Sep 9, 2016

Officials overseeing the Medical Device Single Audit Program (MDSAP) developed to allow single quality system audits across multiple regulatory jurisdictions have issued an official request for participation to medical device manufacturers ahead of the program’s full implementation deadline.

The invitation notes that after January 1, 2017, a device manufacturer may choose to undergo a quality system audit by an MDSAP-authorized auditing organization; market applicants' audit results will be recognized by the US Food and Drug Administration, Brazil’s ANVISA, the Australian Therapeutic Goods Administration, the Japanese Pharmaceuticals and Medical Devices Agency and Health Canada.

MDSAP audits are intended to cover quality system requirements found in ISO 13485 and its derivatives, as well as Brazilian Good Manufacturing Practices (BGMP) and US Quality System Regulation 21 CFR Part 820.  

The MDSAP’s latest call for manufacturing participants suggests that the program’s coordinators are prepared to transition from pilot to full implementation, but the question of adequate buy-in form industry may still be a factor. According to a two-part Emergo report in May 2016, several challenges to MDSAP still flummoxed advocates just months ahead of the program’s launch.

Chief among the challenges identified by Emergo were major regulatory changes underway in the European medical device market, as well as low manufacturer participation rates in MDSAP due to cost-benefit skepticism among some companies and to slow rates of auditing organization accreditation by some regulators.

If successfully implemented, MDSAP has the potential to ease quality management system compliance efforts medical device companies currently face as they try to expand into various markets. Emergo will monitor the situation as the MDSAP pilot winds down and the full program takes shape in early 2017.  


  • Stewart Eisenhart