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.
For detailed device-specific compliance information for each market, including Oman, to expedite the preparation of your medical device or IVD registration application.
Any Questions?
Please fill out your contact information so we can better assist you.
* 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.