ARTICLE SUMMARY:
In this week's top news pick from MedTech Strategist Market Pathways: China takes notable steps toward establishing a unique device identification program.
Pushing ahead efforts to establish a unique device identification system has been a major focus of Chinese regulators in recent months. The country’s National Medical Products Administration took a big step last week with the release of a new rule to outline UDI requirements, which will officially take effect October 1.
As are other countries, China is adopting UDI as a means to better track devices, monitor safety, and improve data collection in general for devices. UDIs mean new labeling and database requirements for device companies. The new rule (link in Chinese) outlines steps for device companies to select China-based coding agencies, assign UDIs, submit UDI and device information to an electronic database, and to make updates to the UDI database when necessary. It also lays out standards for local UDI coding agencies.
In practice, NMPA is taking a step-by-step approach to implementation, starting with higher-risk implantable and interventional devices, which are the subject of a one-year UDI pilot program that was launched in July. More than 100 device companies, including multinationals and China-based firms, and another 100-plus hospitals are participating in the pilot to build a UDI infrastructure. In conjunction with issuing the rule, a new working group was unveiled August 27 consisting of NMPA officials and leaders from other Chinese agencies to organize and troubleshoot the UDI pilot program.
China’s UDI timeline is not far off Europe’s, which is getting set to launch UDI as part of the implementation of its Medical Device and IVD Regulations. Europe has more fixed dates in place for mandating UDIs on labels and devices depending on risk, with the first requirements for high-risk devices kicking in in May 2021. US FDA enacted its UDI program in 2013, and since then has rolled out UDIs to most, but not all, device classes. Harmonized UDI requirements are a major goal of regulators, but different authorities are expected to include some distinctive UDI features to meet national needs.
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