To register medical devices, please follow the steps below:
1. Medical devices registration is going to be mandated by the 1st of February 2026.
2. In order to register medical devices, applicants must be registered as medical devices authorized representatives.
3. Before submitting medical devices registration applications, applicants should list all devices by submitting the listing form to firstname.lastname@example.org.
4. Medical devices registration process is done through Ajheza system by booking an appointment and submitting all required documents at the booked date and time on the system.
5. For fast-track application submissions, NHRA have recognized conformity assessment bodies: Medspero Company and ABC company.
6. Fees will be applied and notice to pay will be sent to applicants Ajheza system.
7. Approvals will be sent to applicants through Ajheza system and devices will be published on the List of registered medical devices.
List of Emergency Use approved medical devices
· NHRA Medical Devices registration process
Slides of latest Medical device registration presentation (17 Aug 2022)
QAC verification process guidelineMedical Device Labelling guideline
Medical Devices Violations guideline
For more information on Ajheza system, please visit Ajheza system page