Update: Australian Clinical Evidence Guidelines for Medical Devices
In November 2023 Australia’s regulatory board, Therapeutic Goods Administration (TGA) released a revision of the Clinical Evidence Guideline Version 3.2. This revision sets out new guidelines on the clinical evidence required for medical device including IVDs under Australian legislation.
These guidelines aid from an industrial and regulatory reference for sponsors and manufactures when completing a clinical evidence report. New chapters have been introduced which are on ophthalmic devices, medical devices incorporating a medicinal substance and modifications to breast implants and tissue expanders.
Let’s get into it; considering ophthalmic devices, the guidance provides details on the nature and type of clinical evidence generally expected to demonstrate compliance with the relevant provisions of the Essential Principles. In regard to, substance-based medical devices the guidance elaborates on expectations about devices incorporating, as an integral part. How substances that, if used separately, could constitute to medicinal products and likely to act on the patient’s body with action ancillary to that of the device.
Lastly, breast implants and tissue expanders, the guideline covers breast implants filled with saline, silicone gel or alternative fillers intended for breast augmentation/reconstruction and considers tissue expanders used in breast reconstruction.
The reference section on data and evidence gives summary recommendations, definitions, and necessary evidence concerning clinical investigations. Concerning data and evidence, clinical data can be generated either for the device itself or for a comparable device and include data from clinical investigations, literature review, post-market data and other clinical experience data.
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