To All Medical Device Establishments

After Compliments,

Sub: Commencement of Registration of High-Risk Medical Devices and Supplies Manufacturers and Their Products

In reference to the Oman Ministerial Decision No. 113/2020 and in accordance with its provisions to regulate the Medical Device and Supplies, would like to notify all medical device establishments to start the registration of Medical Devices and Supplies Manufacturers and their high-risk products and Shipment release will not be allowed as of the date 01/07/2026.

Accordingly, we request all Medical Device Establishments to do the needful for submitting the Technical Files for high-risk products through MOH online portal at least two months prior to the arrival of the shipment. The Drug Safety Centre is not responsible for any delay in custom clearance unless the registration process is completed.

We would also like to inform you that medical device registration service is active, therefore, those who wish to voluntary register are kindly requested to do so through the Ministry of Health's Portal.

The registration requirements can be found at the following link:

https://moh.gov.om/en/hospitals-directorates/directorates-and-centers-at-hq/drug-safety-center/