Competent authority
authority.competent-authority
Pharmacy and Poisons Board (PPB)
PPB · structured requirements
🇰🇪 Kenya medical device regulatory data
Explore the medical device requirements currently available for Kenya, organized by topic and linked to official sources.
6 facts5 dimensions3 official sourceslatest verification 2026-08-13
Legal basis & guidance
Which current law, regulation, guidance, and transition provisions apply?
Official legal and guidance surface
legal-basis.official-surface
- Authority
Pharmacy and Poisons Board (PPB)
- SubmissionSurface
PPB online services portal plus statutory Form 1 and dossier
- VerifiedHighlights
- The current rules contain the application, local-representative, dossier, variation, renewal, validity and fee structure.
- Medical-device certificates are valid for five years under the rules.
Official forms & portals
Which current form, portal, account, and submission package must be used?
Official form or portal surface
submission.official-form-or-portal-surface
- SubmissionSurface
PPB online services portal plus statutory Form 1 and dossier
- VerifiedHighlights
- The current rules contain the application, local-representative, dossier, variation, renewal, validity and fee structure.
- Medical-device certificates are valid for five years under the rules.
Registration pathways
Which registration, notification, listing, reliance, or conformity route applies?
Market-access route or official registration surface
registration.market-access-route
- SubmissionSurface
PPB online services portal plus statutory Form 1 and dossier
- VerifiedHighlights
- The current rules contain the application, local-representative, dossier, variation, renewal, validity and fee structure.
- Medical-device certificates are valid for five years under the rules.
Reliance & recognition
Which foreign decisions or evidence can be reused, with what effect and conditions?
Medical Device Single Audit Program — qms audit reliance
reliance.reliance-edge-mdsap-network-qms-reuse-program-mdsap-kenya
- Target
geo:ken
- SourceApproval
Medical Device Single Audit Program
- EdgeType
Qms Audit Reliance
- MarketAccessStrength
Evidence Only
- RegulatoryLayer
Qms Audit
- LocalApplicationRequired
Yes
- TargetDecisionRetained
Yes
Conditions
- medical devices and IVDs subject to route-specific scope
- usage differs by member framework
- does not create product authorization
- Canada requires MDSAP for Class II-IV ordinary licensing
WHO Prequalification of IVDs — collaborative abridged registration
reliance.reliance-edge-who-pq-ivd-to-crp43-program-who-pq-ivd-kenya
- Target
geo:ken
- SourceApproval
WHO Prequalification of IVDs
- EdgeType
Collaborative Abridged Registration
- MarketAccessStrength
facilitated
- RegulatoryLayer
Product Marketing
- LocalApplicationRequired
Yes
- TargetDecisionRetained
Yes
- TimeTargetDays
90
- TimeBasis
Working Days After Access To All Relevant Information
Conditions
- WHO-prequalified IVDs
- manufacturer opt-in and consent
- participating NRA
- same product in all essential features
- national requirements and fees remain
Need to apply Kenya's requirements to a product?
Confirm the current PPB pathway, evidence, and local-role details for the actual device before filing.