Medical network - on February 17, according to the Chinese medicine, the latest news, February 16, 2017 national work conference on the supervision and administration of medical devices in Beijing, both summarize 2016 YiXie supervisory work, has deployed 2017 YiXie key tasks.
National drug safety bureau deputy bureau telephoto red stressed at the meeting, in 2017 the national medical device regulatory work should focus on six aspects:
1, review the examination and approval system reform, go all out to catch quality.
Further deepen the reform, innovation of examination and approval of special medical equipment and priority for examination and approval. Strengthen the technical review guidelines system research, increase the intensity of work, improve the guiding principles for coverage. Pushing forward the construction of the review of the quality management system gradually establish clinical oriented, review as the core of the evaluation system for project team. Establish expert advisory committee, perfect communication system and technology system of dispute resolution. To strengthen the supervision and administration of medical devices clinical trials and carry out product development, clinical trial samples and authenticity verification of registration data. Continue to promote the reform of classification management, efforts to promote medical equipment standards, basic work for the name, code, etc. To promote the implementation of the government purchasing service policy, strengthen the guidance of the provincial medical instrument examination review ability construction, comprehensive assessment.
2, control risks, go all out to catch.
Will strengthen the daily supervision and risk prevention mark moved forward, the integrated use of supervision and sampling inspection, adverse event monitoring, complaint report, public opinion monitoring means, to ensure that the risk in the bud stage. In 2017 to carry out the quality and safety of large sampling in the system, continually expand the scale of sampling observation, active public sampling observation results and treatment of unqualified products. Improve adverse events monitoring work. The regulatory departments at various levels shall practically in accordance with the requirements for the quality control standard, focused, one by one. Continue to strengthen the guidance of specification. We will continue to increase medical instrument flight check and outside check frequency. Strengthen circulation rectification results, keep continuous blow high pressure situation for illegal business behavior. Strengthen the regulation of using link of medical equipment quality.
3, is focused on the prominent question, go all out to catch.
On the one hand, continue to focus on outstanding problems, to carry out rectification. Focus on the production and sale of counterfeit goods, false advertising, exaggerated effect, refurbished resale violation behavior, etc. On the other hand, continue to intensify the case investigation, strengthen the supervision to oversee. Led the handling and administration will continue to improve the mechanism of handling and active handling and cooperate the works of case. Regulatory departments at all levels should strengthen the synergy with local inspection department. Working mechanism innovation, continue to strengthen collaboration with customs, quality supervision, inspection and other related department, with high pressure situation of the law enforcement case, guarantee the quality and safety of medical equipment.
4, to strengthen the construction of technical support ability, go all out to catch.
Continue to increase the intensity of training, technical review staff are encouraged to attend flight check, clinical verification and inspection and quality management system, continuously hone in practice. Establish technical review staff position, rank, compensation management system and the incentive constraints mechanism. Push for examination and approval of the review, audit, inspection, testing and adverse event monitoring mechanism construction and system construction. We will speed up the establishment of a food and drug professional inspector team. In 2017, the administration will be carried out in full system examination skills training. Around to combine skills training, exercise professional inspector team, boost regulators at the grass-roots level to professional inspectors. Further improve the medical device regulatory information support.
5, clear responsibility, go all out to catch.
All in accordance with the unified administration of deployment, earnestly implement the regulatory responsibility of possession. Encourage the related society, association, institutions of higher learning, scientific research institutions to play their respective advantages, work for regulatory developments. Fully give play to the role of the news media, interpretation and communication through strengthening risk, and create a good environment for public opinion. We will continue to improve the medical device regulatory system. To further strengthen international exchanges and cooperation, draw lessons from international regulatory experience, grasp the regulatory laws, enhance supervision effectiveness.
6, strengthen the cultivation of clean government, best catch style.
Regulatory departments at all levels should always put the party's style of the cultivation of clean government in the important position, and strengthen the power of key links and key department, construction of the anti-corruption throughout each business to work. |
