By Stewart Eisenhart, Emergo Group
The medical device regulators of Australia, Brazil, Canada and the US have all signed on to a statement of cooperation to develop a single audit program for medical devices to be used by all four market authorities.
The US Food and Drug Administration (FDA), Australian Therapeutic Foods Administration (TGA), Brazil’s ANVISA and Health Canada intend to make their respective quality management system auditing processes more efficient and less burdensome 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 in these regions.
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.
The statement of cooperation included no information on possible implementation timeframes for MDSAP, but it’s fair to assume participating regulators will need a fair amount of time to align their resources and technologies to begin developing the program. Emergo Group will provide further details as we learn them.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.