Medical devices functionality assessment

Therapeutic Devices Evaluation Committee (TDEC). TDEC is a statutory committee established under the Regulations to the Therapeutic Goods Act, 1989. Its functions are to advise on registration of medical devices. This committee advises on policies cmd priorities rather than the registration of individual devices. Individual device registration is hcmdled within the Medical Devices Section of the Conformity Assessment Branch (CAB) of the TGA. However, unusual or controversial matters are referred to the TDEC. The membership of TDEC reflects the wide range and diversity of therapeutic devices. The committee establishes subcommittees and advisory panels to address particular matters of interest. 

Ure second perspective regarding the in vivo assessment of medical devices focuses on the biocompatibility of the final product, that is, the medical device and its component materials in the condition in which it is implanted. While medical devices in their firral form and condition are commonly implanted in carefully selected animal models to determine function as well as biocompatibility, it may not be appropriate to carry out all of the recommended tests necessary for regulatory approval on the final device. In these situations, some tests maybe carried out on biomaterial components of devices that have been prepared under manufacturing and sterilization conditions and other processes utilized in the final product development. 

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