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.
As part of the decision, TGA released new guidance on Monday to aid industry in bridging the gap between previously obtained overseas assessments and approvals and the inclusion of medical devices in the Australian Register of Therapeutic Goods (ARTG) as applicable.
The guidance document sets forth the requirements for TGA to take into consideration overseas documentation, including on FDA decisions and Health Canada approvals and licenses, as evidence for its own assessments. For example, the proposed documentation should be on the same device and design for the same intended purpose and indications.
“This will result in the TGA being able to reduce the amount of assessment that it must undertake on a particular application,” the regulator said.
The regulator implemented a new COR process for work-sharing on drug applications in June.
A separate notice posted by TGA on Monday provides additional guidance on applications requirements for medical devices to pass preliminary assessments for inclusion in the ARTG.
Comparable overseas regulators for medical device applications
Application requirements for medical devices - preliminary assessment