Australia Releases Costs, Details of Planned Premarket Reforms

Australia’s Therapeutic Goods Administration is recommending to move forward with a proposal that would increase the number of mandatory audits for high-risk devices, make transparent all device regulatory decisions and allow all but Class IV in vitro diagnostic devicemakers to use non-TGA conformity assessments.

The endorsement follows a public consultation and regulatory analysis of three options aimed at strengthening the country’s premarket evaluation of medical devices. The other two options were to maintain the status quo or to expand TGA mandatory conformity assessments for active implantable medical devices and Class III implantable devices and permit third-party assessments of other devices except Class IV IVDs.

The three options, released in January, stem from a 2010 discussion paper and two subsequent Senate investigations that led the government to focus on the safety of higher-risk devices, such as metal-on-metal hip implants. The premarket assessment reforms being considered — Option 2 — would help to ensure speedy access to new devices through continued use of European certification while current concerns about possible safety risks are addressed, the regulatory impact statement (RIS) says.

These reforms address all of TGA’s concerns and have “overwhelming support from stakeholders,” the agency said. Since being introduced in January, the plan to abolish the TGA conformity assessment requirement was expanded from lower-risk products only to all devices made by Australian manufacturers, a move widely applauded by industry.

However, industry remains cool to the concept of Level 3 audits for high-risk devices, largely due to the increased cost and assessment time, the RIS states.

According to the impact analysis, the estimated annual costs to industry of the increased audits, in U.S. dollars, would be $690,969 for Class IIb implanted devices and $4.3 million for Class III implants. The TGA estimates that publishing regulatory decisions would cost another $1.6 million. But Australian devicemakers also stand to save $1.04 million due to the abolition of TGA-only conformity assessments.

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