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ISO 13485:2016 is an internationally recognized standard that specifies requirements for a QMS where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and applicable regulatory requirements.

ISO 13485 is based on ISO 9001 but is specifically tailored for the medical devices sector. It includes additional requirements for regulatory compliance, risk management, sterile products, and device-specific documentation not found in ISO 9001.

The Saudi Food and Drug Authority (SFDA) recognizes ISO 13485 as part of its medical device registration process. Manufacturers holding ISO 13485 certification from accredited certification bodies benefit from a more streamlined regulatory approval pathway.

Medical device manufacturers, component suppliers, distributors, importers, contract manufacturers, and service providers (sterilization, packaging) involved in the medical device supply chain benefit from ISO 13485 certification.

The EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) require a quality management system aligned with ISO 13485 as part of the conformity assessment process required for CE marking.