Medical Device Authorized Representative Registration is Mandatory Requirement to import Medical Devices in to the Kingdom of Bahrain.
FAST TRACK Authorized Representative Registration is an optional process (out-sourced by NHRA) available to applicants who have clearly defined projects, have the ability to prepare an application within the time period given and can respond to the ABC’s professionals with comments along with required documents. As a part of Fast Track Authorized Representative Registration Service, ABC will guarantee a review of the whole project and prepare Authorized Representative Registration application Gap-Analysis within 10 working days and will be delivered in writing and discussed in a virtual meeting within, 10 working days.
All Authorized Representative Registration applications in the Fast Track have the same application requirements and must meet the same standards as the normal applications process.
Therefore, all applicants must full fill all the requirements in the guidelines available on the NHRA website.
Once you agreed that, please follow the steps below:
1. Please find the attached NHRA Form and all guidelines of NHRA.
2. Request draft of engagement letter to ABC and the Invoice.
3. When you send us all required documents, we will send you the invoice or If you apply in the system you will have the option to make the payment online and you will receive the receipt.
4. When the payment is done, we will assign the application to one of our professional Bio-Medical Engineers.
5. All communication will be through emails/Online System to ensure the security and quality of work.
6. If there are any missing documents the process will be delay, so make sure you fully fill all requirements.
7. All documents can be sent by email, Online System or save in USB or any other suitable way and deliver it to ABC Office.