Australian Therapeutic Goods Medical Devices Regulations

Therapeutic Goods (Medical Devices) Regulations 2002

https://www.legislation.gov.au/Details/F2017C00534

This is a compilation of the Therapeutic Goods (Medical Devices) Regulations 2002 that shows the text of the law as amended and in force on 1 July 2017 (the compilation date). The notes at the end of this compilation (the endnotes) …

Australian regulatory guidelines for medical devices …

https://www.tga.gov.au/resources/resource/guidance/australian-regulatory-guidelines-medical-devices-argmd

Medical device (including IVD devices) inclusion process; On 23 July 2021 the Government repealed Regulation 4.1 and amended Regulation 5.3 of the Therapeutic …

Therapeutic Goods (Medical Devices) Regulations 2002

https://www.legislation.gov.au/Details/F2020C00112

Therapeutic Goods (Medical Devices) Regulations 2002 - F2020C00112 In force- Superseded Version View Series SR 2002 No. 236Regulations as amended, …

Therapeutic Goods (Medical Devices) Regulations 2002

https://www.legislation.gov.au/Details/F2022C00061

This is a compilation of the Therapeutic Goods (Medical Devices) Regulations 2002 that shows the text of the law as amended and in force on 18 …

Medical devices regulation basics - Therapeutic Goods …

https://www.tga.gov.au/medical-devices-regulation-basics

Therapeutic Goods (Medical Devices) Regulations 2002

https://www.legislation.gov.au/Details/F2023C00032

Class IIb medical devices (other than medical devices used for a special purpose) 8 3.7A...................... Class 3 IVD medical devices (other than devices to be …

Regulation basics | Therapeutic Goods Administration …

https://www.tga.gov.au/regulation-basics

The labelling and packaging of therapeutic goods is regulated by the TGA Ingredients in therapeutic goods Medicines and other therapeutic goods are usually made from a …

Australian declaration of conformity templates (medical …

https://www.tga.gov.au/how-we-regulate/manufacturing/manufacture-medical-device/obtain-and-maintain-regulatory-evidence/tga-conformity-assessment/australian-declaration-conformity-templates-medical-devices

Declaration made in accordance with the requirements of Clause 6.6 of Schedule 3 of the Australian Therapeutic Goods (Medical Devices) Regulations 2002. Further …

Australian regulatory guidelines for medical devices …

https://www.tga.gov.au/resources/publication/publications/australian-regulatory-guidelines-medical-devices-argmd-v11-archived-version

The Australian Medical Device Requirements Under the Therapeutic Goods Act 1989 (version 4), or DR4, available on the TGA website, provides guidance for these products. …

Therapeutic Goods (Medical Devices) Regulations 2002

https://www.legislation.gov.au/Details/F2012C00424

(1) For paragraph 41EA (a) of the Act and subject to subregulation (3), the kind of manufacturer in respect of whom a conformity assessment certificate must be issued …