Oman - Top Medical Device Alerts

08/11/2022

Begin the process of pilot registration of Medical Devices and Supplies. Circular: To notify all medical device establishments to start the pilot registration of Medical Devices and Supplies which are high risk and have Medical device marketing authorization (MDMA) in Saudi Arabia as of date 01/09/2022.

01/21/2021

Guidance Document GD3:Requirements of Moderate -High &High Risk Medical Devices Registration in Sultanate of Oman This guidance document is meant to assist applicants in the registration of moderate-high & high risk medical devices and medium-high devices in the Sultanate of Oman.

01/21/2021

Guidance Document GD 5: Requirements of Moderate-High & High-Risk In-Vitro Diagnostics devises Registration in Sultanate of Oman This guidance document is meant to assist applicants in the registration of moderate –high & high risk In-vitro diagnostics devices in the Ministry of health in Oman.

01/21/2021

Guidance Document GD 9: Requirements of Low Risk Medical Devices Registration in Sultanate of Oman This guidance document is meant to assist applicants in the registration of low risk medical devices in Sultanate of Oman.

01/21/2021

Guidance Document GD7: Requirements of Low-Risk In-Vitro Diagnostics Registration in Sultanate of Oman. This guidance document is meant to assist applicants in the registration of low-risk In-Vitro Diagnostic devices in the Sultanate of Oman.

*Note:

The guidelines were published, reviewed, and validated on 21/01/2021, but the final approval is pending as the Medical Devices registration procedure is not yet in place in Oman.

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