Spotlight on Australia: Life and Health Sciences

The Regulations NOTIFIED BODY EU MDR-Regulation (EU) 2017/745 IVDD Directive 98/79/EC IVDR- Regulation (EU) 2017/746: Applicable from 26 May 2017 with a 5-year transition period. FDA US Food, Drug and Cosmetic Act of 1938 The Code of Federal Regulations (CFR) Title 21 TGA Australia Therapeutic Goods Act 1989 Therapeutic Goods (Medical Devices) Regulations 2002 Australian Regulatory Guidelines for Medical Devices (ARGMD) MyMedical DEPARTMENT

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