A Publicizing and Implementation Meeting on the Reform of Medical Devices Evaluation and Approval System held by China Food and Drug Administration

  • 2017-11-14

China Food and Drug Administration held the publicizing and implementation meeting on national reform of medical devices evaluation and approval system on November 9, 2017 in Shanghai. The meeting was held for publicity and implementation of Opinions on Deepening the Reform of Evaluation and Approval System to Encourage Innovation in Drugs and Medical Devices, interpretation of the opinions, unity in thinking, making joint efforts and deepening the reform of medical devices evaluation and approval system. Jiao Hong, Deputy Director of China Food and Drug Administration, attended the meeting and gave a speech.

Jiao Hong pointed out that the release of the Opinions embodies the strong determination of the Party Central Committee and the State Council to ensure the safety of medicines and medical devices. The current medical device industry and management in China cannot meet the needs of the public for quick, safe, high-level and high-performance medical devices and great improvement of diagnosis and treatment. Jiao Hong urged everyone to have a strong sense of responsibility and a sense of mission, fully understand the importance of deepening the reform of evaluation and approval system, accurately understand the key requirements of the reform, strengthen organization and leadership, take initiative, respect science, and promote the effective implementation of the reform.

At the meeting, the heads of the Legislation Division, the Medical Device Registration Division, the Medical Device Supervision Division, the Center for Medical Device Evaluation and the Center for Medical Device Management introduced the amendment to The Regulation on the Supervision and Administration of Medical Devices, the measures to encourage innovation and deepen reform, the full life cycle management of medical devices, the reform of evaluation institutions and standard classification. The assessment of medical device evaluation and approval capacity at provincial level was also introduced at the meeting. The representatives present at the meeting discussed the content of the reform and agreed that the meeting was timely held and the spirit of the reform has been conveyed. The meeting also interpreted the reform policies in detail and laid a solid foundation for the following work of the reform.

About 140 representatives attended the meeting, including the persons in charge of medical device supervision and administration of food and drug administration of all provinces (autonomous regions and municipalities), and the heads of relevant departments and divisions of and units directly under China Food and Drug Administration.