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Does my medical device need KEBS Pre-Verification or Certificate of Conformity in Kenya?

Describe your device to check whether KEBS Pre-Verification or Certificate of Conformity may apply, why, what facts are missing, and which official source to review.

3 maintained routes1 official source links

Preliminary applicability · country-specific scope

What you receive

Not just a yes or no

A route-by-route answer. Separate product certificates, dossier evidence, import documents, and facility licences stay separate.

Trigger reasoning. See which product facts matter and which missing facts prevent a reliable conclusion.

Official starting points. Open the regulator or government sources behind the maintained country matrix.

Maintained country rule

What this KEBS Pre-Verification or Certificate of Conformity check is screening

Separates reusable product approval from consignment, customs, PVoC, CoC, and HS-code documents. Handled as an import or shipment-level obligation.

Requirement family: Import conformity and shipment certificates
Regulatory object: class a listing or import
Maintained rule status: mandatory at import
Useful product facts: HS code for every shipped object, shipment purpose, importer, origin, product certificate, and consignment details.

Class A listing requires a Pre-Verification certificate from a Notified Body in liaison with KEBS (Kenya Bureau of Standards); a Certificate of Conformity is also acceptable in place of PVoC (Table 4 item 3).

How to read the answer

Classification is only the first layer

A device may have one medical risk class and still trigger separate radio, electrical, measurement, radiation, environmental, import, or installation requirements. The checker keeps each regulatory object separate.

Product approval

A certificate or approval attached to the finished product, component, or radio host.

Dossier or import evidence

Testing can belong inside the medical dossier, while some documents apply to each shipment.

Site or operator licence

Radiation, installation, use, or measurement controls may apply to a facility or operator.

Country-specific scope

Other Kenya routes to check

Check every Kenya route →

Product-specific

PPB in-country IVD performance testing

Evidence is normally handled inside the medical-device registration route.

Product-specific

PPE certificate of analysis and ISO 10993-1

Evidence is normally handled inside the medical-device registration route.

Official starting points

Use these authority pages to confirm current scope, technical rules, application routes, and transition dates. A linked source does not turn a preliminary result into an authority decision.

Pharmacy and Poisons Board (PPB)

registration guidelines — in-country IVD testing, KEBS pre-verification, PPE certificate of analysis

About this checker

A preliminary tool, not a regulatory determination

Describe the complete product — radio, power, measurement, radiation, battery, materials, accessories, intended use, import route, and existing approvals. The free checker maps those facts to the maintained Kenya scheme matrix and links each route to its official source.

Use the result to identify questions and official sources. Final scope can depend on exact models, modules, bands, components, claims, HS codes, import structure, installation site, and current authority interpretation.

Is this the same as medical device classification in Kenya?: No. Risk classification determines the main medical-device pathway. This checker runs after classification and looks for additional product certificates, dossier evidence, import documents, and facility or operator licences.
Does “no separate certificate” mean no testing is required?: No. Safety, EMC, performance, or other evidence can still be required inside the medical-device dossier even when there is no separate national product certificate.
Is the result an official regulatory determination?: No. It is a preliminary applicability assessment. Review the linked official source and confirm the final route with the relevant authority, certification body, importer, or regulatory professional.