Medical Device Registration and Approval in Oman

General country-specific regulatory information is provided on this page for medical device registration and approval in Oman. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, including Oman, to expedite the preparation of your medical device or IVD registration application.

Medical Device Regulations and Classification in Oman

REGULATORY AUTHORITY: In Oman, medical devices are regulated by the Directorate General for Pharmaceutical Affairs and Drug Control, under the Ministiry of Health.

CLASSIFICATION SYSTEM: Oman accepts all classification systems.

TIMEFRAME: The approval process can take up to two years.

LICENSE VALIDITY: Licenses issued in Oman expire after five years.

AUTHORIZED REPRESENTATIVE: A local authorized representative is required.

Last updated on March 17 2015.

Other Middle East & North Africa Countries:

Algeria, Bahrain, Egypt, Israel, Jordan, Kuwait, Lebanon, Morocco, Palestine, Qatar, Saudi Arabia, Tunisia, United Arabic Emirates , Yemen

Submit inquiry


* Note: If you use your general ISP e-mail address, such as gmail, yahoo etc. your LinkedIn profile address is required to process your request.

Request a personal demo of Licensale.com

*Same day demos are not available