To the food and drug administrations of all provinces, autonomous regions, and municipalities directly under the Central Government and related units:

In order to strengthen the classified management of medical devices, further standardize the relevant work procedures and requirements for medical device classification, according to the Regulations on the Supervision and Administration of Medical Devices and other related regulations, the relevant matters are hereby notified as follows:

 I Work Procedures for Classification Identification

1. The applicant shall determine the category of their products according to the Rules for the Classification of Medical Devices (Order of CFDA, No. 15), Administration of IVD Reagent Registration (Order of CFDA, No. 5), Protocol Amendments on Administration of IVD Reagent Registration (Order of CFDA, No. 30), Announcement of Issuing the Catalogue of Class I Medical Devices (Announcement of CFDA, No. 8 [2014]), Classified Catalogue of Medical Devices (Hereinafter referred to as Classified Catalogue), 6840 Sub-catalogue of Classification of In-vitro Diagnostic Reagents (2013 Edition) and other classification identification notices. For those newly developed medical devices that haven’t been listed in the Classified Catalogue or classification identification notices and whose category shall be defined as per the Article 16 of Regulation on the Supervision and Administration of Medical Devices, the applicant shall submit the application to the classification identification information system of CFDA Medical Device Standards Management Center (Hereinafter referred to as Standards Management Center). See the attachment for specific procedures. The newly developed medical devices that haven’t been listed in the Classified Catalogue or classification identification notices refer to the new product that hasn’t been marketed in China or the medical devices whose technology principle, structure, composition, action site or technical characteristics and intended purpose have undergone substantial changes affecting product classification and which are difficult to be classified according to Classified Catalogue or classification identification notices, compared with products already on the market.

II Other Situations Involving Classification Identification

III Adjustment of Classified Catalogue

This circular shall be implemented since August 1, 2018. Circular of the Office of the CFDA on Further Implementing the Classification Identification Work of Medical Devices (CFDA Department of Medical Device Supervision [2013] No. 36) and Circular of the General Office of the CFDA on Further Strengthening the Classification Identification Management of Medical Devices (CFDA Department of Medical Device Supervision [2015] No. 124) shall be abolished simultaneously.

Attachment: Workflow of medical device classification and definition

General Office of China Food and Drug Administration

September 21, 2017