The US Food and Drug Administration (FDA), Australian Therapeutic Foods Administration (TGA), Brazilian Health Surveillance Agency (ANVISA), and the Canadian Health Products and Food Branch (Health Canada) have all signed on to a statement of cooperation to develop a single audit program for medical devices.
The intent is to make their respective quality management system auditing processes more efficient by establishing the Medical Device Single Audit Program (MDSAP). Upon implementation of the MDSAP program, the audit of a medical device manufacturer’s quality system in any one of the four participating countries will meet regulatory requirements of all four countries—a significant move that could ease medical device company’s paths to market.
Among the MSDAP’s stated objectives are promoting work-sharing arrangements and mutual acceptance among participating regulators to allow more efficient and flexible use of resources among the FDA, Health Canada, ANVISA, and TGA regarding medical device quality system audits, standardizing participants’ market oversight practices regarding third-party auditing entities, and leveraging existing conformity assessment structures when appropriate.
