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Kenyan Medical Devices Regulatory Authority

Medical devices in Kenya are uniformly regulated by the Pharmacy and Poisons Board (PPB). The core responsibilities include: approval of market entry for medical devices, assessment of product compliance, supervision of production and import processes, post-market quality monitoring, and management of adverse events.

Regulatory Authority's Official Website Link:https://web.pharmacyboardkenya.org/

Administrative Regulation

[Pharmacy and Poisons Act]

Risk Level Classification of Medical Device and IVD Products

Medical devices are classified into four categories based on risk levels: Class A, Class B, Class C, and Class D. The risk levels increase in order:

In vitro diagnostic (IVD) products are also classified into four risk classes: Class A, Class B, Class C and Class D.

Entry Requirements

① Provide a valid ISO 13485 Quality Management System certificate;

② Appoint a local authorized representative (LAR) in Kenya;

③ Submit complete registration documents: administrative information, product classification details, draft conformity statement, risk management report, clinical evaluation report, post-market surveillance (PMS), and post-market clinical follow-up (PMCF) plans.

Registration Language

English.

Local Authorized Representative (LAR) System

Manufacturers located outside Kenya must appoint a Local Authorized Representative (LAR) to handle all communications with PPB regarding registration. The manufacturer must provide a written authorization letter clearly outlining the representative's rights and responsibilities.

A manufacturer may appoint only one authorized representative in Kenya for the same product line or product range.

Registration Flow, Cycle & Official Fee

1. Registration Flow

Standard process: Product risk classification and preparation of registration documents → Appointment of a local authorized representative in Kenya → Submission of the registration application via the CSDT template and payment of official fees → Technical review and assessment conducted by PPB → Approval decision (issuance of registration certificate or rejection with reasons) → Post-registration management including renewal and amendments, along with compliance with annual reviews and adverse event reporting requirements.

2. Cycle & Official Fee

The unit of fee is USD

Registration Cycle:

The standard cycle for new registrations (including both full assessment and simplified assessment processes) is approximately 12 months (based on Wiselink's actual project experience).

Chapter 3 FAQ

Q: Which medical devices are exempt from registration in Kenya?

A: All medical devices sold in Kenya need to be registered, including devices containing medicinal products, customized devices, etc. The registration requirements are determined according to their risk classification. The risk level ranges from Class A to Class D, and different registration processes and standards apply to different categories.

Q: What documents does it require to submit for registration?

A: CSDT template should be used to submit, including administrative information, manufacturer information, local authorized representative information, technical document summary, etc., different categories of devices also need to provide additional specific documents such as authorization letter, label and so on.

Q: What are the evaluation paths for medical device registration?

A: Class B devices have comprehensive audit, simplified evaluation, rapid registration and Instant registration; Class C and D devices have comprehensive audit, simplified evaluation, and rapid evaluation paths.

Q: How to register medical devices containing medicinal products?

A: If the main mode of action is a drug, it is regulated as a drug.

Q: How long is the validity period of the Kenyan Medical Device Registration Certificate?

A: The general validity period is 5 years, but for some special cases, such as a device with a registration validity period of 2 years, it is implemented according to special provisions, and the registration needs to be renewed according to the procedure before the expiration of the validity period.

Q: How should medical devices be changed?

A: According to the type of change: minor changes only need to submit a change notice, major changes (such as changes in design, raw materials, intended use, etc.) need to submit a new CSDT format application.

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