Australian Government Accepts Proposals for Multiple Market Pathways for Medical Devices

EMERGO SUMMARY OF KEY POINTS:

  • The Australian Department of Health has accepted expert panel recommendations to establish multiple market pathways for medical device registrants.
  • Expedited approvals and Therapeutic Goods Administration recognition of market authorizations from foreign regulators are included in the recommendations.
  • The Australian government plans to begin implementing regulatory reforms in 2016 and 2017.

Australia TGA medical device regulatory reforms 2016Responding to a series of new medical device and pharmaceutical regulatory reform proposals, the Australian government has expressed support for more than one pathway to market authorization in order to boost patient and user access to new devices.

The proposals follow an assessment of Australia’s current drug and medical device regulatory system starting in late 2014 by a government-commissioned expert panel. The Australian Department of Health officially responded to 58 panel recommendations.

Among recommendations for improving the Therapeutic Goods Administration (TGA) oversight of medical devices, the panel proposed establishing three major market pathways for manufacturers to commercialize their products in Australia:

  • First, Australian market registrants would undergo conformity assessments in the country either by the TGA or another entity designated by the TGA to perform such assessments.
  • Second, registrants could use marketing approvals obtained in other markets to satisfy TGA requirements, provided that those registrants have either undergone conformity assessments by regulator-accredited organizations in those other markets or obtained their approvals directly from a market regulator.
  • Third, devices may obtain expedited TGA approval under certain circumstances.

The government has officially accepted these recommendations, stating that implementing multiple market pathways would “streamline access to medical devices for consumers, provide additional flexibility for sponsors, and is consistent with the Government’s regulatory reform and contestability agendas.”

The Department of Health plans to implement “early opportunities” of the expert panel’s recommendations in 2016 and 2017, according to its official response. 

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