For Medical Device Classification steps, please follow the following:


1- Classification procedure must be done prior to importation or registration.

2- Not all medical devices require classification, it might be requested by importation/ registration team however there is a fixed list of Medical devices that require classification.

3- Applicant must first book and appointment then submit the form on the booked date to medical_devices@nhra.bh.

4- For further information regarding reference countries NHRA created list of the regulatory authorities website links and contact details for applicants reference.

5- Some products have specific requirement like the Biological products or devices used in Saloons were applicant can use the dedicated form and follow the same process of medical devices classification application,For more information please watch the video .

6- list of classified products as medical devices.

7- For further information about border line products classification, please visit Classification of Medical Devices Standards - GSO 2628:2021.