Ministry of Health: 

Ministry of Health and Wellness

Regulatory Authority:       

Pharmaceutical and Regulatory Affairs (PRA)

Medical Device Regulation:

Food & Drugs Act, 1964 and Regulation 1975

Official Language:   

English

Classification:        

Not Defined

Registration Process:       

• 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

Documents Required:      

• 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.

Special Notes:       

Products should be in the international market for at least 1 year.