EMERGO SUMMARY OF KEY POINTS:

• The Medical Device Single Audit Program (MDSAP) ended its pilot phase and became fully implemented in January 2017 in the United States, Canada, Brazil, Australia and Japan.
• In Australia, only larger medical device manufacturers have shown interest in MDSAP so far.
• Smaller Australian manufacturers have yet to be sold on MDSAP’s benefits.

Now that the Medical Device Single Audit Program has moved past its pilot phase in participating medical device markets, how are manufacturers and regulators warming to the program?

Over a series of blog posts, we’ll examine how the fully fledged MDSAP is being received in the five markets participating in the program: the United States, Canada, Brazil, Australia and Japan.

Australia: Reservations, skepticism among industry participants

In Australia, the Therapeutic Goods Administration (TGA) most recently commented on MDSAP in December 2016, when the regulator announced the conclusion of the program’s pilot phase and listed eligibility requirements for auditing organizations.

According to Michael Dun, Country Manager and Director at Emergo’s Sydney office, Australian manufacturers have expressed some interest in MDSAP; however, Dun reports three key reasons for reluctance to participate:

• First, manufacturers have yet to be convinced of a cost benefit to be gained from participating in MDSAP.
• Second, some firms are wary of “appearing on the radar” of regulatory agencies before they’ve established a presence in a particular market, or before their facilities have yet undergone inspections.
• Third, some Australian firms show little interest in expanding into other markets participating in the program.

Furthermore, although the TGA has made efforts to promote MDSAP participation among Australian manufacturers, so far only larger organizations with the budgets and business plans to operate in other markets where MDSAP audits are accepted have signed up for the program, Dun says.

How will TGA handle MDSAP audit reports?

Australian regulators have stated three instances in which they will take MDSAP audit reports into account when determining quality system compliance:

• Deciding whether to issue or renew conformity assessment certificates for combination products
• Reviewing applications for device entry into the Australian Register of Therapeutic Goods (ARTG) database in instances where evidence of quality system compliance is required (ISO 13485 quality system compliance is required in Australia)
• When CE Marking conformity assessment certification for a market applicant’s quality system is not available

Based on the program’s reception so far in Australia, MDSAP advocates have some work to do still to convince more manufacturers of the benefits of signing up. We will provide further analysis of MDSAP implementation and adoption rates in other markets over the coming weeks.

For more information on Australia’s medical device registration system, watch our video overview and read our whitepaper.