Medical Device Registration in
Ghana
Ministry of Health
Regulatory 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