Service Directory

Medical device registration

NHRA receives requests for the registration of medical devices and supplies that must be reviewed and registered, before they can be marketed. A prior appointment must be booked, and an online application submitted in accordance with the provisions of Ministerial Resolution No. (48) of 2020.

Required Attachments

Application form
Technical specifications
Device identification card
Letter from the legal manufacturer disclosing relationship with actual manufacturer and name of invoice issuer
Usage instructions
List of countries where the device is marketed
Safety alarm records
Quality assurance certificate
Quality management system certificate
Sale permission certificate
Declaration of conformity including device safety level and GMDN code

Legal Regulations

Ministerial Resolution No. (48) of 2020 regarding quality control of medical devices and products

Fees

5 BD : Medical device registration - Request to submit a registration request Per device
150 BD : Medical device registration - Low risk device first registration First order
100 BD : Medical device registration - Low risk device Registration renewal annual
300 BD : Medical device registration - Medium risk device first registration First order
200 BD : Medical device registration - Medium risk device Registration renewal annual
1000 BD : Medical device registration - High risk device first registration First order
700 BD : Medical device registration - High risk device Registration renewal annual