Therapeutic Goods (Medical Devices) Regulations 2002 (iii) the new device is an IVD medical device and its early availability in Australia will result in a . Therapeutic Goods (Medical Devices) Regulations 2002 that all of the following criteria are satisfied in relation to the medical device (the new device):. 4 thg 4, 2019 - The current regulatory framework for in vitro diagnostic medical devices (IVDs) was introduced in 2010 via amendments to the Therapeutic Goods (Medical Devices) Regulations 2002 and the Therapeutic Goods Regulations 1990. . An extension has now been made through amendments to those regulations. All medical devices marketed in Australia must meet the requirements which are set out in Chapter 4 of the Therapeutic Goods Act 1989, and in the Therapeutic Goods (Medical Devices) Regulations 2002. . New guidance available. Authorizing legislation: Therapeutic Goods Act 1989 (as amended) . Therapeutic Goods Regulations 1990 Therapeutic Goods (Medical Devices) Regulations. 18 thg 4, 2019 - The TGA is a division of the Department of Health and is responsible for . Goods (Medical Device) Regulations 2002; and Therapeutic Goods . It also ensures access to new therapeutic goods for the population and protects public . In matters of medical device safety, quality, and performance, the TGA is advised by the . A list of TGA regulations can be found here on our website. The Expert Panel Review of Medicines and Medical Device Regulation (the . to transition more quickly to the new requirements as these products have been . 18 thg 5, 2018 - New therapeutic goods legislation also came into effect earlier this year. . the Therapeutic Goods (Medical Devices) Regulations 2002, as well . 29 thg 3, 2019 - The Therapeutic Goods Administration (TGA) is consulting on proposed new regulations for a wide range of medical devices to make Australia .