Registration & Licensing of Medical Device & Supply Establishments

Our Services Include

1. 1 Creating and activating establishment and importer accounts on SFDA platforms and systems.
2. 2 Issuing licenses for medical device and supply establishments (importer/distributor).
3. 3 Issuing Authorized Representative licenses for medical devices and supplies.
4. 4 Issuing medical device and supply warehouse licenses, whether private warehouses or third-party storage arrangements.
5. 5 Issuing medical device maintenance center licenses.
6. 6 Preparing and reviewing documents and requirements needed for licensing.
7. 7 Assisting in obtaining ISO 13485 certification for the medical device and supply quality management system.
8. 8 Renewing establishment and warehouse licenses and completing the necessary requirements.
9. 9 Submitting and following up on licensing applications with the relevant authorities.
10. 10 Addressing comments and completing requirements until licensing procedures are fulfilled.