Compliance for Medical devices & therapeutic goods
Suppliers of therapeutic goods listed on the ARTG.
Published obligations that apply to medical devices & therapeutic goods (4)
- criticalCWLTHIn-vitro diagnostic medical device classification + ARTG
IVDs classified by risk (Class 1-4); ARTG inclusion required for supply.
- criticalCWLTHConduct post-market surveillance of therapeutic goods
ARTG-included goods must be monitored post-market for safety + performance.
- highCWLTHNotify ACCC of a voluntary recall within 2 days
Suppliers must notify the ACCC within 2 days of initiating a voluntary consumer product recall.
- highCWLTHComply with the Therapeutic Goods Advertising Code
Advertising of therapeutic goods to consumers must comply with the TGA Advertising Code and prohibited representations.