By GARR Staff
September 5, 2025
The Medical Device Single Audit Program (MDSAP) has long been a cornerstone for streamlining regulatory compliance across multiple markets. In June 2025, the program unveiled its newly redesigned global website, mdsap.global, offering a more intuitive and accessible platform for manufacturers, auditors, and regulators alike.
🔍 What Is MDSAP?
MDSAP permits a recognized Auditing Organization (AO) to enable a single regulatory audit of a medical device manufacturer’s quality management system (QMS) to satisfy the requirements of multiple regulatory authorities listed below. This consolidated approach reduces audit fatigue, accelerates market access, and fosters international regulatory harmonization.
- United States – FDA
- Canada – Health Canada
- Brazil – ANVISA
- Japan – PMDA/MHLW
- Australia – TGA The decision-making body of the MDSAP is the MDSAP RAC or Regulatory Authority Council. The RAC governs and provides direction to support MDSAP development and expansion. Similar to the structure of IMDRF, the medical device regulatory harmonization organization, MDSAP also has Official Observers and Affiliate Members and a number of informational and technical documents on its website.
✳️Key Features of the New MDSAP Global Website
Centralized Access to Regulatory Information
The revamped site centralizes resources from all five participating regulatory authorities, providing manufacturers with a one-stop destination for guidance documents, audit procedures, and regulatory updates.
Enhanced User Experience
Designed with user feedback in mind, the new platform boasts a clean, modern design that facilitates faster access to essential information. The site is optimized for improved accessibility across devices, ensuring users can navigate with ease.
Updated Resources and Training Materials
Manufacturers and auditors can now access updated audit guides, FAQs, and training materials, ensuring they are well-equipped to meet the evolving requirements of the MDSAP.
Regular Updates on Policies and Procedures
The website features a dedicated news section that provides regular updates on policies, audit procedures, and other pertinent information, keeping stakeholders informed of the latest developments.
✅ Benefits of the MDSAP Global Website
- Streamlined Compliance: Manufacturers can navigate the complexities of international regulations through a unified platform, simplifying the compliance process.
- Resource Efficiency: The centralized access to resources reduces the time spent searching for information, allowing stakeholders to focus on core activities.
- Global Market Access: By adhering to a single set of audit criteria recognized by multiple regulatory authorities, manufacturers can expedite market entry across participating countries.
🗣️ Looking Ahead
The launch of the new MDSAP global website marks a significant step toward enhancing regulatory efficiency and collaboration in the medical device industry. As the program continues to evolve, stakeholders are encouraged to explore the new platform and leverage its resources to navigate the complexities of global medical device compliance.
For more information and to access the new website, visit mdsap.global.
📚 References
- (n.d.). Medical Device Single Audit Program (MDSAP). https://www.mdsap.global/about
- MDSAP membership Types. (n.d.). Medical Device Single Audit Program (MDSAP). https://www.mdsap.global/about/membership