Medical Device and Health Product Registration with the Pharmacy and Poisons Board

Medical device registration in Kenya is mandatory. Under the Pharmacy and Poisons (Registration of Health Products and Technologies) Rules (Legal Notice 100 of 2022), no person may import, manufacture or sell a health product or technology in Kenya unless it has been registered. The Pharmacy and Poisons Board (PPB) administers the register. For medtech companies, device importers and health-tech manufacturers, the registration pathway is the gateway to the market, and getting it wrong can mean delay, rejection or later cancellation.

The legal framework for medical device registration

The Rules were made under the Pharmacy and Poisons Act (Cap. 244), were published in Kenya Gazette Vol. CXIV, No. 112 on 17 June 2022, and commenced on 9 June 2022. They revoked the Pharmacy and Poisons (Registration of Drugs) Rules (LN 147 of 1981). Rule 3 is the operative prohibition: a person shall not import, manufacture or sell a health product or technology in Kenya unless it has been registered under the Rules.

The Rules cover medicinal products, medical devices, in-vitro diagnostic devices, vaccines and other health products under one registration framework. The Rules price registration by device Class A, B, C and D, so settle classification with PPB early.

Who can apply and what must be filed

Under rule 4, a person who intends to import, manufacture or sell a health product applies to the Board on Form 1. The applicant must name a person with appropriate knowledge of all aspects of the product to handle communications with the Board. An applicant who is not a Kenyan citizen, or is a company incorporated outside Kenya, must appoint a local representative who is a Kenyan citizen, a permanent resident, or a Kenyan-incorporated company, and must notify the Board of any change to that agreement within seven days.

The application must be accompanied by:

• a proposed label and, where applicable, the manufacturing licence;
• a good manufacturing practice certificate from the Board and from the regulator in the country of manufacture;
• a certificate of analysis from a laboratory recognised by the Board, where applicable;
• the marketing authorisation or certificate of registration from the country where the product is sold;
• quality, safety, efficacy and performance data in common technical dossier format, and a product sample;
• proof that the applicant holds a qualifying licence under the Pharmacy and Poisons Act, such as a practising licence (section 9A), wholesale dealer’s licence (section 27) or manufacturing licence (section 35A); and
• proof of payment of the Second Schedule fee.

Under rule 5, the Board registers the product and issues a Form 2 certificate if satisfied of its safety, efficacy, quality, performance and economic value. It may reject an application only after giving the applicant an opportunity to be heard, with written reasons.

Registration fees for devices

The Second Schedule sets fees in US dollars, not Kenya shillings. For devices, the registration and renewal fees are USD 100 for Class A, USD 200 for Class B, and USD 1,000 each for Classes C and D. Emergency Use Authorisation for a device or in-vitro diagnostic costs USD 2,500, and fast-track evaluation of a product not made in Kenya costs USD 2,000. Donated health products attract no fee.

Validity, retention and renewal

Under rule 10, a certificate of registration or renewal certificate is valid for five years from the date of issue. If a renewal application is submitted before the five years expire, the certificate stays in force until the Board decides it. Separately, rule 8 requires the holder to apply every year, on Form 4, to retain the product on the register. The retention application must be accompanied by a valid good manufacturing practice certificate and the retention fee, and a rule 9 renewal must include clinical and non-clinical study reports and vigilance reports.

Emergency, compassionate use and unregistered products

Three narrower pathways sit outside standard registration.

Rule 14 lets the Board issue a provisional certificate where necessary to protect public or animal health or in response to a threat to life or health. It is valid for two years from issue, or until the declaration made under section 35 of the Public Health Act is revoked.

Rule 15 allows registration for compassionate use, for a person whose application under rule 4 is pending or for a clinical trial sponsor. The manufacturer must supply the product for at least one year after the certificate period and must provide it free of charge during that period.

Rule 16 allows the Board to authorise the import or distribution of a specified quantity of an unregistered product to a specified person or institution. The holder must file progress reports every six months and report adverse events as they occur.

Suspension, cancellation and the courts

Under rule 11, the Board may withhold, suspend or cancel a registration where, for example, the holder misrepresented information, obtained the certificate fraudulently, breached the Act, the Rules or a certificate condition, or the product has changed so that it is unsuitable for registration, or where it is in the public interest. Before suspending or cancelling, the Board must issue a notice of intention on Form 5 and give the holder an opportunity to be heard.

The risk is real. In Republic v Pharmacy and Poisons Board; Prism Life Sciences Limited (Interested Party); Galaxy Pharmaceuticals Limited (Ex parte Applicant) [2025] KEHC 12028 (KLR), Galaxy Pharmaceuticals challenged a PPB notice of intention to cancel the registration of forty health products under rule 11(1)(b). The High Court struck out the application on 15 August 2025 as moot because the registrations had since been cancelled. Galaxy then filed a fresh application, and in Republic v Pharmacy and Poisons Board and another; Galaxy Pharmaceuticals Ltd (Ex parte Applicant) [2026] KEHC 4863 (KLR), decided on 15 April 2026, the High Court quashed the notice of intention dated 26 March 2025 and the cancellation decision of 22 May 2025, and ordered the registration certificates for the forty products reinstated, finding among other things that the Board had refused to give reasons. We have not checked whether that decision is under appeal. The lesson is to respond to a rule 11 notice immediately, insist on reasons, and frame any challenge around the decision actually taken.