Medical Devices Regulation Division - IM-2251-LIC
Medical Devices & Supplies Control
Control of medical Devices
Requirements:
- Invoice including HS Code, Manufacturer Name and Country of Origin.
- Authorized Representative certificate.
- NHRA medical devices registration license, if not available please provide the below requirements:
- A. Product quality documents, (example: foreign government USFDA, CE), it should be issued by a recognized certifying body.
- B. Quality Management System (ISO 13485).
- C. All certificates provided should be verified and a verification proof should be provided as a screenshot in the application
- D. Catalog that should contain the imported product code / Ref No. of the product/s mentioned in the invoice.
- E. Label of the medical device should include name of the legal manufacturer.
Guidelines:
Medical devices
