Premier Li Keqiang delivered the Government Work Report on March 5 during the annual plenary session of NPC (National People’s Congress), which reviewed the government work during the past 5 years and also shared the objectives of 2018. He acknowledged the breakthrough of the drug and medical device approval system reform. In addition, the premier emphasized the improvement of supervision by strengthening risk control throughout the entire process, and he underlined the innovative supervision approach that utilizes internet, big data, and more, to realize traceability control as indicated in the 2018 target of Healthy China strategy implementation.
The report reassures China government’s intention of setting up the traceability system and it reminds us to review the “Medical device UDI system regulation draft for comment” published on Feb.27 2018.
Referencing the IMDRF guidance, the US FDA practice and China’s own pilot practice in Shanghai 12 years ago with selected implantable devices, CFDA set up the medical device coding system built- up program and separates that into 3 layers of implementation: Regulation, standard and database. The document that was published in February 2018 explains that the above is to set the general rules including the composition of the Unique Device identifier (UDI), definitions and relevant requirements which together constitute the regulatory basis of UDI system.
Same as in Europe and in the US, the objective of introducing UDI is to strengthen the supervision throughout the entire process including design, manufacturing, distribution and usage, covering all devices sold and used within China. The key definitions, principles as well as the phased implementation strategy based on risk classification are similar to the introduction of the systems in the other key markets mentioned before.
But still, not surprisingly, some differences will be introduced, including:
1) The issuing agency: other than recognizing international agencies, CFDA will draw their own standard, which would introduce another requirement for the companies;
2) It’s clear that the “DI” should be provided within the registration system while applying for device registration and it should be uploaded into the UDI database after receiving the registration within 30 working days; but unlike EU MDR which clearly identifies that the UDI-DI is referenced in relevant certificates according to Annex VI part C, CFDA draft regulation didn’t mention if the UDI will appear on the device registration certificate;
3) The medical device nomenclature is not mentioned within the draft regulation, so it is not clear yet whether some of the global system (e.g. GMDN) will be used or will be linked;
4) Currently, it’s still an “encouragement” of the industry for implementation, and the system is not yet fully mandatory at this stage.
Considering UDI practice will deeply impact the whole industry broadly and China would be definitely a big target market for all players, we would encourage global manufacturers to actively provide your comments to CFDA now: SFDA.gov.cn. As member of UDI Study Group of CSDR (China Society for Drug Regulation) whose target is to draft reports and provide advice to CFDA regulators, Qserve could also be supportive in attracting attention of CFDA regulators.
Please feel free to contact us and tell us your concerns.