Ministry of Health:     

Ministry of Health

Regulatory Authority:          

Kenya Pharmacy and Poisons Board (PBB)

Medical Device Regulation:          

Pharmacy and Poisons Act, Cap 244 – Health Laws (Amendment) Act, 2019 (No. 5 of 2019)

Guideline for Registration of Medical Device

Other global regulatory regulations are also accepted

Official Language:      

Swahili, English

Classification:    

Class A,B,C,D

Registration Process:

• Fill up the application form and submit the filled-up required document together with all required documents.
• Pay the appropriate fees as advised by the board’s officers.
• Once your application is approved you will receive a Certificate evidencing the registration of the medical device.
• An applicant for a manufacturer outside Kenya must file evidence of Power of Attorney from the manufacturer which authorizes him to speak for his principal on all matters relating to the application. The application process usually takes a period of three months.

Documents Required:          

• Common Submission Dossier Template (CSDT)
• Letter of Authorization for Authorized Representative
• Device Labelling
• Pre-verification certificate for Notified Body
• IFU, Patient information leaflet, promotional material
• Certificate of Analysis
• Information on sterilization methods and validation standard
• Regulatory Approval from the country of origin
• QMS certificate

Additional for Class B, C and D

• Essential Principles Checklist
• Design verification and validation
• Risk Analysis
• Clinical Evidence

Applicable QMS:          

ISO 13485

Registration Timeline:         

Around 9-12 months

Authorized Representative:          

Yes

License Validity:          

5 years