China Food and Drug Administration (CFDA) released new "Classification Catalogue for Medical Device" (as "New Catalogue" for short) on August 31, 2017, this New Catalogue will be implemented on August 1, 2018.
The new 2017 Revision New Catalogue is in order to implement the requirements of the Regulation for the Supervision and Administration of Medical Device Classification System, solidly promote reform of Medical Device Review and Approval System in CFDA. The New Catalogue doesn't contain the contents of the Classification Sub-Catalogue for 6840 In Vitro Diagnostic Reagents (2013 Edition) and Categories of Combination Products. It doesn't include Class I Medical Device Filing Categories.
The New Catalogue is simplified and integrated from previous 43 sub-catalogues to 22 Sub-catalogues to make it a more reasonable framework and clearer hierarchical structure, subdivided from previous 260 product categories to 206 first-level product categories and 1157 second-level product categories, added product Intended Use and Product Description for each product category and expands the number of product samples from 1008 to 6609.
In New Catalogue, Medical Device are degraded from Class III to Class II, examples are, Gastrointestinal contrast agent, Gastrointestinal Ultrasonic Imaging Powder, Radioactive nuclide scanning device, Endoscope Balloon Controller, Irrigation Pump for Radiofrequency Ablation Instrument, X-ray Image Processing Software, Nuclear Medicine Workstation Software, MRI Imaging Analysis Software, and some devices in "22 Clinical Analysis Instruments", etc..
Devices are degraded from Class II to Class I, examples are, LED Surgical Light, Optical Zooming Device of Medical Use with LED Source, some devices in categories of "04 Orthopedic Surgical Instruments", "14 Infusion, Nursing and Protective Devices", "17 Dental Devices" and Plate Washer from "22 Clinical Laboratory Devices", etc.
Devices are degraded from Class I to non-medical device, examples are, Medical Information Management Software, Tele-medicine Software, Patient Bed for Radiotherapy Devices, Infusion Workstation in Category of "14 Infusion, Nursing and Protective Devices", etc.
Seldom devices are upgraded, one is upgraded from Class I to Class II called Brain Spatula in Category " 03 Surgical Instruments for Nerve and Blood Vessel Surgeries", another one is upgraded from Class II to Class III called Active Breathing Control System in Category " 05 Radiotherapy Devices".
The new CFDA Classification Catalogue is the basis for monitoring Medical Device Registration, Production, Distribution and Usage. In transition period, the manufacturers need to double check if their products have classification changes especially the products made in China.
If you are interested in the CFDA New Classification Catalogue related issues, please contact me with julianiu@ramed.top for questions or more detailed information.