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Therapeutic Goods Act 1989 - Legislation
- https://www.legislation.gov.au/Details/C2017C00226
- This is a compilation of the Therapeutic Goods Act 1989 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) include information about amending laws and the …
Australian Medical Device Requirements Version 4 …
- https://www.tga.gov.au/sites/default/files/dr4-toc.pdf
- Aboutthe Therapeutic Goods Administration (TGA) is a division of the Australian Government Department of Health and Ageing, and is responsibleTGA administers for …
Australian Medical Device Requirements Version 4 …
- https://www.tga.gov.au/sites/default/files/dr4-v1-s1.pdf
- The Conformity Assessment Branch (CAB) is responsible for the regulation of therapeutic devices under the Act. The types of therapeutic devices which are required …
THERAPEUTIC GOODS ACT 1989 - SECT 41BD What …
- http://www5.austlii.edu.au/au/legis/cth/consol_act/tga1989191/s41bd.html
- THERAPEUTIC GOODS ACT 1989 - SECT 41BD What is a medical device (1) A medical device is: (a) any instrument, apparatus, appliance, software, implant, reagent, …
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. …
Australian Medical Device Requirements Version 4 …
- https://www.tga.gov.au/sites/default/files/dr4-v1-s3.pdf
- and medical devices. • The TGA relies on the public, healthcare professionals and industry to report problems with medicines or medical devices. TGA investigates reports received …
Manufacturing therapeutic goods - Therapeutic Goods …
- https://www.tga.gov.au/manufacturing-therapeutic-goods
- In Australia, the Therapeutic Goods Act 1989 requires, with certain exceptions, that manufacturers of therapeutic goods hold a licence or a conformity assessment …
THERAPEUTIC GOODS ACT 1989 - SECT 41BE Kinds …
- http://classic.austlii.edu.au/au/legis/cth/consol_act/tga1989191/s41be.html
- THERAPEUTIC GOODS ACT 1989 - SECT 41BE Kinds of medical devices General (1) For the purposes of this Chapter, a medical device is taken to be of the same kind as …
THERAPEUTIC GOODS ACT 1989 - SECT 41FN …
- http://www5.austlii.edu.au/au/legis/cth/consol_act/tga1989191/s41fn.html
- THERAPEUTIC GOODS ACT 1989 - SECT 41FNConditions applying automatically. Commonwealth Consolidated Acts. [Index][Table][Search][Search this …
Therapeutic Goods (Medical Devices) Regulations 2002
- https://www.legislation.gov.au/Details/F2017C00534
- 12.2 Safety dependent on internal power supply. (1) This clause applies in relation to a medical device if the safety of a patient on whom the device is to be used will …
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