Arthur Brandwood

Sauce

China update – regulation with a European sauce?

CFDA continues to propose more changes to medical device regulation, and as ever the agency looks to international practices and seeks to weave them in to China requirements. A recent...
Ventilator patient

Biocompatibility of Breathing Gas Pathways

ISO 10993-1 requires that devices which contact the body indirectly - by means of a fluid or gas passed through the device and into the patient - must be assessed...
TGA introduces new Class Device application Fee, plus general 1.9 percent increase. Brandwood Biomedical Global Medical Device and IVD Regulatory Services

TGA introduces new Class I Device application Fee, plus general 1.9% increase.

In a long-anticipated change, TGA today announced the introduction of a new $530 application fee for Class I medical devices and an overall increase of 1.9% to most other TGA...

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