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Australian Medical devices regulation basics
Here below are reported some of the most relevant guidance for Medical Device Registration in Australian market:
Major Regulations
Regulation | Year |
Therapeutic Goods MD Regulation | 2002 |
Therapeutic Goods Regulations | 1990 |
Therapeutic Goods Act | 1989 |
General Guidance Documents
Document | Year |
Australian Regulatory Guidelines for Medical Devices (ARGMD) | 2011 |
IVD Guidance Documents
Forms and Applications
Additional Information
Document | Year |
Schedule of fees and charges | 2019 |
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