Kenya Medical Device Regulation

Navigating Medical Device Regulations in Kenya: PPB Guidelines, Registration Process, and Compliance 

Regulatory Authority

Kenya Pharmacy and Poisons

The Pharmacy and Poisons Board is the Drug Regulatory Authority established under the Pharmacy and Poisons Act, Chapter 244 of the Laws of Kenya.

The Board regulates the Practice of Pharmacy and the Manufacture and Trade in drugs and poisons.

The Board aims to implement the appropriate regulatory measures to achieve the highest standards of safety, efficacy and quality for all drugs, chemical substances, and medical devices, locally manufactured, imported, exported, distributed, sold, or used, to ensure the protection of the consumer as envisaged by the laws regulating drugs in force in Kenya.

Link for Regulatory Authority

https://web.pharmacyboardkenya.org/

Local Regulation

https://web.pharmacyboardkenya.org/legal-provisions-guidelines-procedures/ 

Classification of Medical Devices 

Class A, B, C and D 

Listing or Registration Requirements 

All devices need to be registered via the Online Portal of the Pharmacy and Poisons Board. There are three pathways for submitting an application i.e. First in first out (FIFO), Fasttrack (full assessment and Reliance) and expedited pathway (emergency use authorization). 

Documents Required for Kenya Medical Device Registrations

• Administrative information
• Manufacturer name and address
• Types of marketing clearances or approvals from each country/region
• Local Authorized Representative and Subcontractors
• Device identification; classification
• Related previous submissions; Accessories
• Sales, complaints, and vigilance
• Draft Declaration of Conformity
• Essential Principles Checklist
• Manufacturing process and subcontractors
• User information
• Design verification and validation
• Risk management; Clinical evaluation
• PMS and PMCF
• Biological safety
• Sterilization validation
• Software
• Packaging
• Shelf life and stability testing 

Registration Timeline

New Registration (full and abridged evaluation route) will take up to 12 months 

Registration Fee

Payment of requisite administration fees of 100 USD 

License Validity

Licenses granted in Kenya have a validity period of five years, necessitating an annual retention process. 

Import permit

To import new medical devices, importers must secure a medical device registration certificate from the Pharmacy and Poisons Board (PPB). The PPB also issues import permits for each consignment of medical devices. The processing of these import permits is facilitated through the Kenya National Trade Net System (KESWS).

Additional Information

Class A medical devices necessitate only listing.

For Class B, C, and D medical devices, the applicable routes are as follows:

• Full Evaluation Route
• Abridged Evaluation Route
• Expedited Evaluation Route
• Immediate Evaluation Route

The full evaluation route is suitable for a medical device lacking prior approval from any Reference Regulatory Agencies at the time of application.

The abridged, expedited, and immediate evaluation routes are structured based on a confidence-driven methodology, utilizing approvals from listed medical device reference regulatory agencies (8) and/or a documented history of safe marketing.

Who should make this Communication?

• Manufacturer
• Authorized Representative
  

When to make this Communication?

Before placing a medical device into the market.

How OMC Medical can assist you with the Process?

Why Choose Us?

• Working towards client satisfaction
• Cost effective solutions
• Project completion before deadline
• Quality Regulatory affairs solutions

Contact us for free consultation: info@omcmedical.co.uk