The Saudi Food & Drug Authority (SFDA) has issued the “MDS-G024 Guidance,” aligning the global ISO 13485 standards with the regulatory framework of SFDA-MDS. This guidance is a significant step in clarifying the Quality Management System (QMS) requirements for medical device stakeholders in Saudi Arabia.
Key Highlights:
- The MDS-G024 document maps ISO 13485 standards to the corresponding SFDA-MDS requirements.
- It applies to manufacturers, authorized representatives, importers, and distributors handling medical devices in Saudi Arabia.
- Businesses can utilize this guidance as a certification framework to ensure their QMS complies with regulatory expectations.
- It emphasizes the importance of risk management and post-market surveillance as integral parts of the QMS.
- The guidance streamlines the process for organizations to align with both international standards and local regulatory requirements.
- Compliance with this document helps facilitate the approval process for medical devices in the Saudi market.
Benefits of Adhering to MDS-G024
Adhering to the MDS-G024 guidance provides several benefits for stakeholders in the medical devices sector. Firstly, it ensures that businesses meet the SFDA’s stringent regulatory requirements, which can reduce delays in product approvals. Secondly, it fosters a culture of quality and continuous improvement by aligning operational practices with globally recognized ISO 13485 standards. Finally, it enhances the credibility and competitiveness of organizations, boosting trust among healthcare providers and consumers in Saudi Arabia.
Why This Matters
This alignment aims to streamline compliance processes, ensuring medical devices in the Saudi market meet both international and local standards for safety and quality. Stakeholders like regulatory affairs professionals and manufacturers can now better understand what’s needed for seamless market access.
Simplify Your Compliance Journey
Managing SFDA and ISO 13485 requirements can be complex. Platforms like V-Apps.cloud offer a complete cloud-based solution to streamline compliance efforts, enhance data security, and improve workflow efficiency. With custom workflows, ISO-compliant document management, and predictive analytics, V-Apps.cloud is your partner in achieving hassle-free regulatory alignment.
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Managing SFDA and ISO 13485 requirements can be complex. Platforms like V-Apps.cloud offer a comprehensive cloud-based solution to simplify compliance efforts, enhance data security, and optimize workflow efficiency. With customized workflows, ISO-compliant document management, and predictive analytics, V-Apps.cloud is your partner for achieving regulatory alignment without stress.
Schedule a demo today to discover how it can revolutionize your business.