MEDICAL DEVICE REGISTRATION AND APPROVAL IN Oman

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 update: January 2024

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 Ministry of Health.

CLASSIFICATION SYSTEM: Oman accepts all classification systems.

TIMEFRAME: the notification process takes 3-4 months.

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

AUTHORIZED REPRESENTATIVE: A local authorized representative is required.

ADDITIONAL INFORMATION: Currently the registration system is under development. The process now is a notification.

 

Other Middle East & North Africa Countries: Algeria,Bahrain,Egypt,Israel,Jordan,Kuwait,Lebanon,Morocco,Palestine,Qatar,Saudi Arabia,Tunisia,United Arabic Emirates,Yemen

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