CAMDI Attends the Symposium on Innovation Development and Evaluation and Approval Reform of Medical Devices

  • 2019-04-02

On March 28, the National Medical Products Administration (NMPA) organized a Symposium on Innovation Development and Evaluation and Approval Reform of Medical Devices to collect the opinions and suggestions from enterprises on the policies for innovative medical devices, so as to understand the implementation of encouraging policies for innovative medical devices and figure out the work direction for further encouraging the innovation development of medical devices. Jiao Hong, Director of NMPA, attended the conference and delivered a speech. Xu Jinghe, Deputy Director of NMPA, presided over the conference.

Enterprise representatives agreed that in recent years, the national medical products supervision authorities have thoroughly implemented the requirements of the Party Central Committee of CPC and the State Council on the acceleration of the evaluation and approval system reform of medical products and devices, and actively carried out Special Review Procedures for Innovative Medical Devices and Priority Approval Procedures for Medical Devices. A number of world-class innovative products developed first in China successively have been approved and come into the market, so the public demands for medical devices have been satisfied further.

Besides, the representatives from eleven enterprises attending the conference also put forward their opinions and suggestions on the problems they met in the innovation development, e.g., strengthening multi-sector and multi-system cooperation to achieve information sharing in the whole chain and preferred use of innovative products in hospitals and to further optimize clinical approval policies. Zhao Yixin, Chairman of China Association for Medical Devices Industry (CAMDI), along with Yang Xiaofang, Deputy Secretary General of CAMDI, also attended the conference. Chairman Zhao, on behalf of CAMDI, gave a speech, in which he put forward three suggestions for promoting the innovation development of medical devices, including: continuing to deepen the reform of innovative evaluation and approval system, optimizing the supervision and management of clinical tests and improving the overall life-cycle management of medical devices.

Finally, Jiao Hong pointed out that as the promotion of the innovation development of medical devices is an important decision made by the Party Central Committee of CPC and the State Council, supervision authorities will steadfastly continue to deepen the reform of evaluation and approval system of medical products and devices. The first, the supervision authorities should continue to strengthen and improve the law and regulation system and speed up the preparation and amendment of Regulations on the Supervision and Administration of Medical Devices and the supporting documents, so as to better meet the demands of enterprises for innovative development. The second, the supervision authorities should energetically carry out regulatory and scientific research, start the regulatory and scientific action plan, and fully mobilize such social resources as authoritative academic institutions and well-known universities, so as to accelerate the development of new standards, tools and ways, improve the quality and efficiency of evaluation and approval, and strive to create a good regulatory ecological environment conducive to innovation-driven development. The third, the supervision authorities should actively follow up the development of international medical device regulation and continue to participate in the research of the related working group of IMDRF, so as to further expand China's international influence on medical device regulation and help China's innovative medical device products to go abroad. At the same time, innovative enterprises should also implement actively the entity responsibilities, focus on the improvement of quality management capacity, establish a good quality management system and keep it effective operation, so as to strengthen the product overall life-cycle management and increase patient follow-up and adverse event monitoring after products come into the market.

Personnel related to Ministry of Science and Technology, Ministry of Industry and Information Technology, and Health Commission, representatives from relevant associations or societies and some enterprises, and main leaders and related personnel of relevant departments and directly affiliated institutions of NMPA, attended the conference.