On February 16, the 2017 National Working Conference on Medical Device Regulation was held in Beijing. The conference implemented the national supervision and administration of food and drugs, commended the advanced conference and the spirit of the working conference on party conduct and honest government construction, summarized the supervision and administration of medical devices in 2016, analyzed the current circumstances and tasks and worked out the work arrangements for medical device supervision focuses in 2017. Jiao Hong, Vice Minister of China Food and Drug Administration (CFDA), attended the meeting and delivered an important speech.
The conference pointed out that the supervision and administration of medical devices in 2016 had made remarkable achievements. Throughout the year, there was no major security and quality incidents of medical devices and the security situation was stable as a whole and continued to improve. In addition, it put forward requirements for the supervision and administration on medical devices in 2017: continue to intensify the review and approval of medical devices and reforms of the review and approval system, concentrate on risk screening and special rectification and unswervingly complete all works for the supervision and administration on medical devices in 2017. It also stressed that the medical device administration is an important part of food and drug administration, as well as an important content of promoting people’s health causes and building a comprehensive well-off society. The food and drug administrations shall look at the bigger picture and plan the supervision and administration of medical devices for the national economic and social development.
Jiao stressed that the medical device regulatory authorities in 2017 would focus on the work in the following 6 aspects:
Advance the review, promote the reforms of the approval system and concentrate on the quality
Further deepen the reforms and earnestly complete special and priority approvals. Strengthen the study on the guideline system for technology approvals, devote greater efforts to writing and increase the coverage of the guidelines. Promote the construction of review quality management system and progressively establish a review system for a project team taking clinical practice as the guidance and review as the core. Establish an expert consultation committee and promote the communication system and technical dispute resolution system. Enhance the supervision and administration of the clinical trials for medical devices, carry out product research and development and conduct authenticity verification of clinical test samples and registration materials. Keep carrying forward the reform of classification management and promote the groundwork for medical device standards, nominating and encoding. Facilitate the implementation of government procurement service policies, strengthen the guidance of the review and approval system construction on provincial medical devices and carry out comprehensive assessment.
Control hidden risks and concentrate on the screening
Strengthen daily supervision, put forward the risk prevention gate and use a combination of means including casual inspection for supervision and administration, monitoring of adverse events, complaint reporting and monitoring of public opinions to nip hidden risks in the bud.
Solve prominent problems and concentrate on the renovation
On the one hand, continue to focus on prominent problems, carry out special rectification, and put emphasis on the prevention and control for illegal behaviors including the production and sales of counterfeited items, misleading propaganda, exaggerated declaration of efficacy and re-sales after renovation. On the other hand, continue to devote greater efforts to investigating cases and strengthen related inspection and supervision.
Strengthening the technical support capability construction and concentrate on the promotion
Continue to intensify relevant trainings and encourage technology reviewers to participate in flight inspection, clinical review and domestic and foreign quality management system review, thus honing their skills incessantly in the practice. Facilitate the construction of position, ranks, salary management system and incentive and restrictive mechanism for technology reviewers. Facilitate the review and approval, auditing and inspection, test and detection and the construction of monitoring agencies for adverse events and relevant systems. Facilitate the team construction of professionals for food and drug inspection.
Define the responsibility and concentrate on the implementation
Follow the unified deployment of CFDA and perform their territorial regulatory responsibilities in real earnest.
Enhance honest government construction and concentrate on the working style
Regulatory authority at all levels must unswervingly give priority to party conduct and honest government construction, strengthen the restriction on the enforcement of rights in the critical stage and major departments and make the anti-corruption and clean government promotion penetrate into each operation and management.
Participants at this conference included representatives from the provincial (regional or municipal) Xinjiang Production and Construction Corps and municipalities with independent planning status, the medical equipment supply devision of Health Bureau of Logistic Support Department of the Central Military Commission, CDFA relevant departments or bureaus and affiliated institutions, technical evaluation institutions and inspection bodies for medical devices in Beijing and other related regions, and related associations and academies.
Zhao Yixin, chairman of CAMDI, along with Xu Shan, deputy secretary general of CAMDI attended the conference.