For Local Manufacturing facility Registration process, please follow the below steps:

1.Fill out Medical Devices Local Manufacturing facility application Form.

2. Make sure you have all required documents for the registration. For more information please refer to Medical Devices Manufacturing Facility Requirements and Guideline.

3.Once all the required documents are ready, apply for Non active CR (for new Medical devices manufacturing facilities ie; does not have medical device manufacturing CR activity).

4.To submit the application for NHRA review, please book an appointment on Microsoft bookings where a notice to pay will be issued based on NHRA fees. Remark: capture from the booked appointment should be attached with the email.

5. All documents should be sent via email to medical_devices@nhra.bh at the date and time booked.

6.Once the application is reviewed and the initial approval is granted, NHRA team will set a date and time for the inspection.

7.Prepare the facility for the final approval based on inspection requirements, once ready book an appointment to submit the requirements. Remark: capture from the booked appointment should be attached on the email

8.Once inspection is done and final approval is obtained after fulfilling inspection requirements, applicant should complete the payment process to obtain the registration certificate & once obtained, submit it on sijilat system.