Responsibilities of a Medical Device Importer in Oman

1. Verification of CE Marking and Declaration of Conformity: Ensure the device has CE marking and declaration of conformity.

2. Correct Designation of Authorized Representative: Verify the device’s authorized representative.

3. Conformity of Labeling and Instruction for Use: Ensure labeling and instructions comply with Omani regulations.

4. Allocation and Registration of Unique Device Identifier (UDI): Verify UDI presence and registration.

5. Transport and Storage Conditions: Ensure compliance with manufacturer’s instructions and Omani regulations.

6. Cooperation with Manufacturer and Authorities: Collaborate in investigations with relevant parties.

7. Notification of Non-Conformity or Incidents: Inform manufacturer and authorities of incidents.

8. Appointing an Authorized Representative: Importer may act as an authorized representative, handling inquiries and coordinating with authorities and manufacturers.

9. Online Registration Process: Transitioning to an online registration process for medical devices in Oman to simplify and standardize procedures.