By Michael Dun and Stewart Eisenhart, Emergo
Since its inception and pilot-phase launch, the Medical Device Single Audit Program (MDSAP) has promised medical device companies the potential to tap into multiple markets without having to undergo multiple audits of their quality management systems (QMS).
With MDSAP’s multi-year pilot set for completion at the end of December, followed by full implementation early in 2017, manufacturers may question whether the program actually is ready for prime time. Ongoing gaps in coordination between some participating regulators — including the U.S. Food and Drug Administration (FDA), Health Canada, Brazil’s ANVISA, the Australian Therapeutic Goods Administration, and the Japanese Pharmaceutical and Medical Devices Agency (PMDA) — as well as low to middling participation rates so far among device manufacturers, may result in a less than auspicious launch.
Developed under the auspices of the International Medical Device Regulators Forum (IMDRF) to serve as a single global quality audit program, MDSAP is intended to alleviate the strains on regulators’ internal resources resultant of ensuring and enforcing quality compliance among medical device manufacturers. Furthermore, the program would streamline registration requirements and help reduce compliance costs for manufacturers by eliminating the need for multiple quality system audits and inspections.
MDSAP managers identified 13 auditing organizations (AOs) qualified to participate in the program pilot, and whose audits would be accepted by all five participating regulatory authorities.
Lukewarm Reception (So Far)
Despite what seems like a compelling value proposition for both regulators and manufacturers, MDSAP — at least in its pilot phase — has gained underwhelming traction so far.
Manufacturer buy-in represents the primary challenge to wider acceptance of MDSAP: As of August 2016, fewer than 3.9 percent of eligible manufacturers (129) had registered for participation in the program, and only 85 MDSAP audits had been performed. Although Health Canada announced that it would only accept MDSAP certifications from Canadian market registrants starting in 2019, in an effort to boost participation, it remains doubtful that this push will get the program closer to its target number of manufacturers by the end of 2016.
So, why such anemic MDSAP participation rates so far? One key factor is insufficient cost-benefit tradeoff. In Brazil, for example, ANVISA will continue assessing Brazilian Good Manufacturing Practice (BGMP) certification fees for MSDAP participants at the same rate as for registrants that do not participate in MDSAP. ANVISA also may charge additional processing fees to review MDSAP audit reports, further disincentivising MDSAP for potential participants. Additionally, as of IMDRF’s most recent meeting in September, not all auditing organizations eligible to participate in the program had been fully qualified.
ANVISA’s stance leads to another question: How effective will coordination be between participating regulatory bodies, in terms of policies and procedures for recognizing MDSAP audit reports? Unless regulators across all five MDSAP markets take the same or similar approaches to the program, the benefits to both themselves and to market registrants will be significantly diminished.
External factors also are challenging MDSAP’s effectiveness, both in its current pilot phase and in its future, following the program’s full launch.
A confluence of two major changes impacting the device industry — the release of a new ISO 13485 quality standard (ISO 13485:2016), and medical device/in vitro diagnostic regulatory overhauls in the massive European market — has complicated the MDSAP proposition.
As the European Medical Device Regulations (MDR) and In Vitro Diagnostic (IVD) Regulations come into effect, fewer manufacturers will be able to rely on self-declarations of conformity in order to obtain and maintain CE Mark certification. This is important because Notified Bodies — which include all 13 AOs in the MDSAP program — will face a major resource crunch in attempting to carry out new auditing activities. If these organizations will be struggling just to meet their obligations in Europe, how likely is it they also will be able to meet new MDSAP obligations? Until AOs that must also fulfill Notified Body roles adjust to both the new European regulations and ISO 13485:2016, they may make MDSAP less of a priority.
More Preparation And Resources Needed?
Although the challenges to more widespread participation in MDSAP are indeed considerable, they are not insurmountable. The IMDRF’s fundamental intentions for the program remain compelling, as QMS compliance can prove one of the most time-consuming and expensive aspects of medical device registration.
Still, more time may be necessary in order to address issues such as manufacturer participation, coordination among regulators, and a better idea of how two major changes for industry — ISO 13485:2016 and new European device and IVD regulations — will play out before the benefits of MDSAP can more fully come to fruition.
From the start of 2017, with the program moving out of its pilot phase, auditing organizations beyond the original 13 can participate in the MDSAP program. This should help to alleviate some of the stress being placed upon participating Notified Bodies. However, exactly how many of these organizations can meet the qualification requirements established by the IMDRF remains to be seen, given the rate of qualification during the pilot.
About The Authors
Michael Dun is Country Manager/Director of Emergo Australia and Stewart Eisenhart is Senior Regulatory Analyst at Emergo.