Circular No. (1) 2022 Date: January 19, 2022 To All Medical Devices Companies and Healthcare Facilities Subject: Cases that will not be included in the medical device's regulation Based on the resolution no (48) for the year of 2020, NHRA would like to clarify that the following medical devices will not be subjected to registration: 1 Medical device imported for healthcare facilities for: • Emergency • A single time and not planned to be imported on a regular basis 2 Medical devices imported for research and educational purposes. 3 Personal imported medical devices. 4 Custom-made medical devices or order for specific patient 5 Samples for exhibition and conferences. Facility registrations are not required for: medical device Authorized representative warehouses already licensed by Pharmaceutical Product Regulation section. For more information, you can contact the email below: medical_devices@nhra.bh