Manufacturers Invited to Join Medical Device Single Audit Program Pilot

Medical device manufacturers worldwide recently were invited to participate in a single quality audit program to streamline inspections. The pilot program aims to minimize disruption in manufacturing operations and simplify the process of meeting similar regulatory requirements across borders.

Starting Jan. 1, global manufacturers that market to Australia, Brazil, Canada, and the United States can join the Medical Device Single Audit Program (MDSAP) pilot, according to a U.S. Food and Drug Administration (FDA) blog post. Companies that market to Japan also are invited to participate when the country joins the MDSAP group this summer.

“Under this pilot, audits will be conducted by recognized third-party organizations, and medical device regulators in the participating countries will be able to use these inspection reports when making their regulatory decisions,” Kim Trautman, associate director of international affairs at the FDA’s Center for Devices and Radiological Health (CDRH), wrote in the blog.
Launched in January 2014, the pilot program allows regulators to save resources when conducting inspections while retaining access to relevant information. For companies, the program minimizes manufacturing and personnel disruptions because they undergo fewer inspections.

Under the program, regulatory bodies in member countries can use third-party audits in lieu of their own inspections of manufacturers’ quality systems and practices.

“The FDA will accept MDSAP audits as a substitute for routine FDA inspections, typically done every two years for all classes of medical devices and including in-vitro diagnostic devices. Pre-approval inspections for devices requiring premarket approval applications (PMAs) and “for cause” compliance inspections will not be part of the MDSAP pilot,” Trautman added in the blog post.
According to a separate FDA article, the other regulatory bodies participating in the pilot include the Therapeutic Goods Administration of Australia, Brazil’s Agência Nacional de Vigilância Sanitária, and Health Canada. Japan’s Ministry of Health, Labour, and Welfare and the Japanese Pharmaceuticals and Medical Devices Agency currently are observers until the summer, when they will officially join the multilateral program.

“Manufacturers that choose to participate in the pilot program will help to shape the policies and procedures of the fully operational MDSAP, which is scheduled to begin in 2017. We expect that the MDSAP pilot will enhance confidence in third party audit programs, increasing the footprint of this global endeavor,” Trautman wrote in the blog post.

The MDSAP program is based on the international standard for medical devices quality management systems (ISO 13485:2003), the Brazilian Good Manufacturing Practices (RDC ANVISA 16/2013), the U.S. Quality System Regulation (21 CFR Part 820), and other specific pre- and post-market regulatory requirements of the authorities that are members of the group, according to the FDA blog post.

The medical device quality audit program was launched in 2012 by the International Medical Device Regulators Forum (IMDRF). The goals of the international initiative include pooling resources and ensuring the safety of medical devices being marketed to the public. A working group fleshed out the details of the program in 2013, and allowed third-party auditing organizations to begin conducting MDSAP audits for medical device manufacturers in June 2014.