On the evening of December 20, 2022, the "China International Medical Device Regulatory Forum (CIMDR) - Global Harmonization Working Party (GHWP) Session & International Drug Regulatory Authorities Dialogue" was held online. Mr Xu Jinghe, Deputy Commissioner of the National Medical Products Administration (NMPA), attended the meeting online and delivered keynote speech.
Xu said that the Chinese government has always been adhering to the people's supremacy and life's supremacy. While attaching great importance to the quality and safety of medical devices, NMPA has taken a series of measures to encourage and support the innovative and high-quality development of the medical device industry. In recent years, according to the requirements for basing on a new development stage, implementing a new development concept, and building a new development pattern, NMPA has always been committed to the lofty mission of protecting and promoting public health. Specifically, NMPA has vigorously strengthened the construction of medical device regulations and systems, continuously deepened the reform of the medical device evaluation and approval system, and steadily conducted studies on the regulatory science of medical devices. In addition to comprehensively promoting the capacity building of medical device regulation and continuously strengthening the full life cycle quality regulation of medical devices, NMPA has also actively participated in international exchanges and cooperation, striving to vigorously advance the scientificity, legalization, internationalization, and modernization of the regulatory work. The ultimate goal is to accelerate the marketing of multiple innovative and clinically urgent products, thus better meeting the health needs of the public.
Xu pointed out that NMPA has always been deeply involved in the work of GHWP over the years, striving to contributing more to the global development of medical device regulation in its own process of internationalization and constant development. Adhering to the concept of openness, inclusiveness, and win-win cooperation, NMPA will continue to actively support more members to join GHWP in the future, striving to promote the transformation and implementation of relevant guidelines in member countries and advance the regulatory capacity building of all members. In addition, NMPA will also strengthen studies on regulatory development strategies, so as to help GHWP develop to a higher level, thus making greater contributions to the global harmonization of medical device regulations and the safety, effectiveness, and accessibility of various products.
As an important international organization for the global harmonization of medical device regulations, GHWP has built a pragmatic and efficient communication platform for global medical device regulatory authorities and industry representatives. Dr. Al-Dalaan, the current Chairman of GHWP and Vice Executive President on Medical Devices Sector of the Saudi Food & Drug Authority (SFDA), attended the meeting online and delivered opening address. Relevant technical experts gave a comprehensive introduction to the latest progress of GHWP in regulatory harmonization from the perspectives of artificial intelligence (AI), remote inspection, quality management system, unique device identifier (UDI), etc. Representatives from regulatory authorities of some countries also attended the meeting online, including the Federal Service for Surveillance in Healthcare Russia, the South African Health Products Regulatory Authority (SAHPRA), the Saudi Food & Drug Authority (SFDA), Badan Pengawas Obat dan Makanan (BPOM) Indonesia, Egyptian Drug Authority (EDA), Moroccan Ministry of Health and Social Protection, etc. They shared their experience in the development of the medical device industry, regulatory governance, regulatory reliance, and international cooperation of their own countries. Nearly 600 industry representatives from China Association for Medical Devices Industry (CAMDI), Asia Pacific Medical Technology Association (APACMed), etc. attended the meeting online.
In addition, relevant principals of the Department of Science, Technology and International Cooperation of NMPA, Department of Medical Device Registration of NMPA, Department of Medical Device Regulation of NMPA, Center for Medical Device Evaluation of NMPA, Center for Food and Drug Inspection of NMPA, and China Center for Food and Drug International Exchange also participated in the meeting.