Medical Device Registration in
Ministry of Health:
Medical Device Regulation:
Food & Drugs Act, 1964 and Regulation 1975
- Submit the product information to the MoH for product evaluation
- PRA evaluates the application and a report will be issued.
- Register through MoH Trade System – apply for Import Permit
- If approved, PRA will sign and stamp the permit and assign it a unique number
- PRA issues the complete import permit.
- The medical device can now be marketed in Jamaica
- Certificate of Analysis
- 3 copies of Label
- 3 samples of the finished product
- Manufacturing processes and quality assurance programme
- Certificate of Good Manufacturing Practice (cGMP) as recommended by WHO
- Premarket Approval
- Package Insert
- Information brochure for patients which includes short-term and long-term risks.
Products should be in the international market for at least 1 year.