Medical device registration applications must be submitted through the Madar system by an establishment registered with NHRA as a Medical Device Authorized Representative.

To register a medical device, please follow the steps below:

1- The applicant must first be registered with NHRA as a Medical Device Authorized Representative.

2- Review the Medical Device Registration Guideline and prepare all documents required for the application.

3- Submit the complete application and all supporting documents through the Madar system.

4- Once the application reaches the payment stage, a payment notice will be issued through the system. The applicant must pay the applicable application fees and registration fees to proceed with the application.

5- The applicant will receive the registration decision through the Madar system. Approved medical devices will be published on the List of Registered Medical Devices.

6- In accordance with Circular No. (19) of 2026, medical devices must be registered by the following deadlines:

        • 30 April 2027: Class IIa, Class IIb and Class III medical devices, Class B, Class C and Class D in vitro diagnostic medical devices, and devices with equivalent medium risk or high risk classifications.

        • 31 July 2027: Class I medical devices, Class A in vitro diagnostic medical devices, and devices with equivalent low risk classifications.

Related Guidelines and References

• Circular No. (19) of 2026: Mandatory Medical Device Registration Deadlines

• Circular No. (1) of 2022: Cases Exempted from Medical Device Registration

• List of Emergency Use Approved Medical Devices

• Medical Device Registration Service Level Agreement

• MDD to MDR Transition Guideline

• Quality Assurance Certificate Verification Process Guideline

• Medical Device Labelling Guideline