Medical devices regulation in Kenya rests primarily with the Pharmacy and Poisons Board (PPB) and the Kenya Bureau of Standards (KEBS), which operate alongside each other rather than as alternatives. The PPB’s authority over devices flows from the same Pharmacy and Poisons Act (Cap 244) and Registration of Health Products and Technologies Rules, 2022 that govern medicines. A manufacturer or importer that treats a device as a lighter-touch product than a medicine because it is not a drug is starting from the wrong assumption.
Medical Devices Regulation in Kenya: What Counts as a Device
The Act defines “health product” to include human and veterinary medicines, medical products, vaccines, diagnostics, medical devices, blood products, cosmetics and related products. It defines a “medical device” broadly, as an instrument, apparatus, implant, in vitro reagent or calibrator, software, material or similar article intended by the manufacturer to be used for humans or animals for purposes such as diagnosis, prevention, monitoring or treatment. Software is therefore expressly within the definition, and businesses bringing digital health tools into Kenya should not assume the framework applies only to physical hardware. The 2022 Rules also define an in-vitro diagnostics medical device, as a device intended for the in vitro examination of specimens from the human body to provide diagnostic, monitoring or compatibility information.
Registration Requirements
Under rule 3 of the 2022 Rules, no person may import, manufacture or sell a health product or technology in Kenya unless it has been registered. Rule 4 requires an application in Form 1 accompanied by, among other things, a proposed label, the manufacturing licence where applicable, a good manufacturing practice certificate, the marketing authorisation or registration from the regulator of the country where the product is sold, and data on quality, safety, efficacy and performance in a common technical dossier format. The Board must be satisfied of the product’s safety, efficacy, quality, performance and economic value before registering it.
Where the applicant is not a Kenyan citizen or is a company incorporated outside Kenya, rule 4(2)(b) requires the appointment of a local representative, who must be a Kenyan citizen, a person with permanent residence, or a company incorporated in Kenya, and a copy of the appointing agreement must accompany the application. This gives the PPB a Kenya-based point of accountability for the device once it is on the market.
Post-Market Surveillance and Vigilance
Registration is not the end of a manufacturer’s or importer’s obligations. Rule 4 makes the holder of the certificate of registration responsible for the labelling, packaging, advertising and pharmacovigilance system of the product, and the application dossier itself contemplates vigilance and product safety reports, including product complaints and market surveillance. The Act defines post-market surveillance as monitoring the safety and quality of a product after release, and the Board may recall medical products from the market under section 3A. Build the capability to track which units went where, and to reach affected customers or facilities, before the first unit is sold.
KEBS Standards Compliance
KEBS operates under the Standards Act (Cap 496), separately from the PPB. Under section 9, the Council may declare a Kenya Standard, and the Cabinet Secretary may by gazetted order prescribe a date after which no person may manufacture or sell a commodity to which that standard relates unless it complies. Inspectors have powers under section 14 to enter premises, take samples and require production of records. A device can therefore be fully registered with the PPB and still face a standards problem if it falls within a compulsory standard, which is why the two tracks should be managed in parallel from the start of a market entry plan.
Importation Controls and Appeals
Importation is a distinct strand of medical devices regulation in Kenya. Section 3A of the Pharmacy and Poisons Act empowers the Board to grant or withdraw licences to importers, exporters, wholesalers, manufacturers and distributors, so map PPB registration, the relevant import licence and any KEBS requirement against the actual shipment timeline. A gap in any one of them can hold inventory at the border.
A refusal or revocation is not necessarily final at the Board’s level. Under the Act’s licensing provisions, the Board may refuse to issue or renew, or may revoke, a licence for good and sufficient reason, with an appeal to the Cabinet Secretary whose decision is final. Understand this route before a refusal happens, not after the letter arrives.
Advertising and Penalties
Section 39 of the Act prohibits advertisements referring to a drug, medicine, medical appliance or similar article in terms that the Board considers extravagant and bearing little or no relation to its pharmacological properties. Under section 40, a first conviction for breaching the advertising provisions carries a fine of up to KES 20,000 or imprisonment for up to one year, or both, and a subsequent conviction a fine of up to KES 30,000 or imprisonment for up to two years, or both. Offences for which no other penalty is provided attract, under section 51, a fine of up to KES 1,000,000 or imprisonment for up to two years, or both, together with possible forfeiture of the articles involved.
Practical Compliance Guidance
For a first-time entrant, medical devices regulation in Kenya in practice means a sequence that runs PPB registration, appointment of a local representative where the applicant is foreign, review against any compulsory KEBS standard, and import licensing, managed as overlapping workstreams rather than a single linear process. A business already navigating pharmaceutical regulation in Kenya should expect substantial procedural overlap, but not identical requirements, when it adds a device to the same portfolio.
How We Can Help
Clay & Associates Advocates advises medical device manufacturers, importers and distributors on PPB registration strategy, local representative arrangements and the interaction between PPB and KEBS requirements at market entry. Our guide to KEBS standards compliance covers the standards side in more detail. See our life sciences and healthcare practice or contact us to map the requirements that apply to your device.
Sources: Pharmacy and Poisons Act (Cap 244), sections 3A, 39, 40 and 51; Pharmacy and Poisons (Registration of Health Products and Technologies) Rules, 2022, rules 3 and 4; Standards Act (Cap 496), sections 9 and 14.
Frequently asked questions
Does software count as a medical device in Kenya?
Yes. The Pharmacy and Poisons Act definition of “medical device” expressly includes software intended by the manufacturer for diagnosis, prevention, monitoring or treatment.
Do foreign manufacturers need a local representative?
Yes. Rule 4(2)(b) of the 2022 Rules requires a local representative where the applicant is not a Kenyan citizen or is a company incorporated outside Kenya.
Is PPB registration enough to sell a device in Kenya?
Not necessarily. Importers need the relevant licence, and a device may also fall within a compulsory Kenya Standard under the Standards Act.
Can a PPB licensing decision be challenged?
Under the Act’s licensing provisions, a refusal or revocation of a licence carries an appeal to the Cabinet Secretary, whose decision is final.
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This article is general information on Kenyan law as at its publication date, not legal advice. Reading it does not create an advocate and client relationship.
