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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.

Last updated on November 24th, 2021.
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.
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