The Therapeutic Goods Act 1989 regulates the supply of therapeutic goods in Australia. Unless exempt or excluded, therapeutic goods may not be supplied to the Australian market unless they are listed or registered in the Australia Register of Therapeutic Goods (ARTG).

The requirements for listing or registering a therapeutic device under the Act are set out in Australian Medical Device Requirements - Version 4 (DR4). Electrical safety is a primary requirement .

The safety of electromedical equipment used in hospitals, clinics or at home should never be in question. Equipment available in Australia comes from many different countries with no common systems of certification or levels of quality. The purchaser is asked to take much on faith and on documentation that is complicated and difficult to understand.

The situation is such that even state government health authorities are now finding it necessary to request statements of full compliance to Australian Standards for equipment tenders.

TCA’s Certificate of Conformance ensures that the product you purchase satisfies the TGA safety requirements for electromedical equipment.

Testing & Certification Australia Product Compliance

14 Nelson Street Chatswood NSW 2067 Australia Ph: +612 9410 5111 Fax: +612 9415 1567