From: www.raps.org - Regulatory in Focus by Ana Mulero
Device companies were given a tight deadline on Monday to comment on a new proposal that would establish a unique device identification (UDI) system in Australia.
Australia’s Therapeutic Goods Administration (TGA) set forth the 19-page proposal in response to a growing demand to improve how medical devices are tracked throughout the supply chain, with a deadline for industry to respond by 18 February. TGA said that it is “exploring the feasibility of introducing the UDI system in Australia, including options for development of the UDI database.”
TGA called for input on implementation of a globally harmonized UDI system in Australia. Sponsors of most medical devices supplied in Australia would be required to include unique device identifiers and submit data to the Australian UDI database under the proposed system. Amendments for designated agencies to have the authority to issue unique device identifiers is one of the proposed first actions.
The move comes after several other countries in the International Medical Device Regulators Forum (IMDRF) already embarked on transitions to nationwide UDI adoption in recent years. These include the US, Europe, China, Canada and Brazil, among others. Adoption of TGA’s proposed system would result in slightly different UDI adoption across eight out of the current ten IMDRF member countries, with the transitions proving to be more complicated than previously anticipated over a range of technical issues.
“There is now worldwide recognition that, in the interests of patient safety and improved industry outcomes, the ability to unambiguously identify medical devices is essential,” TGA noted. The UDI system’s development and implementation is “widely acknowledged by the industry and regulators as an effective mean of ensuring timely access to complete, accurate and consistent information about medical devices.”’ Other intended benefits relate to supply chain disruption and device interventions.
TGA’s move also follows on the heels of several documents about UDI systems that IMDRF proposed last year as supplements to final UDI guidancefrom 2013. These include two information documents on the use of UDI data elements across IMDRF jurisdictions and recording unique device identifiers in electronic health records, as well as one guidance document for the harmonized development of UDI systems.
“Although we intend to harmonize with international UDI systems, it is important to note that legislative and regulatory frameworks are structured differently and there is variation in the legal terminology acceptable in each jurisdiction,” TGA said. Its proposal leans on IMDRF, the US and the EU. “We note some instances of divergence and these mostly relate to definitions that are specific to the EU Regulations. Publication of IMDRF’s UDI application guide in 2019 will further inform this work.”
In contrast with other UDI systems, TGA is proposing to exempt certain devices from its UDI requirements, including custom-made devices and those that are not regulated as medical devices in other jurisdictions. “While it is highly desirable to align internationally, we seek stakeholders’ feedback on proposals for possible exemptions from UDI requirements,” the regulator said. TGA is also posing the question whether UDI requirements in Australia should apply to Class I medical devices.
Regulatory authorities in IMDRF members countries all chose a phased-in approach to implementing and enforcing UDI requirements based on several factors, such as device classifications. TGA is proposing staged implementation consistent with the various transitional periods set as parts of Europe’s comprehensive medical device regulation (MDR) and in vitro diagnostic regulation (IVDR).
TGA intends to provide an update based on the feedback received via comments submitted. Suggestions for improvements and alternatives to the proposals, the potential scope of amendments that would be required to establish Australia’s UDI system, as well as stated positions on the body that should be responsible for the Australian UDI database and impact at the company level are some of the types of information that comments on the consultation paper can include.
Separately, TGA also posted two other consultation papers on Monday to propose changes to several definitions and the scope of the medical device regulatory framework and the reclassification of active medical devices for diagnosis and patient therapy. These come in anticipation of the EU’s MDR/IVDR.
