China Medical Device classification
Determine the medical device classification
Medical devices are classified into one of three categories in China—Class I, II, and III based on their risk levels. Class I devices are the lowest risk, class II are the ones with moderate risk with technical management and control, and Class III include those with the greatest risk requiring strict control. Determining a proper classification is one of the critical steps in the overall regulatory strategy, as it may lead to different registration routes, submission technical file contents, and clinical requirements.
NMPA Classification Rule and Medical Device Classification Catalogue
NMPA is responsible for categorizing the classification of the medical devices, which is similar to the US FDA system. Although NMPA published Classification Rule (Order No.15 in 2015) to guide medical device classifications at top level, “Medical Device Classification Catalogue” is the main reference document detailing medical devices classifications, product description, generic product name and coding number. Manufacturers need to carefully select a proper classification based on this Catalogue. The mistake on classification selection may greatly impact on the regulatory and clinical (including predicate device) document preparation, and lead to failed submission eventually.
Center for Standardized Supervision
Suppose you may not be able to identify the intended device in the Catalogue, there are two other options to consider. One is to submit the application directly as class III device, and the other is to file the classification application to Center for Standardized Supervision under National Institute of Food and Drug Center (NIFDC) for further assessment. It is advised to follow the second option, as the 1st option will end with the technical reviewer’s request to consult NIFDC opinion in the end. In addition, the Catalogue is dynamically adjusted upon classification consultations from the industry and the ongoing technology and cognitive development. The manufacturer may periodically check the updates.
Class I devices
Class I devices only need to comply with the minimum regulatory requirements and are not subject to technical review by the Chinese health authority. All the test reports validated in the product home country could be directly used. Filling acceptance review is performed by NMPA project management team to check the scope compliance and submission completeness on a high level. There is no application fee or annual company establishment fee applied. The class I certificate does not have validity date either.
Class II and class III devices
Class II and class III devices are subject to technical, quality and clinical review process. A comprehensive set of technical files shall be prepared from product summary to the research document and V&V etc. Local type testing validations for safety and performance are required with qualified test lab and shall meet Chinese applicable standards. Sufficient clinical evidence shall be presented in forms of China specific Clinical Evaluation Reports. The technical review time varies from 120-150 working days. The certificate is valid for 5 years.