Chapter 1 Kenyan PPB Administration Information Abstract

1. Administration and Abstract

The administration for the registration of medical devices in Kenya is the Pharmacy and Poisons Board (PPB). The committee is mainly responsible for market access, compliance assessment and post-marketing supervision of medical devices.

2. Administrative Regulation

[Pharmacy and Poisons Act] 

3. Risk Level Classification of Medical Device and IVD Products

Medical Device:

IVD：

4. Entry Requirements

ISO13485 certificate

Appointment of a Local Authorized Representative (LAR) in Kenya.

Registration documents: administrative information, classification information, Declaration of conformity draft, risk management, clinical assessment, PMS and PMCF, etc.

5. Registration Language

English.

6. Authorized Representative for Kenya (LAR)

Manufacturers outside Kenya must appoint a Local Authorized Representative (LAR) to communicate with the Kenya Pharmacy and Poisons Board (PPB). The manufacturer must provide written authorization to prove that the authorized representative is acting with its consent, and the authorized representative must obtain an authorization letter from the manufacturer to clarify its rights.

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

Chapter 2 Registration Flow, Cycle & Official Fee

1. Registration Flow

2. Cycle & Official Fee

The unit of fee is USD

Registration Cycle:

New registration (complete and streamlined assessment process) takes approximately 12 months (Wiselink 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.