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Oman Medical Device Regulations

Agency
The Ministry of Health (MOH) - Sultanate Oman, the Directorate General of Pharmaceutical Affairs and Drugs Control Medical Device Control Department (DGPA &DC) regulates medical devices in Oman.
Medical Device Definition
Medical device means any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material, or another similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more of the specific medical purpose(s) of:
  • Diagnosis, prevention, monitoring, treatment, or alleviation of disease.
  • Diagnosis, monitoring, treatment, alleviation of, or compensation for an injury.
  • Investigation, replacement, modification, or support of the anatomy or a physiological process.
  • Supporting or sustaining life.
  • Controlling of conception.
  • Disinfecting medical devices.
  • Providing information by means of in vitro examination of specimens derived from the human body; and does not achieve its primary intended action by pharmacological, immunological, or metabolic means, in or on the human body, but which may be assisted in its intended function by such means.
Medical Device Classification System
  • It should be according to the Country of origin Jurisdiction and it may be subject to reclassification at a later stage.
  • In Oman, they Classify the product in regards to their severity in general to Low Risk, Medium-High Risk, and High Risk, and they will accept the classification as per the following table:
Severity Class Risk Level
Low Class A Class I
Low-Moderate Class B Class II/Class IIa
Moderate-High Class C Class IIb/Class III
High Class D All other Class III/Class IV/AIMD
Approval Process Pre-Market Approval Procedure “Listing Procedure”:
Registration of Medical Devices in Oman is still not implemented (Published Guidelines for the registration are still Draft guidelines). Medical devices shall only be imported, placed on the market, and/or put into service within the Oman market if it is listed in medical device control department databases.
List of Required Documents Steps to do the listing:
  1. Appoint Omani Authorized Representative.
  2. Open MOH Website: https://www.moh.gov.om/en/home
  3. Go to DGPA&DC files from the home page of the MOH website.
  4. From the Medical Device bottom, you need to download the Excel sheet "It is an example sheet" for uploading data of Medical Devices (Establishments & Products) information.
  5. After filling data, you will send the Excel file to the following e-mail: dgpa-it@moh.gov.om
  6. Periodically, not more frequently than annually, requesting each listing party to confirm that the information provided for listing purposes continues to be accurate.
Additional Information
Approval timeline The timeline and fees for the Medical Devices provided services by the MOH of Oman are still not announced.
License validity period The registration process is still not implemented so there is no Registration Certificate validity announced and the applicant shall follow the listing procedure to import Medical Devices in Oman.
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