The Australian Government has recently implemented some major changes to the Therapeutic Goods Act 1989 (the Act) and the Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations). Starting 25th August 2020, TGA has adopted new medical device definition and a number of other related definitions in the Therapeutic Goods Act 1989 (the Act) and the Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations), as well as minor amendments to the requirements for system or procedure packs in the Regulations.
Essentially, the Therapeutic Goods Act 1989 (the Act) serves as the mother law that governs quality, safety, timely availability and, where necessary, efficacy, of therapeutic goods that are used in Australia. According to the new changes implemented. Definitions for medical device, accessory and system or procedure packs in the Act have been amended to reflect the new definitions in the Therapeutic Goods Amendment (2020 Measures No. 1) Act 2020.
The amended definitions for medical device and accessory provide additional clarification around certain aspects of "what is a medical device" or "an accessory to a medical device" that were already considered within the scope of the existing definition, but not explicitly stated in legislation. These clarifications include software, implants and reagents, and goods used for the in vitro examination of a specimen collected from the human body for medical purposes. These amendments also support harmonization activities by aligning more closely with the equivalent definitions in the European Union.
The new definition of system or procedure packs clarifies a number of aspects of the current definition and is designed to more closely align these terms with the system and procedure pack definitions in Regulation (EU) 2017/745 of the European Parliament and the Council of 5 April 2017 on medical devices (the EU Regulations) - combining the scope of both these definitions in the updated definition of system or procedure packs.