Approval to import a medical device through the Customs Single Window (Ofoq)

Required Attachments

• Invoice
• Device registration certificate
• Quality Certificate
• Certificate Verification
• Device manual

If the device is registered, the invoice and registration certificate are required, although the applicant may have to submit additional documents at the NHRA’s request:

• Classification certificate issued by the Classification Committee of the Medical Devices Department to prove that the imported product is a medical device or supply
• If the imported products are surgical instruments or contact lenses, the importer may be required to provide samples for examination. It may be necessary to inspect the shipment in customs to ensure the quality and conformity with the papers submitted through the Customs Single Window (Ofoq)

Legal Regulations

• Ministerial Resolution No. (48) of 2020 on Medical Devices and Products’ Quality Control

Fees

• 0.5 BD Per category : Request for approval to import a single device - Medical Device Registered
• 2 BD Per category : Request for approval to import a single device - Medical Device Not Registered
• 1 BD Per category : Request for approval to import a single device - Compact medical device Registered
• 3 BD Per category : Request for approval to import a single device - Compact medical device Not Registered
• 5 BD Per category : Verify the effectiveness of the quality certificate
• 20 BD Per category : Product classification request - ordinary
• 40 BD Per category : Product classification request - Urgent
• 100 BD Per day per shipment : Reservation of the device until approval
• 15 BD Per version : Issuance of product classification certificate
• 5 BD Per category : Sample examination
• 10 BD Per category : Inspection of the shipment at the custom port