Medical devices & therapeutic goods compliance in Queensland
Federal + Qld-specific compliance obligations for medical devices & therapeutic goods businesses operating in Queensland.
4
Total obligations
0
Qld-specific
18
Qld regulators
Federal obligations also applicable
In-vitro diagnostic medical device classification + ARTG
IVDs classified by risk (Class 1-4); ARTG inclusion required for supply.
Conduct post-market surveillance of therapeutic goods
ARTG-included goods must be monitored post-market for safety + performance.
Notify ACCC of a voluntary recall within 2 days
Suppliers must notify the ACCC within 2 days of initiating a voluntary consumer product recall.
Comply with the Therapeutic Goods Advertising Code
Advertising of therapeutic goods to consumers must comply with the TGA Advertising Code and prohibited representations.
Applicability answers for medical devices & therapeutic goods
Need the federal-only picture?
See national medical devices & therapeutic goods compliance for the full federal picture.