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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 Doubts?
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Doubts ?
Reach out to us and we will help you clarify your situation