TGA (Australia)
Therapeutic Goods Administration
Australia's regulator for therapeutic goods — medicines, medical devices, biologicals, blood and tissues — operating under the Therapeutic Goods Act 1989.
TGA assesses, registers and monitors therapeutic goods on the Australian Register of Therapeutic Goods (ARTG). For medicines, PIC/S GMP Guide PE 009 is adopted; for devices, the Medical Devices Regulations 2002 with classification rules aligned to GHTF/IMDRF and EU MDR. TGA is a founding MDSAP regulator and accepts MDSAP audits in lieu of inspections.
For pharma the Manufacturing Principles incorporate the PIC/S GMP Guide. For devices a Conformity Assessment Certificate (or recognised overseas CAB approval, including TGA-recognised EU NB certificates) is required for Class IIa and above.
- Therapeutic Goods Act 1989 (Cth)
- Therapeutic Goods (Medical Devices) Regulations 2002
- PIC/S GMP Guide PE 009
Free trial, no credit card, onboard in days, not months.