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.

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