This document summarizes guidelines for registering medical devices in Kenya. It defines medical devices and in vitro diagnostic devices. It outlines the medical device lifecycle and registration requirements, including submitting documentation using the Common Submission Dossier Template format through the Pharmacy and Poisons Board's online portal. It describes risk-based classification of devices into Classes A, B, C and D and the various evaluation routes for registration based on a device's class and prior approvals in reference regulatory authorities. Exceptions for certain higher-risk devices are also noted. Contact information is provided for the Pharmacy and Poisons Board.

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REPUBLIC OF KENYA
MINISTRY OF HEALTH
PHARMACY AND POISONS BOARD
OVERVIEW OF GUIDELINE FOR REGISTRATION OF
MEDICAL DEVICES
DR PAULYNE WAIRIMU
25TH OCTOBER 2018
STAKEHOLDERS
SENSITIZATION AT PPB
BOARDROOM
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Outline of Presentation
• Introduction
• Scope
• Definitions of Medical Devices &IVD’s.
• Overview of the medical device life cycle and associated regulatory
activities
• Risk Based Classification
• Registration requirements
• Class A-listing of Medical Devices
• Class B, C&D
• Overviews & Summary
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Scope
• Medical Devices
• Accessories
• In-Vitro Diagnostics Medical Devices
• Research material
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Definition of Medical Device, IVD Medical
Device Cont:
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Medical technologies: semantics, purpose and material nature
Health technologies: purpose or application (examples)
Prevention: Vaccines, contraceptive devices, immunization, hospital infection control
programme, fluoridated water supply, iodized salt.
Screening: Pap smear, tuberculin test, mammography, serum cholesterol testing.
Diagnosis: Stethoscope, in vitro diagnosis, electrocardiogram, serological test for
typhoid, x-ray.
Treatment: Antiviral therapy, haemodialysis, coronary artery bypass surgery,
psychotherapy, medicines for pain, antibiotics.
Rehabilitation: Exercise programme for post-stroke patients, assistive device for severe
speech impairment, incontinence aid, hearing aid.

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Definition cont:
Health/medical technologies: material nature
Medicines: Chemically synthesized substances intended for use in the medical diagnosis, treatment, or
prevention of disease. Examples: acetylsalicylic acid, beta-blockers, antibiotics, antidepressants.
Biologics: Therapeutic substances derived from the human body or animals, and products of
biotechnology. Examples: vaccines, blood products, cellular and gene therapies.
Medical devices: A medical device is any instrument, apparatus, implement, machine, appliance, implant,
in vitro reagent or calibrator, software, material or other similar or related article that does not achieve its
primary intended action in or on the human body solely by pharmacological, immunological or metabolic
means.31 Examples: syringes, defibrillators, HIV in vitro tests, surgical instruments, hip prostheses,
linear accelerators.
Medical and surgical procedures: Psychotherapy, nutrition counselling, coronary angiography, gall
bladder removal. Support systems: Electronic patient record systems, telemedicine systems, medicine
formularies, blood banks, clinical laboratories.
Organizational and managerial systems: Prospective payment using diagnosis-related groups,
alternative health care delivery configurations, clinical pathways, total quality management programmes.
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Introduction
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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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Overview of the medical device life cycle and
associated regulatory activities
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Registration requirements
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• 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)
• Online portal of the ppb.

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CLASS A-LISTING OF MEDICAL
DEVICES
• This class of products will still undergo
reviewing through the listing process
• Ascertain the quality, safety and
performance
• The low risk associated with the products
will see the products reviewed at a faster
turn around time,
• The documents requested remain the
same
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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
• Bi-lateral agreements between regulatory
authorities
• 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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Evaluation routes based on Class of
Product based on CLASS B
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• Full Evaluation Route (FER)
• Abridged Evaluation Route(AER)
• Expedited Class B Registration (EBR)
Evaluation Route
• Immediate Class B Registration (IBR)
Evaluation Route

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Class C
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• No immediate registration route for this group of medical devices
• 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)- A medical device that has acquired
registration in atleast 3 RRA’s.
• Expedited Class C Registration (EBR) Evaluation Route- In addition to
device registered in atleast 5 RRA’s, no safety aleart should have been
reported.
• The following Class C devices are excluded from submission via the ECR
evaluation route:
• 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.

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Class D
• No immediate registration route for this group of
medical devices
• 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)- similar to Class C
• Expedited Class D Registration (EBR) Evaluation Route- Similar
to Class C.
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Class D
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• The following Class D devices are excluded from
being registered via EDR route:
• Active implantable devices (e.g. pacemakers,
neurostimulators)
• Implantable devices in direct contact with the central
circulatory system or central nervous system
• Hip, knee and shoulder joint replacement (e.g.
bioactive implants)
• Devices incorporating a registrable drug in an
ancillary role

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Exceptional classes of MD’s
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• A Medical Devices incorporating a
medicinal substance
• Drug eluting stents
• Dermal filler incorporating analgesic
• Antimicrobial silver dressings.

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Contacts
Pharmacy and Poisons Board
Box 27663-00506, Nairobi
–
Email: pwairimu@pharmacyboardkenya.org
– medicaldevices@pharmacyboardkenya.org

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Asante Sana
• Thank you • Merci Beaucoup
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