The Saudi Food & Drug Authority (SFDA) has released a new document titled:
“MDS-G024 Guidance for ISO 13485 Requirements and Corresponding SFDA-MDS Requirements.“
This guidance is designed to align the ISO 13485: 2016 Quality Management System (QMS) requirements with SFDA-MDS regulations, offering a streamlined approach for medical device compliance in Saudi Arabia.
Who Should Use This Guidance?
This document provides essential clarifications for various stakeholders involved in the placement of medical devices in Saudi Arabia, including:
- Manufacturers
- Authorized Representatives
- Importers
- Distributors
By harmonizing ISO 13485 with SFDA-MDS regulations, the guidance offers a structured framework that can be utilized as a basis for certification of Quality Management Systems (QMS). Establishments operating within the Saudi medical device market can leverage this document to enhance their compliance strategies, ensuring their processes meet both international and local regulatory expectations.
Stakeholders are encouraged to review this guidance thoroughly to facilitate smooth market access and maintain adherence to Saudi regulatory standards.
Key Aspects of SFDA Issues New ISO 13485 Guidance – MDS -G024
- Integration of ISO 13485:2016 with SFDA Regulations: The guidance meticulously maps the clauses of ISO 13485:2016 to corresponding SFDA Medical Devices Sector (MDS) requirements. This alignment assists establishments in understanding how international QMS standards correlate with local regulatory obligations.
- Detailed Clarifications: For each clause of ISO 13485:2016, the document provides specific explanations on how it should be interpreted and implemented in the context of Saudi regulations. This includes additional SFDA expectations and any deviations from the international standard.
- Applicability to Various Establishments: The guidance is relevant to a broad range of entities involved in the medical device lifecycle, including manufacturers, authorized representatives, importers, and distributors. It outlines the responsibilities of each entity type concerning QMS implementation and compliance.
Impact on Medical Device Companies
Companies already compliant with ISO 13485 will need to review their QMS to ensure alignment with SFDA-specific requirements. For manufacturers entering the Saudi market, MDS-G024 acts as a guideline for structuring their QMS to meet SFDA expectations.
How OMC Medical Can Help
OMC Medical specializes in regulatory compliance and QMS implementation for medical device companies. Our team can assist with:
- QMS Gap Analysis – Identifying areas where your system may need adjustments to align with SFDA-MDS.
- SFDA Registration Assistance – Ensuring smooth submission and approval for your medical devices.
- Regulatory Consultation – Keeping your team up to date with Saudi regulatory requirements.
For more details on how we can support your compliance efforts, feel free to reach out to us!
