On January 17, the 14th Meeting of International Medical Devices Regulations Research Group was held in Beijing. Jiao Hong, deputy director of China Food and Drug Administration (CFDA), attended the meeting and made a speech.

At the meeting, the Device Registration Department of CFDA introduced the research advancement in international medical device regulations of CFDA as well as its attendance at the 10th administration committee meeting of International Medical Device Regulators Forum (IMDRF). Nine groups of International Medical Devices Regulations Research Group reported the project tracking and their attendance at IMDRF, involving data specification on medical device registration and submission, good review practices of medical devices, common data elements within the medical device life cycle, medical device stand-alone software, medical device regulatory authorities, evaluation on patient registration data in medical institutions, terms and codes of medical device adverse events, international standards for medical devices and quality management system of medical devices. In 2018, China will assume the rotating chairman of IMDRF. Accordingly, the International Cooperation Department reported on the preparations made for the performance of rotating chairman duty.

Jiao Hong affirmed their achievements in the international regulation research of medical devices. Jiao pointed out that since China joined the IMDRF in 2013, the International Medical Devices Regulations Research Group established by CFDA has made positive contributions to the research on international advanced experience of medical device administration, improvement in medical device administration and promotion in the speaking right and international prestige of China in the field of international medical devices. At present, the medical device regulatory system in China has been basically built. CFDA will combine with the national condition of China, comply with the international trend of the regulation, further promote the assessment on medical devices, examine and approve institutional reforms, constantly strengthen post-market regulation, boost the team growth of professional reviewers and inspectors and promote the healthy development of the medical device industry.

Jiao stressed that CFDA paid high attention to international regulatory cooperation of medical devices. Therefore, CFDA will continue to enhance the research on international medical device regulations, substantially participate in the international regulatory coordination and strive to play a leading role in some projects of the international regulatory coordination. Moreover, they will make preparations for the performance of the rotating chairman duty of IMDRF in 2018, show the medical device regulation ability and level of China and involve and benefit more medical device enterprises.

The participants of the meeting include responsible persons from Device Registration Department, Device Supervision Department, International Cooperation Department, the National Institute for the Control of Pharmaceutical and Biological Products (NICPBP), Center for Food and Drug Inspection, Center for Drug Reevaluation, Center for Medical Device Evaluation, Center for Food and Drug International Exchange, China Association for Medical Devices Industry (CAMDI) of CFDA and related personnel.