Get In Touch:

Jamaica

Medical Device Registration in Jamaika

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.

Want to know more about this registration process?