Maldives

Ministry of Health:     

Ministry of Health

Regulatory Authority:          

Maldives Food and Drug Authority

Medical Device Regulation:          

The Maldives does not have a defined regulation for medical devices. It does accept medicinal products regulated by major global regulatory authorities, along with few more supporting documents.

Official Language:      

Maldivian, English, Arabic

Classification:    

Not Defined

Registration Process:

• Appoint an Authorized Representative
• Prepare the application form and required documents for Medical Device Import License.
• AR submits the application to the regulatory authority
• Once Import License is issued, the medical device can be marketed in the Maldives.