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:
1. Work Procedures for Classification Identification
2. Other Situations Involving Classification Identification
3. Adjustment of Classified Catalogue
(Nine) The Center for Medical Device Standard Management will establish an open classified catalogue database in due course and maintain it based on the product listing information and the result of previous classification identification through sorting of the product name and description, intended use, product category and classification code.
(Ten) The departments and units related to the General Office and food and drug administrations at provincial level can put forward the suggestions for the adjustment of the Classified Catalogue and feed back to the Center for Medical Device Standard Management. The Center for Medical Device Standard Management analyzes and evaluates the risk changes of medical devices. If necessary, it organizes the Technical Committee on Classification of Medical Devices to put forward suggestions on the adjustment of medical devices management category. After the review by the General Office, the Center for Medical Device Standard Management will adjust the classified catalogue database.
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: Work Procedures for Classification Identification of Medical Devices
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:
1. Work Procedures for Classification Identification
2. Other Situations Involving Classification Identification
3. Adjustment of Classified Catalogue
(Nine) The Center for Medical Device Standard Management will establish an open classified catalogue database in due course and maintain it based on the product listing information and the result of previous classification identification through sorting of the product name and description, intended use, product category and classification code.
(Ten) The departments and units related to the General Office and food and drug administrations at provincial level can put forward the suggestions for the adjustment of the Classified Catalogue and feed back to the Center for Medical Device Standard Management. The Center for Medical Device Standard Management analyzes and evaluates the risk changes of medical devices. If necessary, it organizes the Technical Committee on Classification of Medical Devices to put forward suggestions on the adjustment of medical devices management category. After the review by the General Office, the Center for Medical Device Standard Management will adjust the classified catalogue database.
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: Work Procedures for Classification Identification of Medical Devices
General Office of China Food and Drug Administration
September 21, 2017
September 21, 2017