Australia Regulatory Framework Medical Device registration
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
Document | Year |
| Australian Regulatory Guidelines for Medical Devices (ARGMD) | 2011 |
IVD Guidance
Forms and Applications
Regulation | Year |
| Therapeutic Goods MD Regulation | 2002 |
| Therapeutic Goods Regulations | 1990 |
| Therapeutic Goods Act | 1989 |
Document | Year |
| Australian Regulatory Guidelines for Medical Devices (ARGMD) | 2011 |
