Resources
All regulatory process charts are available to download in Regulatory Affairs Management Suite (RAMS). Get your first chart for free when you create a RAMS account.
Get smart about Australia in 1 hour
If you are thinking about entering the Australian market for the first time, understanding the Therapeutic Goods Association (TGA) regulatory
Medical Device Registration in Australia & New Zealand
Thinking about selling your medical device or IVD in Australia or New Zealand? If your device already has CE Marking or approvals in other key
TGA - Australia Therapeutic Goods Administration
The Therapeutic Goods Administration is the Australian regulatory authority for therapeutic goods such as pharmaceuticals, blood products and tissues
AUSTRALIA – Overview of medical device industry and healthcare stats
Below you will find basic demographic and healthcare market data on Australia, plus specific information about the medical device and healthcare
Australia TGA Medical Device Regulations
Log into RAMS to download the documents listed below along with more regulations and guidances for Australia. LOG INTO RAMS Related services for
Bangladesh medical device & IVD approval process
Related services: Certificate of Free Sale (CFS) for Medical Device Exports Certificate to Foreign Government (CFG) for medical devices Clinical
Medical device registration process in Brazil
Interested in selling your medical device in Brazil? Brazil's device registration process is well established, but rather complex. It's important to