Australia – Expands Range of Acceptable Foreign Regulators for Device Applications

Beginning this month, Australia’s Therapeutic Goods Administration (TGA) will expand its range of acceptable international assessments and approvals on medical device applications.

TGA said Monday the number of comparable overseas regulators (COR) will start to include not just EU notified bodies, but also the US Food and Drug Administration (FDA), Health Canada, auditing organizations under the Medical Device Single Audit Program, as well as Japan’s Ministry of Health, Labour and Welfare and its Pharmaceutical and Medical Devices Agency.

The decision comes as TGA’s response to a previous recommendation from the Australian government, which was based on its review of the medicines and medical devices regulation, for the regulator to enhance its use of certain marketing approvals for devices in foreign markets…