General country-specific regulatory information is provided on this page for medical device registration and approval in Oman.
We review our Regulatory Information frequently; please check back often for updates
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.
For detailed device-specific compliance information for each market, including Oman, to expedite the preparation of your medical device or IVD registration application.
Did you know you can onboard your medical device or IVD compliance information to our system in less than 15 minutes?
And, in less than a minute, you can start your device-specific registration application and a complete county-specific registration process in this country or any of the other 140+ countries available for you through the Arazy Group Medtech registration platform.
