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PPB · Middle East & Africa

Kenya medical device regulatory resources

Every Kenya dataset, comparison, and AI workpaper we maintain — one entry point for the whole market.

5 free resources23/25 topics with recordsAug 2026 fees reviewed
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Medical device regulation news

Follow recent Pharmacy and Poisons Board (PPB) policy, guidance, safety, and compliance updates.

AI medical device classifier

Describe your device and get a preliminary PPB risk class with official rule references.

Government registration fees

Review current PPB application, review, and renewal fees.

Registration timeline

The three PPB marketing-authorisation pathways and the periods the Board publishes for each.

Structured regulatory requirements

Explore all 61 source-linked facts →

23 of 25 research dimensions currently covered · 16 official sources · latest verification 2026-09-16

Market entry

D01

Authority & regime

Verified
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…
1 source-linked fact
Checked 2026-08-25
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D02

Legal basis & guidance

Verified
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…
1 source-linked fact
Checked 2026-08-25
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D03

Device definition & scope

Verified
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…
Medical device software framework
PPB has issued a Guideline on Regulation of Medical Device Software in Kenya (MDSW) covering Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD), with risk classific…
3 source-linked facts
Checked 2026-08-25
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D04

Classification rules

Verified
Risk classes A through D for devices and IVDs (PPB registration guidelines).
Class A, Class B, Class C, Class D
1 maintained scheme · 4 related facts
Checked 2026-08-25
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D05

Registration pathways

Verified
Abridged route - Class B
A Class B medical device that has obtained at least two reference regulatory agency approvals for a labelled use identical to that intended for marketing in Kenya qualifies for the abridged…
Abridged route - Class C and D
A Class C or D medical device qualifies for the abridged evaluation route if it has obtained at least three reference regulatory agency approvals for a labelled use identical to that intend…
8 source-linked facts
Checked 2026-08-25
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D06

Reliance & recognition

Verified
China NMPA approval: not a PPB reference regulatory agency (eight-agency list)
statement: PPB's abridged, expedited (EBR/ECR/EDR) and immediate (IBR) evaluation routes are available only to devices already approved by PPB's listed medical device reference regulatory a…
China NMPA approval: outside PPB reliance-guideline reference categories
statement: PPB's Guidelines on Reliance Mechanisms (HPT/PER/GUD/091 Rev 0, January 2025) enumerate the reference authorities and institutions PPB relies on: WHO PQ/CRP/EUL, SRAs, WHO Listed…
6 source-linked facts
Checked 2026-09-15
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D07

Economic-operator roles

Verified
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…
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…
2 source-linked facts
Checked 2026-08-25
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D08

Establishment, import & distribution

Verified
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…
2 source-linked facts
Checked 2026-08-25
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D09

Dossier requirements

Verified
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…
2 source-linked facts
Checked 2026-08-25
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D10

Official forms & portals

Verified
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…
1 source-linked fact
Checked 2026-08-25
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Submission & evidence

D11

Label, IFU & language

Verified
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…
1 source-linked fact
Checked 2026-08-25
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D12

QMS, audit & inspection

Verified
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…
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…
2 source-linked facts
Checked 2026-08-25
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D13

Standards, testing & ancillary approvals

Unresolved
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
3 maintained overlays
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D14

Fees

Verified
Imported device registration - Class A
USD 100
Imported device registration - Class B
USD 200
13 maintained fee lines · 1 related fact
Checked 2026-08-25
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D15

Review clocks

Unresolved
All classes — first in, first out · PPB marketing authorisation, default queue
2-2.3 years
All classes — fast track (reliance route) · PPB marketing authorisation, priority queue
4-5 months
All classes — expedited review (emergency use authorisation) · PPB emergency use authorisation
25-48 days
3 maintained pathways · 2 related facts
Checked 2026-08-30
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D16

Approval validity & renewal

Verified
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…
3 source-linked facts
Checked 2026-08-25
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Lifecycle & post-market

D17

Change control

Verified
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…
Changes requiring a new application
Certain changes do not qualify for change notification and require submission of a new CSDT application, including: change to the intended purpose of a registered medical device; change to…
3 source-linked facts
Checked 2026-08-25
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D18

UDI, listing & traceability

Verified
A national UDI assigned by the PPB is a defined medical-device field in the national traceability dataset
statement: The A&T standard's product dataset for medical devices includes a 'Unique Device Identification (UDI)' field described as a series of alpha numeric characters assigned by the PPB…
Unit-level serialization is mandatory for medicines; medical devices appear only in the Phase 4 rollout bullet
statement: Kenya's national authentication and traceability standard imposes the mandatory unit level unique identifier rule on medicines. Section 2.2 (Standards) requires all serialized un…
3 source-linked facts
Checked 2026-09-16
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D19

Clinical investigation & performance

Verified
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…
2 source-linked facts
Checked 2026-08-25
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D20

Special access & derogation

Verified
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…
2 source-linked facts
Checked 2026-08-25
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D21

Manufacturer PMS

Verified
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…
2 source-linked facts
Checked 2026-08-25
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D22

Vigilance & incident reporting

Verified
Investigation and other event deadlines: 15 and 30 days
The manufacturer must investigate serious events and submit investigation reports to the Board as soon as possible but not later than 15 days; all other reportable events must be reported a…
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…
4 source-linked facts
Checked 2026-08-25
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D23

Recall, FSCA & market surveillance

Verified
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…
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…
2 source-linked facts
Checked 2026-08-25
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D24

Advertising, claims & promotion

Verified
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,…
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…
2 source-linked facts
Checked 2026-08-25
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D25

Submission communications & appeal

Verified
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…
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…
2 source-linked facts
Checked 2026-08-25
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Government fees

Full fee schedule (13 lines) →

PPB registration fees in USD · reviewed 2026-08-25

Fee lineAmountProvenance
Imported device registration - Class AUSD 100Verified
Imported device registration - Class BUSD 200Verified
Imported device registration - Class C/DUSD 1,000Verified
Locally manufactured registration - Class A/BUSD 50Verified
9 more fee lines on the full schedule · 13 of 13 rows source-verified

Registration timeline

Full registration timeline →

Pharmacy and Poisons Board (PPB) review clocks and planning ranges · 4-class (A, B, C, D) — EU-aligned classification

Class / pathwayReview clockPlanning totalProvenance
All classes — first in, first out(PPB marketing authorisation, default queue)2-2.3 years2-2.5 yearsVerified
All classes — fast track (reliance route)(PPB marketing authorisation, priority queue)4-5 months5-9 monthsVerified
All classes — expedited review (emergency use authorisation)(PPB emergency use authorisation)25-48 days1-3 monthsVerified
  1. 1Pre-Submission Preparation(1-3 months)
  2. 2Application Submission(1-2 weeks)
  3. 3Administrative Review(2-4 weeks)
  4. 4Technical Evaluation(2-2.3 years)
  5. 5Registration Approval(1-2 weeks)
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