Australia TGA Medical Device Regulations

Log into RAMS to download the documents listed below along with more regulations and guidances for Australia.

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Major Regulations
Document Number Published Language
Log in Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019 2019 English
Log in Therapeutic Goods (Medical Devices) Regulations 2002 2002 English
Log in Therapeutic Goods Regulations 1990 1990 English
Log in Therapeutic Goods Act 1989 1989 English
General Guidance Documents
Document Number Published Language
Log in Australian Regulatory Guidelines for Medical Devices (ARGMD) English
Log in Therapeutic Goods (Medical Devices-Information that Must Accompany Application for Inclusion) Determination 2018 2018 English
Specific Guidance Documents
Document Number Published Language
Log in Clinical Evidence Guidelines Supplement - In Vitro Diagnostic (IVD) Medical Devices 1.0 2020 English
Log in Guidance for Declaration of Conformity for Class I Non-sterile Non-measuring and Class 1 In Vitro Diagnostic (IVD) Medical Devices 1.0 2020 English
Log in Uniform Recall Procedure for Therapeutic Goods (URPTG) 2.2 2019 English