Medical Device and Health Product Registration is mandatory in Kenya. Importing, manufacturing, or selling a medical device or health product without it is prohibited outright. The Pharmacy and Poisons Board (PPB), the National Regulatory Authority under the Pharmacy and Poisons Act (Cap. 244), controls this gateway. For medtech companies, device importers, and health-tech manufacturers entering the Kenyan market, understanding the registration pathway is not optional groundwork, it is the difference between a legal product and a seized shipment.

Legal Framework

Registration is governed by the Pharmacy and Poisons (Registration of Health Products and Technologies) Rules, 2022 (Legal Notice 100 of 2022, made under the Pharmacy and Poisons Act, Cap. 244), made under the Pharmacy and Poisons Act. The Rules commenced on 9 June 2022 and revoked the previous 1981 Registration of Drugs Rules. They cover a broad category, medicinal products, medical devices, in-vitro diagnostics, vaccines, blood products, cosmetics, food supplements, and borderline products, under a single registration framework.

Rule 3 is the operative prohibition: no person shall import, manufacture, or sell a health product or technology in Kenya unless it has been registered under these Rules.

Classification and Registration Pathway

Medical devices are classified by risk, Classes A through D, broadly mirroring the International Medical Device Regulators Forum (IMDRF) model. Class A devices (lowest risk) require only a listing-type registration. Classes B, C, and D require fuller evaluation, with the applicable route depending on whether the device already holds approval from a Reference Regulatory Authority (a reliance pathway) or requires full evaluation from scratch. Registration is processed through PPB’s online portal (PRIMS).

Application Requirements

An application is made to the Registrar on Form 1. Foreign applicants (non-citizens or companies incorporated outside Kenya) must appoint a local representative who is a Kenyan citizen, permanent resident, or Kenya-incorporated company. The application must be accompanied by:

• A proposed product label.
• The manufacturing licence, where applicable.
• A Good Manufacturing Practice certificate from both PPB and the country of manufacture’s regulator.
• A certificate of analysis from a PPB-recognised quality control laboratory, where applicable.
• The marketing authorisation or certificate of registration from the country where the product is sold.
• Quality, safety, efficacy, and performance data in a common technical dossier format.
• A physical sample of the product.
• Proof of ownership of the manufacturing site, if applicable.
• The local representative agreement, for foreign applicants.
• Proof of an underlying PPB licence (practising, wholesale dealer, poisons-dealing, or manufacturing licence, as applicable).
• Proof of payment of the prescribed fee.

The Board will register the product and issue a certificate (Form 2) if satisfied as to safety, efficacy, quality, performance, and economic value. If not satisfied, the Board must give the applicant an opportunity to be heard before rejecting the application, and must state its reasons in writing.

Fees

The Second Schedule prescribes fees in US Dollars, notably not Kenya Shillings, a detail worth flagging since most other CMA and CBK licensing fees in Kenya are denominated in Kshs:

• General health product registration: USD 1,000 (not manufactured in Kenya) or USD 500 (manufactured in Kenya).
• Renewal: same figures as registration.
• Fast-track evaluation (products not manufactured in Kenya): USD 2,000.
• Emergency Use Authorisation for medical devices and IVDs: USD 2,500.
• Medical Device Class A registration and renewal: USD 100.
• Medical Device Class B registration and renewal: USD 200.
• Medical Device Class C and Class D registration and renewal: USD 1,000 each.
• Food supplements, cosmetics, and borderline products: USD 500 (not manufactured in Kenya) or USD 100 (manufactured in Kenya).
• Traditional health products (locally manufactured): USD 50 registration, USD 20 renewal.
• Donated health products: no fee.

Validity, Renewal, and Retention

A certificate of registration is valid for five years from the date of issue. Registration holders must apply annually for retention on the register (Form 4), submitting product summary information, manufacturing site details, batch data, and any post-registration variations, accompanied by a valid GMP certificate and the retention fee. If a renewal application is submitted before the five-year period expires, the certificate remains in force pending the Board’s decision, avoiding a compliance gap while renewal is processed.

Emergency, Compassionate Use, and Unregistered Product Pathways

The Rules provide three narrower pathways outside standard registration:

• Emergency registration (rule 14): a provisional certificate valid for two years, available where necessary to protect public or animal health or in response to a threat to life or health.
• Compassionate use (rule 15): for patients with chronic or severely debilitating disease that cannot be satisfactorily treated with an already-registered product, or for clinical trial sponsors, subject to the manufacturer committing to supply the product for at least a year beyond the certificate period and to provide it free of charge during that period.
• Authorisation of unregistered products (rule 16): a narrower, person- or institution-specific authorisation for a specified quantity, requiring six-monthly progress reports and immediate adverse event reporting.

Suspension and Revocation

The Board may withhold, suspend, or cancel a registration where the holder misrepresented information, acquired the certificate fraudulently, breached the Act, the Rules, or a licence condition, where the product’s formulation or safety profile has changed materially, or where cancellation is in the public interest. The Board must issue a notice of intention (Form 5) and give the holder an opportunity to be heard before suspending or cancelling.

This is not a theoretical risk. A 2025 judicial review case, Republic v Pharmacy & Poisons Board; Prism Life Sciences Limited and Galaxy Pharmaceuticals Limited (High Court, August 2025), directly engaged these Rules, evidence that PPB’s registration and enforcement decisions are being actively tested in court, not just applied administratively.

This article is for general information and does not constitute legal advice. Product classification and the applicable registration pathway should be confirmed with PPB or counsel before submission, since misclassification can result in delay, rejection, or later suspension.

Regional Harmonisation on the Horizon

Kenya is party to ongoing efforts to harmonise medical device regulation across the East African Community, working toward a framework that would eventually allow a single registration to cover multiple EAC member states rather than requiring separate national filings in each. For companies planning a multi-country East African market entry, this is worth tracking, since a Kenyan registration obtained today under the current framework should remain the foundation even as regional harmonisation develops, rather than something to defer in anticipation of a unified process that is not yet in force.

In parallel, PPB is pursuing WHO Maturity Level 3 status, a formal international benchmark of regulatory capacity that Kenya’s Ministry of Health has explicitly linked to attracting greater pharmaceutical and medical device manufacturing investment. Companies evaluating Kenya as a manufacturing base, rather than purely an import market, should factor this regulatory maturation into their timeline, since it signals PPB’s registration and inspection processes are expected to become more rigorous and more internationally recognised over the coming years, not less.

Related Reading

This article is the first in our Life Sciences and Healthcare series covering Kenya’s regulatory landscape for medical device and health product companies. See our companion guides to digital health, telemedicine and medical device software regulation, and pharmaceutical manufacturing licensing and EPZ incentives, for how the Digital Health Act 2023 and PPB’s SaMD framework interact with device registration.

Registering a medical device or health product in Kenya, or planning market entry? Clay & Associates Advocates advises medtech and pharmaceutical companies on PPB registration, classification strategy, and regulatory compliance. Contact us to discuss your product.