To All Medical Device Establishments

After Compliments,

Sub: Guidelines for the Innovative Medical Device Guidance and Guideline for Electronic Instructions for Use

In reference to the Oman Sultani Decree No. 35/2015 which promulgated the law regulating the practice of the profession of pharmacy and pharmaceutical institutions and the Oman Ministerial Decision No. 113/2020 issuing the executive regulations for the law regulating the practice of the profession of pharmacy and pharmaceutical institutions.

Towards the enactment of the medical device and equipment regulation in Oman in accordance with the above-mentioned Ministerial Decision, we have published draft guidelines about the Innovative Medical Device Guidance and Guideline for Electronic Instructions for Use. The draft guidelines is uploaded in the MOH website and it is available in the link:

https://moh.gov.om/en/hospitals-directorates/directorates-and-centers-at-hq/drug-safety-center/#Section1

You can notify your comments, if any, on the draft guideline within a period of two months from the date of this Circular. Comments can be sent to this email: med-device@moh.gov.om

Thank you for your understanding and cooperation.