Ministry of Health

Ministry of Health Ghana

Regulatory Authority

Ghana Food and Drug Authority

Medical Device Regulation

Public Health Act, 2012, Act 851

Official Language

English, Akan

Classification

Classes I, II, III, and IV

Registration Process

• Determine the device classification
• Appoint an Authorized Representative
• Submit the Technical documentation to the Ghana FDA
• Once approved, the product can be marketed in Ghana.

Documents Required

• Cover letter
• Power of Attorney
• Product Description
• Technical Documentation
• Evidence of Conformity to Essential Principles
• Device Specifications
• Device Verification and Validation
• Biocompatibility (if applicable)
• Software Verification and Validation (if applicable)
• Devices Containing Biological Material (if applicable)
• Pre-clinical Studies (if applicable)
• Clinical Evidence (if applicable)
• Risk Analysis
• Manufacturing Information

Applicable QMS

ISO 13485

Registration Timeline

6 months

Authorized Representative

Yes

License Validity

3 years