Setting up of the
department under DPER,
manual process
2016 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
2017-Enactment of the Health
Act
2018/9-Registration of MDs and
IVDs 10

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Overview of the medical device life cycle and
associated regulatory activities
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Ref: AHWP PLAYBOOK

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Categories of medical Devices standards
Ref: AHWP PLAYBOOK

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Registration requirements
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• Online portal of the PPB.
• STED- “Summary Technical
Documentation for Demonstrating
Conformity to the Essential Principles
of Safety and Performance of Medical
Devices (STED)”.
• CSDT Format- Common Submission
Dossier Template (CSDT)

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Timelines for the implementation of
ONLINE PORTAL
• 8th
October 2018- 2ND
System testing by Internal
programmer/DPER
• 15th
October 2018 3rd
-System testing with Cohort
• 22ND
October 2018- extended system testing
through stakeholder invitations to test the system
• 15th
November 2018-Public interaction with the
interface; pave way for system input
• January 2019- Registration of MD’s
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Way forward
• Operationization of the Guideline for registration of
Medical Devices including IVD’s.
• Registration phased in accordance to risk of
Product.
• Volume of applications an indicator of the growing
market needs and regulatory framework that is
comprehensive
• Compliance with the online listing procedure an
indicator of the system preference.
• Challenges still being addressed with the system
upgrading to cater for the registration needs.
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References
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• WHO Model regulatory framework for medical
devices
• AHWP-Playbook
• IMDRF-guidance documents
• WTO-promoting Access to Medical Technologies
and innovation

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Contacts
Contacts
Pharmacy and Poisons Board
Lenana Road
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Email: pwairimu@pharmacyboardkenya.org

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Asante Sana
• Thank you • Merci Beaucoup
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