TGA Reviews Comments on Unique Device Identification System
Australia’s Therapeutic Goods Administration (TGA) said public comments on its proposal to set up a unique device identification (UDI) system for medical devices show “a strong consensus” in favor of the idea.
The majority of submissions called for linking the UDI database with the agency’s Register of Therapeutic Goods (ARTG). Most comments urged the agency to use the International Medical Device Regulators Forum’s UDI guidance as a basis for the system, including its labeling requirements.
Some respondents proposed the exemption of low-risk devices — Class I non-sterile with no measuring function — from the UDI requirements, suggesting that there is minimal safety benefit in including them in the system, the agency said.