CAMDI Organizes Symposium on Collecting Opinions for Regulation on the Supervision and Administration of Medical Devices

  • 2019-06-14

On the afternoon of June 13, 2019, China Association for Medical Devices Industry (CAMDI) organized a symposium on collecting opinions of the Regulation on the Supervision and Administration of Medical Devices (Revised Draft) (Exposure Draft) (hereinafter referred to as the Regulation). Seven representatives from the Department of Policy and Regulation, Department of Medical Device Registration and Department of Medical Device Supervision of National Medical Products Administration (NMPA) were invited to the symposium to pool suggestions of the panel discussion. A total of 15 domestic and foreign member enterprises of the CAMDI regarding manufacturing, operation and circulation of medical devices participated in this symposium. Fan Xiaodong, vice president of CAMDI, Yang Xiaofang, deputy secretary-general of CAMDI, Hu Huihui, director of CAMDI attended the event. The symposium was held by Yang Xiaofang.

Centering on the Regulation, the symposium was carried out to give full play to the guiding role of CAMDI, collect opinions in the industry and strengthen communication with the governments. In the symposium, Mr. Fan first expressed his heartfelt thanks to the heads of NMPA and all the enterprises for their substantial support. He hoped that everyone could speak out freely before the establishment of the Regulation and strictly comply with it after the promulgation. The participating enterprises held a heated discussion about the Regulation and put forward nearly 90 suggestions and opinions from wording to industry norms, unspoken rules in the sector, technical standards, evaluation indicators and other common and individual issues, with a view to jointly promote the revision of the Regulation. Mr. Fan also showed his gratitude to CAMDI for its active response and timely organization of the symposium. He hoped that more such activities could be organized in the future to gather collective wisdom and efforts of all participants.

Heads of Department of Policy and Regulation said that CAMDI has played an excellent role in building a bridge between governments and enterprises and has also provided many favorable opinions and suggestions with reference value in the process of legislation. A great deal of attention and emphasis from the industry has been placed on the revision of the Regulation. The opinions and suggestions proposed by all the participants are valuable, which can be used as the reference to the draft revision in the next step. During the revision, the NMPA will give full consideration to the opinions and suggestions from all the participants and actively accelerate the release of regulations.