- The Australian regulator has received broad industry support for its plans to create a unique device identification (UDI) system for medical devices, the agency said Wednesday.
- Local and foreign medical device trade groups and manufacturers backed the plan to base the UDI system on international guidance and implement it over a several years, starting with its application to Class III and implantable products.
- However, companies including the medtech units of Johnson & Johnson and Roche, pushed back against aspects of the proposal, including the planned adoption of an identifier used in Europe.
When Australia's Therapeutic Goods Administration ran the UDI consultation at the start of the year, it sought to gather views on the merits of introducing a system it thinks it will improve outcomes, including patient safety.
The response to the consultation suggests the creation of a UDI system will go ahead. TGA found a "strong consensus across all stakeholder groups for the need to introduce the UDI system," leading it to move forward with the development of legislation that will facilitate the work.
In general, the respondents welcomed TGA's plans to base the system on guidelines in development at the International Medical Device Regulators Forum and align it with standards already in use in the U.S. and Europe. However, TGA's following of its international peers also created perceived problems, ranging from confusion to the proposed adoption of flawed or unnecessary policies and features.
"Unfortunately, it is not always clear in the proposal what elements TGA is proposing for the Australia UDI system and what elements simply reflect the current state in other jurisdictions," J&J wrote.
J&J singled out the list of UDI database elements as an example of the problem. Noting that TGA looks to have copied European Union requirements, J&J picked out proposed data elements that are irrelevant in the Australian context, such as EU authorized representatives.
Other respondents picked up on further shortcomings created by TGA's decision to look to the EU for inspiration. Trade group MedTech Europe and Roche, one of its members, spoke out strongly against the proposed use of Basic UDI-DI, the key device identifier in the European database on medical devices.
"We urge TGA to eliminate the concept of Basic UDI-DI from UDI requirements," Roche wrote. "Adding Basic UDI-DI to AusUDID would add complexity to the implementation of UDI in Australia without serving the function of public health and safety."
The pushback reflects the belief that Basic UDI-DI is only used in the EU because the region lacks a common approval numbering system and has a database that hosts pre- and post-approval data. As Australia has an existing numbering system and is limiting its database to UDI data, sections of the device industry said adopting Basic UDI-DI will lead to unnecessary problems.
TGA is using the responses to inform its next steps. Work is underway to develop legislation to support the creation of an Australian UDI system.