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Does my medical device need PPB in-country IVD performance testing in Kenya?

Describe your device to check whether PPB in-country IVD performance testing 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 PPB in-country IVD performance testing check is screening

Checks listed products such as syringes, needles, gloves, condoms, implants, IUDs, and blood bags. Evidence is normally handled inside the medical-device registration route.

Requirement family: Product-specific compulsory conformity
Regulatory object: ivd or condom device
Maintained rule status: included in medical registration
Useful product facts: Exact product category, sterile/single-use status, materials, variants, and applicable product standard.

Section 2.15.2: in-country assessment for performance and evaluation is a mandatory pre-registration requirement for IVDs — samples with defined sample sizes must be submitted to the PPB Quality Control Laboratory department; an IVD that fails the performance-testing criteria will not be approved for registration; male latex condoms and other specified medical devices must also undergo laboratory testing.

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 →

Import CoC / PVoC

KEBS Pre-Verification or Certificate of Conformity

Handled as an import or shipment-level obligation.

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.