On Dec 21, 2015 China Food and Drug Administration ( CFDA ) issued the ‘The rule of setting medical device’s generic name’, which would be put into effect on 1 April, 2016. The purpose of this document is to regulate the generic name of medical device to be sold in China, therefore the users can easily identify the functions of the device. It defines the key elements to form a medical device’s generic name in Chinese characters, and which words should not be used.
The newly published ‘The rule of setting medical device’s generic name’ is the foundation of CFDA nomenclature system, in which CFDA is planning to include a ‘Generic Name Terminology Guidance’ and a ‘Generic Name Catalogue’ database. The nomenclature system, the device classification system and the to be revealed UDI system would become the pillars of CFDA’s new regulatory framework.
Since the introduction of new regulatory framework and the publication of the updated classification catalogue in 2014, we have seen CFDA tightening the requirements on product generic names. The new norm is that product name has to be exact / word to word match to the names listed in the classification catalogue or names listed in the clinical trial exemption list for the product to be qualified accordingly. This new practice has caused lots of confusions among manufacturers on how to choose their Chinese product names, since it is now closely related to the device classification, clinical trial exemption and reimbursement, etc.
The new rule is expected to provide clarifications to practices. It is mandated only generic names can be used for the identification of medical devices. So for companies already in the Chinese market, although the transition period has not yet been announced, it is time to find out what would be the Chinese generic name of your product. Please note, changing product name requires a technical variation application to CFDA, and the CFDA timeline for processing variation application is approximately 6 months (Class II) to 8 months (Class III) at the moment.
Based on the above information, it is clear that for medical device registration in China, selecting the appropriate Chinese generic name has now become a critical element in regulatory strategy.
*Together with the announcement of the new naming rule, CFDA has also officially clarified that use / change of commercial name / trade name no longer requires approval from or notification to CFDA.
Want to learn more? Steven Wen, Brandwood Director of China Operations will be presenting at the Asia Pacific Devices Summit in San Francisco, CA, March 10-11. Why not join us and meet Steven face to face. The summit features in-depth presentations from leading Asian experts in regulatory, reimbursement, clinical trials and much more. It’s a must attend event for anyone serious about succeeding in Asia. Don’t miss out Register now.