Medical devices & therapeutic goods compliance in New South Wales
Federal + NSW-specific compliance obligations for medical devices & therapeutic goods businesses operating in New South Wales.
4
Total obligations
0
NSW-specific
20
NSW regulators
Federal obligations also applicable
Conduct post-market surveillance of therapeutic goods
ARTG-included goods must be monitored post-market for safety + performance.
In-vitro diagnostic medical device classification + ARTG
IVDs classified by risk (Class 1-4); ARTG inclusion required for supply.
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.
Need the federal-only picture?
See national medical devices & therapeutic goods compliance for the full federal picture.