The China Food and Drug Administration (CFDA) has recently released a long-anticipated draft Classification Catalogue of Medical Devices (Draft Catalogue). The Draft Catalogue updates a 2002 Classification Catalogue (Current Catalogue) and is one of the final pieces in the reform of China’s medical device system that has taken place since the 2014 revision of the framework regulation — the Medical Device Supervision and Administration Regulations (MDSAR).
Further indicating that this revision has become a priority and that finalization of the draft may come soon, just before the end of the comment period, on November 25, 2016, the CFDA convened a seminar of foreign and domestic manufacturers, health care professionals, and food and drug regulatory officials to discuss how to further improve the Draft Catalogue.
Like in the United States, medical devices in China are divided into three risk-based classes. The class of the device determines parts of the application process for marketing approval. An applicant can either determine the class of its device using the catalogue, notices updating it, and general rules on classification that CFDA revised last year, or it can default to Class III (the highest risk class).
A criticism of the Current Catalogue is that it is outdated and that it does not provide clear guidance to applicants seeking to make a classification decision. CFDA has issued scattered notices to classify or reclassify devices, yet the Current Catalogue does not include product descriptions and intended uses for a specific category of the product. Considerable overlap also exists among the categories, which leads to inconsistent determinations.
The Draft Catalogue proposes four significant revisions.
First, it would reduce the number of sub-catalogues to 22 from the original 43 in accordance with the functions and clinical uses of medical devices.
Second, it would re-classify the current 265 entries of products into 205 primary categories, and further subdivides the 205 primary categories into 1,136 sub-categories of products.
Third, for each sub-category, the Draft Catalogue also adds a detailed description of the product features and intended uses for those products. It also includes a product example column with 4,500 example products for each sub-category of devices.
Fourth, the Draft Catalogue down-classifies 19 sub-categories of products in the Draft Catalogue. For example, the x-ray image processing system and Nuclear Magnetic Resonance Imaging system have been down-classified from Class III to Class II.
An example entry from the Draft Catalogue would read as follows:
|Sub-Catalogue 21||Medical Software|
|05 Primary Category||In vitro diagnosis (IVD) software|
|0502 Sub-Category||Screening and analysis software|
|Product Description||The product usually consists of CD (or installation application downloaded from the Internet websites) and/or an encryption lock. It analyzes and calculates the clinical, biochemical, immunological data for the purpose of disease diagnosis, evaluation and so on.|
|Intended Use||Used for disease diagnosis and evaluation|
|Prenatal screening analysis software, Down syndrome (DS) and neurological defects (NTD) prenatal screening analysis software . . . blood glucose data analysis software|
Several other points are worthy to note. The Draft Catalogue does not cover IVD devices, which have a separate sub-catalogue that CFDA issued in 2013. CFDA also stated that it is not revisiting its prior determinations that certain products are not medical devices. CFDA made these determinations in the individual ad hoc notices discussed above.
On the much-discussed issue of mobile apps, CFDA indicates in an explanatory note that it does not plan to create a separate sub-catalogue or category for these products. However, mobile apps can fit into the category for software. In the new medical software section, the Draft Catalogue lists five primary categories—namely, treatment planning software, image processing software, data processing software, in IVD software, and decision support software—and a catch-all entry. Depending on the use of the mobile app (e.g., processing clinical data or images), it might be classified as “image processing software” or “data processing software.”
Public news suggests that the Draft Catalogue may even be finalized by the end of the year. We will continue to monitor the development of this Draft Catalogue.