Medical Device Single-Audit Pilot: Will it Fly?

Medical Device Single-Audit Pilot: Will it Fly?

Sandy Carson Hessen, Marketing Communications Manager, Pilgrim Quality Solutions

We’ve all seen them. Some flop, some fly. Television Pilots — stand-alone episodes of television series used to sell shows to the networks by gauging whether a series will be successful. After seeing this sample of the proposed program, networks then determine whether the expense of additional episodes is justified.

There’s another type of pilot airing right now in the Medical Device industry, and the purpose is similar.

In 2012, the International Medical Device Regulators Forum (IMDRF) identified a work group to develop specific documents for advancing a Medical Device Single Audit Program (MDSAP). The program would allow recognized third-party auditors to conduct a single audit of a device manufacturer that will be recognized internationally. Forum members agreed that this global approach to auditing and monitoring medical device manufacturing could improve product safety and oversight on an international scale. Sounds like a smash hit in the making, but one worth testing first.

The Cast of MDSAP

So this year, the FDA joined its counterparts from three other countries in launching a MDSAP pilot. The pilot is intended to allow MDSAP-recognized auditors to jointly leverage regulatory resources to manage an efficient, effective, and sustainable single-audit program. Joining the FDA in the pilot are:

  • Australia: Therapeutic Goods Administration (TGA) of Australia
  • Brazil: Agência Nacional de Vigilância Sanitária (ANVISA)
  • Canada: Health Canada

If the pilot is a success and the MDSAP program is implemented, 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.

What’s it About

Among the MSDAP’s stated objectives is “to promote greater alignment and flexible use of regulatory resources through work-sharing and mutual acceptance among regulators while respecting the sovereignty of each authority.”

For instance, ISO 13485:2003 is the core standard that is being used to “audit” medical device manufacturers, in addition to specific requirements identified by any country based on how they want to use the audit results. The USA is also including 21 CFR Part 820, which is their Quality System Regulation, and Brazil is requiring elements of RDC ANSVISA 16/2013 which is their Good Manufacturing Practices.

Another scenario: Previously, among the four countries, only Canada had a third-party auditor system in place in addition to its national authoritative body. Recognizing the increasingly global nature and number of medical device manufacturers worldwide, the other pilot countries have come aboard regarding the use of third-party auditors. Once a third party completes an audit, each jurisdiction can use those results. This way, individual governments’ auditing resources can instead be focused on high-risk or problematic medical devices, manufacturers that are not in compliance with the regulations, and oversight of the third-party auditing organizations.

Will MDSAP Get the Green Light?

MDSAP represents a significant milestone in global regulatory cooperation and recognition. If it gets the green light, it also will be welcome news for medical device manufacturers as it will save thousands of dollars in registrar fees, eliminate unnecessary duplication of inspections, and allow faster access to markets in US, Canada, Brazil, and Australia.

According to the FDA, the MDSAP pilot is currently on schedule. When the pilot concludes, estimated for the end of 2016, additional auditing organizations may be eligible for the application in the MDSAP to further help drive future global regulatory harmonization. Let’s wait to hear what the critics say.

Please stay tuned to the Pilgrim blog for more on MDSAP and other related topics.


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Sandy Carson

Marketing Communications & Events Manager, Pilgrim Quality Solutions

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