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Exporting from KSA — Certificate Requirements

Overview​

Manufacturers producing medical devices in Saudi Arabia and exporting to international markets need to understand both SFDA obligations for domestically manufactured devices and the requirements of the destination market.

SFDA Certificate of Free Sale / Export Certificate​

For medical devices manufactured in Saudi Arabia and intended for export, the SFDA may issue an export certificate (sometimes called a Certificate of Free Sale or Certificate of Conformity for export) confirming:

  • The device is legally manufactured and (if applicable) registered in Saudi Arabia
  • The manufacturer holds a valid MDEL
  • The device complies with applicable SFDA requirements

Request process: Export certificates are applied for via the GHAD portal or SFDA e-Services. Provide details of the device, destination country, and purpose.

Do exported devices need MDMA?​

  • If the device is also sold on the Saudi domestic market, it requires MDMA regardless of export status.
  • If the device is manufactured in KSA solely for export and will not be sold locally, it may qualify for an export-only exemption from MDMA. Confirm with the SFDA via your AR.

Destination market requirements​

Exporting from Saudi Arabia does not satisfy the regulatory requirements of the destination country. Each market has its own registration process:

DestinationKey registration requirement
EUCE marking under EU MDR/IVDR
USAFDA 510(k), PMA, or De Novo clearance/approval
UKUKCA marking under UK MDR 2002
AustraliaARTG inclusion via TGA
Other GCCSeparate national registration (see GCC Harmonisation)

A Saudi-based manufacturer can serve as the legal manufacturer on regulatory submissions worldwide, including EU MDR technical files, FDA submissions, and TGA applications. The SFDA MDMA (if held) and the manufacturer's ISO 13485 certificate from an accredited CAB support these submissions as evidence of manufacturing quality compliance.

Practical steps for export-focused manufacturers​

  1. Obtain MDEL (manufacturer category) from SFDA via GHAD
  2. Certify QMS to ISO 13485 from an SFDA-accredited CAB or IAF-accredited CB
  3. Determine whether MDMA is required (domestic sale vs export-only)
  4. Obtain SFDA export certificate for destination market requirements
  5. Engage regulatory consultants in destination markets for local registration

Further reading​