Kenya medical device regulatory resources

Competent authority

The Pharmacy and Poisons Board (PPB) is the national regulator for medical devices and IVDs in Kenya, established under section 3 of the Pharmacy and Poisons Act (Cap. 244); section 3B(1) m…

Official legal and guidance surface

Binding regime: Pharmacy and Poisons Act (Cap. 244) and the Pharmacy and Poisons (Registration of Health Products and Technologies) Rules, 2022 (L.N. 100 of 2022), which contain the applica…

Medical device definition

Kenya applies a GHTF style definition: a medical device is any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use or calibrator, software, material or o…

IVD definition

An in vitro diagnostics medical device is defined in the 2022 Registration Rules as a device intended by the manufacturer for the in vitro examination of specimens derived from the human bo…

Risk classes A through D for devices and IVDs (PPB registration guidelines).

Class A, Class B, Class C, Class D

Registration required before marketing

All medical devices including in vitro diagnostic medical devices must be registered with PPB prior to placing them on the Kenyan market, unless exempted by the Regulations.

Class A listing process

Class A medical devices are registered through a listing type review: documents are submitted via the PPB online portal (prims.pharmacyboardkenya.org), the application fee is charged immedi…

Recognized reference regulatory agencies

The medical device registration guideline recognizes marketing clearances from eight listed reference regulatory agencies: Australia TGA, Health Canada, EU Notified Bodies (MDD/AIMDD/IVD Di…

Reliance mechanisms guideline

PPB's Guidelines on Reliance Mechanisms for Marketing Authorization apply to all health products and technologies including medical devices: PPB may base part or all of its regulatory decis…

Local representative mandatory for foreign applicants

Under rule 4(2)(b) of the 2022 Registration Rules, an applicant who is not resident in Kenya (foreign manufacturer) must appoint a local representative who is a citizen of Kenya, a person w…

Local Authorized Representative regime

PPB registers all Local Authorized Representatives (LAR) for medical devices in Kenya; only one LAR may be identified and this must be consistent across device labels and Declarations of Co…

Medical device establishments registration

Manufacturers, importers and distributors of medical devices in Kenya are regulated through registration of medical device establishments under the Pharmacy and Poisons Act; establishments…

Import/export licensing and permit controls

Under sections 3A(e) and 3B(2)(e) of Cap. 244 the Board grants or revokes licences for the manufacture, importation, exportation, distribution and sale of medicinal substances. Import/expor…

CSDT dossier format mandatory

Product registration applications for medical devices submitted to PPB must be prepared in the Common Submission Dossier Template (CSDT) format, which is based on the IMDRF STED guidance; a…

Five-year sales, complaints and vigilance data

Applicants must provide sales, complaints and vigilance data for the last five years, including full details of vigilance issues and the status of any Field Safety Corrective Actions or Not…

Official forms and portal

Applications are submitted through the PPB online portals: PRIMS (prims.pharmacyboardkenya.org) for marketing authorization and establishment applications, with an invoice generated upon co…

English labelling accepted

For the registration dossier it is sufficient to show labelling information in English only, but items to be translated and the translation plan should be indicated; legible versions of all…

QMS evidence accepted

Applicants must provide proof of a Quality Management System, e.g. an ISO 13485 certificate, conformity to US FDA Quality System Regulations (certificate of free sale), Japan MHLW Ordinance…

GMP inspection prerequisite

Before submitting an application for marketing authorization of medical devices or IVDs, the applicant must first apply for GMP inspection, per the PPB GMP inspection and compliance procedu…

PPB in-country IVD performance testing

Product-specific

KEBS Pre-Verification or Certificate of Conformity

Import CoC / PVoC

PPE certificate of analysis and ISO 10993-1

Product-specific

Imported device registration - Class A

USD 100

Imported device registration - Class B

USD 200

All classes — first in, first out · PPB marketing authorisation, default queue

2-2.3 years

All classes — fast track (full assessment or reliance) · PPB marketing authorisation, priority queue

4-5 months

All classes — expedited review (emergency use authorisation) · PPB emergency use authorisation

25-48 days

Registration valid five years

A certificate of registration is valid for 5 years from the date of issue (rule 10(1), L.N. 100 of 2022; also section 2.12 of the registration guideline). In an emergency situation or in th…

Renewal application and continuation in force

Renewal of registration is applied for using Form 4 (First Schedule) and must comply with the prescribed guideline for re registration and renewal; if a renewal application is filed before…

Changes require approval before supply

Changes to a registered medical device that can affect its safety, quality or efficacy must be approved prior to the modified device being supplied in Kenya, unless otherwise indicated; app…

Statutory variation duty

Under rule 13 of the 2022 Registration Rules the Board may, by written notice, vary the certificate and enter the variation in the Register; certificate holders must report any quality and…

No source-verified answer is published for this dimension yet.

Clinical evaluation required for all devices

Clinical evaluations are required for all medical devices; if a pre market clinical investigation has been conducted the documentation should be provided, and supporting evidence must be pr…

Post-registration clinical data condition

For devices registered via the Immediate Class B Registration (IBR) route whose labelled use goes beyond the inherent performance of the device, additional clinical data may be requested po…

Emergency Use Authorization

PPB grants Emergency Use Authorization (EUA) as a risk based expedited pathway for products addressing urgent threats such as pandemics, epidemics and chemical, biological, radiological and…

Authorization of unregistered products

PPB's Guideline on Evaluation and Authorisation of Unregistered Health Products and Technologies provides a route for accessing unregistered products urgently required to address unmet pati…

MAH safety monitoring and lifecycle QMS

Marketing authorization holders must monitor the safety of their products on the market and comply with pharmacovigilance; the manufacturer must establish, document and maintain throughout…

Qualified Person for Pharmacovigilance

PPB requires marketing authorization holders to nominate a Qualified Person for Pharmacovigilance (QPPV) a 'Final Notice on Nomination of QPPV' was issued to MAHs and local technical repres…

Reportable device adverse event criteria

The manufacturer, directly or through its authorized representative, must report to the Board adverse events associated with medical devices that occurred in Kenya when: (a) an event has oc…

Serious event reporting deadline: 2 days

Adverse events that result in unanticipated death, unanticipated serious injury, or represent a serious public health threat must be reported to the Board immediately and not later than 2 c…

FSCA reporting and Field Safety Notices

The manufacturer must report to PPB in a timely manner, directly or through its authorized representative, any Field Safety Corrective Actions it is undertaking within Kenya; Field Safety N…

Board recall and regulatory powers

Regulatory actions taken by the Board on device safety may include recalling the device, reclassifying it, or ordering a redesign from the manufacturer or another; the Board may request the…

Advertisement requires Board permission

Under section 36(1) of the Pharmacy and Poisons Act (Cap. 244), no person shall advertise any drug or poison except with the written permission of the Board; related provisions (ss.37 39) p…

Advertisement guideline covers devices

PPB's Guideline for Advertisement and Promotion of Health Products and Technologies covers medicines and medical devices; it sets out elements of advertisement and promotion, restrictions,…

Rejection and suspension decisions require hearing

Under rule 5(5) of the 2022 Registration Rules the Board may only reject an application after providing the applicant an opportunity to be heard, and must inform the applicant of the reason…

Appeals within 30 days in writing

Under section 42B of the Pharmacy and Poisons Act, appeals against specified decisions (under ss. 27(2), 28(3), 32(5), 50(2)) shall be in writing and lodged within thirty days after the dat…