EMERGO SUMMARY OF KEY POINTS:

• The Australian TGA is developing a market access pathway whereby medical devices approved by certain overseas regulators would gain Australian market access without undergoing additional conformity assessments.
• The TGA has not yet determined which overseas regulatory approvals would be included in the new program.
• Amendments to existing laws concerning Australian medical device regulation will be introduced throughout 2017 to facilitate implementation of the new pathway.

Australia’s Therapeutic Goods Administration (TGA) has proposed allowing commercialization of medical devices that have already obtained approval from regulators in other markets without undergoing full premarket review.

Such a development would allow device manufacturers that have gained regulatory approval in markets such as the US, Europe or Japan to also be listed in the Australian Register of Therapeutic Goods (ARTG) while foregoing TGA premarket review, provided certain conditions are met. Specifically, Australian market registrants would have to show that their conformity assessments from overseas regulators also demonstrate compliance with TGA regulatory requirements for safety, quality and performance in order for inclusion in the ARTG without the need for a full Australian premarket conformity assessment.

The TGA has not yet indicated which overseas regulatory approvals would be included in its proposed new registration pathway, but fellow regulatory members of the International Medical Device Regulators Forum (IMDRF)—the US, Europe, Japan, Brazil, Canada, China, Russia and Singapore—will likely be considered, according to the TGA’s consultation.

Possible criteria for inclusion in the TGA program

The TGA is seeking industry input on how to identify foreign device regulators with market authorization requirements similar to those of the Australian agency, as well as on which foreign authorities are most similar to the TGA in terms of how they designate third parties.

The regulator has proposed five major criteria for determining whether a particular overseas regulator’s approval process is comparable enough to Australia’s that devices approved by that regulator may forego premarket review by the TGA:

• How comparable is the overseas regulator’s framework to that of the TGA?
• Is the regulator an IMDRF member?
• Does the regulator’s framework cover the whole lifecycle of the device, and does the regulator take a robust approach to post-market vigilance?
• Does the regulator maintain adequate communication and cooperation efforts with regulators of other markets?
• How experienced is the regulator in device evaluations, quality system inspections or audits and related functions that accord with international standards and best practices?

Steps to implementation

According to the TGA consultation, implementation of such a pathway would first require amending the Therapeutic Goods Act 1989 by legislators. The regulator anticipates that specific regulatory amendments will be developed and published over the course of 2017, followed by commencement in early 2018.

Implications for industry

Michael Dun, Country Manager and Director At Emergo Australia, notes that currently the most common route to market entry in the country for many foreign device manufacturers is by leveraging their CE Mark.

"The proposed consultation, if adopted by the TGA, would mean that many foreign device manufacturers looking to enter the Australian market may have more options to leverage marketing authorizations or approvals in other countries rather than just CE Marking," Dun explains. "By providing more options to foreign manufacturers, the expectation is that this would also subsequently result in a lower burden upon TGA reviewers and reduce processing time for ARTG entry applications, meaning a faster pathway to market without compromising public safety."

The TGA is accepting public feedback on the proposed changaes until June 30, 2017. Emergo consultants in Sydney will continue monitoring these developments and provide updates over the course of 2017.

Additional resources for the Australian medical device market:

• Australian TGA registration support for medical device companies
• TGA Sponsor in-country representation for foreign medical device companies
• Australian medical device regulatory process chart
• Whitepaper: Medical device registration in Australia and New Zealand