On November 23, the Therapeutic Good Administration (TGA) published the revision of the Clinical Evidence Guidelines Version 3.2, in which the clinical evidence requirements for Medical Devices and IVDs are set out.

The guideline aims at being a common point of reference for both industry and the Regulatory Authority, helping Sponsors and Manufacturers to collect, complete and submit clinical evidence to meet Australian requirements, introducing new chapters on ophthalmic devices and Medical Devices incorporating a medicinal substance and modifications to breast implants and tissue expanders. References to data and evidence have also been added.

Concerning ophthalmic devices, the reference section provides guidance on the nature and type of clinical evidence generally expected to demonstrate compliance with the relevant provisions of the Essential Principles.

The section on substance-based Medical Devices provides guidance on expectations about devices incorporating, as an integral part, substances that, if used separately, would constitute medicinal products and are likely to act on the patient’s body with action ancillary to that of the device.

As regards breast implants and tissue expanders, the guideline covers breast implants filled with saline, silicone gel or alternative fillers intended for breast augmentation or 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.

The revision of the guideline by the TGA aims at updating the Australian regulatory framework to keep pace with other world countries such as the USA and China by regulating devices such as substance-based devices that are increasingly used.

>> Through strategic-regulatory consulting Thema supports the registration with Therapeutic Good Administration for the marketing of Medical Devices and IVDs in Australia.


Clinical Evidence Guidelines Version 3.2