CFDA deploys 6 aspects of the 2017 Medical Equipment Regulatory Task Force

On February 16, the 2017 National Conference on Medical Device Supervision and Administration opened in Beijing, summarizing the work of medical equipment supervision in 2016 and deploying the key tasks of medical equipment supervision in 2017, according to the latest news from China Medical Daily.
, deputy director of the State Administration of Drug Administration, stressed at the meeting that in 2017 the national medical device regulatory authorities should focus on six aspects of work:
1, promote the reform of the review and approval system, go all out to grasp the quality.
further deepening reform and doing a good job in the special approval and priority approval of innovative medical devices. Strengthen the study of the guiding principle system of technical review, intensify the preparation and improve the coverage of the guiding principles. We will promote the construction of the quality management system for review and gradually establish a clinical-oriented and core project team review system. Establish an expert advisory committee to improve the communication system and technical dispute resolution system. We will strengthen the supervision and management of clinical trials of medical devices and carry out verification of the authenticity of product development, clinical trial samples and registration data. We will continue to push forward the reform of classification management and the basic work of medical device standards, naming and coding. We will promote the implementation of the government's service purchase policy, strengthen guidance on capacity-building for provincial medical device review and approval, and conduct comprehensive assessment.
2, prevention and control of risk hidden dangers, go all out to catch troubleshooting.
strengthen day-to-day supervision, move the risk prevention pass forward, comprehensive use of supervision and sampling, adverse event monitoring, complaints reporting, public opinion monitoring and other means to ensure that the risk is eliminated in the embryonic stage. In 2017, the whole system will carry out quality and safety sampling, expand the scale of sampling, take the initiative to disclose the results of sampling and the handling of non-conforming products. We will effectively promote the monitoring of adverse events. Regulatory departments at all levels should effectively follow the requirements of quality management norms, highlight the key points, one by one. We will continue to strengthen guidance on the implementation of norms by enterprises. We will continue to increase the frequency of medical device flight inspections and overseas inspections. We will consolidate the results of special rectification in the field of circulation and maintain a high-pressure situation of continuous crackdown on illegal business practices. Strengthen the quality supervision of medical devices in the use chain.
3, focus on highlighting the problem, go all out to rectify.
, continue to focus on highlighting problems and carry out special rectification. Focus on the rectification of fake sales, false propaganda, exaggerated efficacy, re-sale and other illegal violations. On the other hand, we will continue to step up investigation and prosecution of cases and strengthen supervision and supervision. The General Administration will continue to improve the mechanism for taking the lead in handling cases, jointly handling cases, taking the initiative to handle cases and cooperating with cases. Regulators at all levels should strengthen coordination with local inspection departments. Innovative case handling mechanism, continue to strengthen cooperation with customs, quality inspection and other relevant departments to law enforcement of the high-pressure situation, to ensure the quality and safety of medical devices.
4, strengthen technical support capacity-building, go all out to improve.
continue to step up training efforts to encourage technical reviewers to participate in flight inspection, clinical verification and internal and external quality management system verification, and continue to hone in practice. We will promote the establishment of positions, grades, compensation management systems and incentive and restraint mechanisms for technical reviewers. We will promote the construction of institutions for review and approval, audit and inspection, inspection and testing, and monitoring of adverse events. We will accelerate the construction of professional inspectors for food and medicine. In 2017, the General Directorate will conduct system-wide training in inspection skills. All regions should combine skills training, training professional inspectors, to promote the grass-roots supervision personnel to professional inspectors. Further improve the medical device supervision information support.
5, clear the responsibilities of all parties, and make every effort to implement.
in accordance with the unified deployment of the General Administration, and effectively implement the responsibility of territory supervision. Relevant societies, associations, institutions of higher learning and scientific research institutions are encouraged to give full play to their respective advantages and make suggestions for regulatory work. Give full play to the role of the news media, through strengthening risk interpretation and communication, to create a good environment for public opinion. We will continue to improve the regulatory system for medical devices. We will further strengthen international exchanges and cooperation, learn from international regulatory experience, grasp the laws of supervision and enhance the effectiveness of supervision.
6, strengthen the construction of clean government, go all out to grasp the style.
regulatory departments at all levels should always put the construction of a clean and honest government in an important position, strengthen the restrictions on key links and key departments in the operation of power, and carry anti-corruption and clean construction throughout the various business work. (Sina Pharmaceuticals)