According to the overall arrangements by China Food and Drug Administration (CFDA) for management reforms of medical devices classification, CFDA launched the revision of The Classification Catalogue for Medical Devices in July 2015. The Classification Catalogue for Medical Devices is a crucial regulatory document for medical devices, involving production, management, use and regulation, and serves as the foundation for regulatory supervision of medical devices. To solicit suggestions from the medical device industry on the revision of The Classification Catalogue for Medical Devices, Department of Medical Device Registration of CFDA held a seminar in Beijing from November 10 to 11, 2016 on The Classification Catalogue for Medical Devices (Revised Draft).

Commissioner Wang Lanming, Deputy Director Gao Guobiao and related personnel of Department of Medical Device Registration, Dr. Jiang Feng, executive vice chairman of China Association for Medical Devices Industry (CAMDI) and leaders of CFDA Center for Medical Device Evaluation (CMDE) and CFDA Center for Medical Device Standardization Administration together with 60 representatives of enterprises attended the seminar and made in-depth exchanges regarding The Classification Catalogue for Medical Devices (Revised Draft) and related suggestions for the implementation.

At the seminar, Commissioner Wang introduced to the attendees the general plan for management reforms of medical devices classification and the background of revision for The Classification Catalogue for Medical Devices (Revised Draft). Dr. Jiang Feng said CAMDI attached great importance on and participated in the revision for The Classification Catalogue for Medical Devices. At CFDA’s urgency, suggestions for the revision has been extensively solicited among corporate members. Participating enterprise representatives involving Shanghai United Imaging Healthcare Co., Ltd., Medtronic Inc., Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Becton Dickinson, Yuwell-Jiangsu Yuyue Medical Equipment & Supply Co., Ltd., Johnson & Johnson Medical (China) Ltd., Shandong Xinhua Medical Instrument Co., Ltd., Beijing Aeonmed Co., Ltd., Shanghai Wicresoft Co., Ltd. and Thermo Fisher Scientific gave suggestions for The Classification Catalogue for Medical Devices (Revised Draft) in terms of their interested products. Deputy Director Gao said at the seminar that CFDA would record as well as order, collect and research afterwards these suggestions from each enterprise representative and would also take suggestions from hospitals and scientific research institutions in the near future to revise The Classification Catalogue for Medical Devices early and further consolidate the management of medical devices classification.