How to define the category of medical device

The first priority of medical device company is to define the category of medical device. Then how to define the category of medical device?
China carry out the policy of classification administration of medical devices, and the medical devices are divided into three kinds as Class I, Class II and Class III according to the degree of risk. The manner of defining determinism has followed several ways：

CFDA website will publish the catalogue of medical devices classification and notification of product classification non-scheduled. You can find the basic information of the product which has been registered or recorded by searching the CFDA database, and define the category by learning the related products.

The provisions are meant to direct the formulation of《Catalogue of Medical Device Classification》 as well as to determine the classification of newly registered products. CFDA has issued the《Provisions for Medical Device Classification》(CFDA No.15) on Jul 14, 2015, and the provision shall put in force from Jan 1, 2016, also abolish the《Provisions for Medical Device Classification》promulgated on Apr 5, 2000 (the former State Food and Drug Administration decree No.15) shall be repealed simultaneously. The decision table of medical device classification of《Provisions for Medical Device Classification》provide the standard of determination of product category.

Note: Classification information system is refer to Information System of medical devices Classification Definition

Classification is the first step of medical device towards marketing. CIRS has collecting the classified catalogue, notification of classified definition and exposure draft of classification which published by CFDA over the years, and form a classified catalogue system of medical device which can help you search the category of your product. CIRS has a great deal of experience in technical documentation of classified definition, and has completed the classification of multiple products.
For the new product which has not been listed in the classified catalogue yet, you can apply for classification or apply for registration as Class III medical device. Company can make a choice according to the actual conditions.