On March 25, 2025, a guidance document was issued to provide compliance instructions on ISO 13485:2016 Medical Devices-Quality Management System-Requirements (ISO 13485) for medical device manufacturers, authorized representatives, importers, and distributors, considering the regulatory documents issued by the Saudi Food and Drug Authority (SFDA) Medical Devices Sector (MDS).
Manufacturers, importers, and distributors of Category A and B medical devices must obtain a certificate demonstrating compliance with the medical device Quality Management System (QMS) requirements in accordance with Saudi standards (SFDA.MD/GSO ISO 13485) or an equivalent standard.
Authorized representatives importers, and distributors of Category C and D medical devices must submit supporting documents providing compliance with the QMS requirements based on Saudi standards (SFDA.MD/GSO ISO 13485:2017) or an equivalent standard, or obtain an inspection report issued by the SFDA.
This guidance aims to help understand the key concepts of ISO 13485 to establish a compliant medical device Quality Management System (QMS) and to explain how these requirements are applied under the KSA Medical Devices Law and its implementing regulations.
As described above, medical device manufacturers, authorized representatives, importers, and distributors in Saudi Arabia must hold an ISO 13485 certification.
The appointment of an ISO 13485:2016 certified authorized representative is crucial for medical device registration and export in Saudi Arabia. JNM Korea provides ISO 13485-certified authorized representative services for medical device registration and export in Saudi Arabia.
Please refer to the attached document below.
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