The Therapeutic Goods Administration (TGA), Australia’s medical device market regulatory entity, has issued several updates regarding Unique Device Identification (UDI) regulations, Essential Principles compliance requirements and guidelines for active medical devices.
UDI implementation updates
First, the TGA has published a new consultation paper seeking stakeholder feedback on the regulator’s proposed UDI framework. TGA proposals include:
- Accepting device labels already compliant with US as well as European Union requirements;
- Phased UDI implementation approaches according to device risk classifications;
- Regulatory scope and exemptions;
- Data provisions and maintenance;
- Labeling and documentation requirements;
- Adoption and application in healthcare system settings…
