To register a local medical devices manufacturing facility, please follow the steps below:

1- Complete the Medical Devices Local Manufacturing Facility Application Form.

2- Ensure that all required documents are available before submitting the application. For further information, please refer to the Medical Devices Local Manufacturing Facility Registration Guideline.

3- If the Commercial Registration (CR) is newly established and does not yet include any activity, apply for a non-active CR through Sijilat.

4- Submit the completed application form and all required supporting documents to NHRA by email at medical_devices@nhra.bh.

5- Pay the applicable application fee. NHRA will begin reviewing the application and supporting documents once the payment has been completed.

6- Once NHRA grants the initial approval, the applicant must upload it to the Sijilat system to obtain the corresponding initial approval for the application submitted through Sijilat.

7- Following the initial approvals in both NHRA and Sijilat, the applicant may proceed with preparing the facility for inspection in accordance with the inspection requirements.

8- Once the facility is ready, complete the inspection request form and submit it by email to medical_devices@nhra.bh. The NHRA team will then confirm the inspection date and time.

9- Following the inspection, the applicant must fulfil any outstanding inspection requirements. Once all requirements have been met and final approval has been granted, the applicant must complete the applicable payment process to obtain the facility registration certificate.

10- After receiving the facility registration certificate, which serves as NHRA’s final approval and licence, the applicant must upload it to the Sijilat system to complete the process and activate the relevant medical device manufacturing activity under the Commercial Registration.