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 medical_devices@nhra.bh.
4. Medical devices registration process is done through booking an appointment and submitting the form and all required documents to medical_devices@nhra.bh at the booked date and time.
5. For fast-track application submissions, NHRA have recognized conformity assessment body: Medspero Company.
6. For fast-track application electronic submissions, NHRA have recognized conformity assessment body: ABC company.
7. Fees will be applied and notice to pay will be sent to applicants by email.
8. Approvals will be sent to applicants by email and devices will be published on the List of registered medical devices.
Other resources:
·
NHRA Medical Devices registration process
QAC verification process guideline
Medical Device Labelling guideline
Medical Devices Violations guideline