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Maldives

Medical Device Registration in 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.

Documents Required:          

  • Application Form
  • LoA for Authorized Representative
  • Manufacturer Information
  • Product Information
  • Previous regulatory approvals
  • Conformity Assessment certificate by a Notified Body
  • Declaration of Conformity
  • CE mark

Applicable QMS:          

ISO 13485

Authorized Representative:          

Yes

Special Notes:    

Product samples may be asked at the time of application.

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