The China Food and Drug Administration (CFDA) announced, on 31 August 2017 the final revision to the 2002 Medical Device Classification Catalogue. The new catalogue, which significantly updates device classifications and will have considerable impact on device registration, manufacturing and distribution, will become effective on 1 August 2018.
All medical devices marketed or sold for use in China must be registered with the CFDA. While there are many similarities with registration requirements in the US and EU, the classification of medical devices in China includes some important deviations from classification schemes in other countries.
The Medical Device Classification Catalogue divides medical devices that are marketed or sold for use in China into three classes depending on the level of risk they present to patients or users. It is one of the most important documents for regulating China’s medical device industry, which was worth US$53.62 billion in 2016.
Medical device companies must undergo different registration procedures depending on the classification listed in the catalogue: Class I registrants only have to record-file with the municipal level Food and Drug Administration; Class II registrants must be examined and approved by provincial authorities; and Class III registrants must be examined and approved by the state-level CFDA.
As a result, Class I device registration usually takes about 10 to 15 months, while Class II and Class III registrations can take up to 24 months. Applicants with devices that are not currently covered in the catalogue or in the CFDA’s device classification notices must submit device classification applications to an expert panel for adjudication.
The new catalogue reduces the number of device catalogues from 43 to 22, according to the functions and clinical uses of the medical devices. Each catalogue contains primary type, sub-type, device description, intended use, device examples and classification (I, II & III). The new catalogue also downgrades the risk level of 40 types of devices from Class III to Class II or Class II to Class I, while upgrading certain types of devices to Class III.
The new catalogue also reclassifies the existing 260 device types into 206 primary types, which are further subdivided into 1,157 sub-types of products. To provide clear guidance to device applicants who want to classify a specific device, it adds a detailed description of the device features and intended uses for each sub-type. The new catalogue also provides 6,609 product name examples, against the 1,008 listed in the 2002 catalogue.
Medical device companies should check whether the new catalogue reclassifies any of their current product portfolio and make corresponding preparations to conform to the new standards before they come into force. The new catalogue is not applicable to any combination device products, while in vitro diagnostic (IVD) reagents are classified separately in a specialised IVD sub-catalogue issued by CFDA in 2013.
The CFDA has also issued a circular (CFDA Order [2017] No.143) to provide guidance to medical device companies in respect of reclassification issues arising from the new catalogue during the device registration application or renewal process.
Further important legislation governing the medical device industry includes the Regulations on Supervision and Administration of Medical Devices (State Council Order No. 680), which came into effect earlier this year, and the Catalogue of Industries for Guiding Foreign Investment, which regulates what types of medical devices are permitted, restricted or encouraged for foreign investment in China. The latest version was released in June this year.
For importers, the registration process requires the submission of a registration standard along with device samples for testing. Manufacturers of Class II and Class III medical devices are also required to demonstrate that the device has been approved by the country of origin and may also be required to submit clinical data in support of their application.
In addition, all medical device manufacturers must also include product information in Chinese on all packaging and labelling. The term of validity for the registration certificate for medical devices is generally five years and the holder of the certificate must apply for re-registration within six months before the certificate expires. The CFDA will decide within 90 working days if the product can be registered, counting from the date of acceptance of the application.
Manufacturers exporting medical devices to China must appoint several China-based agents to act on their behalf. These include a registration agent to coordinate the CFDA registration process, a legal agent to handle any adverse events reported with a registered device, including a product recall, and an after sales agent to provide technical service and maintenance support.
In addition to the CFDA, the Centre for Medical Device Evaluation (CMDE) is responsible for conducting the dossier review during the medical device registration process and the General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ) conducts mandatory safety registration, certification, and inspection for certain devices.
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