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    China's medical device standard system continues to improve

    Click:116 Time:2020-05-14 14:32:30

        医疗器械标准是医疗器械研制、生产、经营、使用以及监督管理所共同遵循的技术规范,是医疗器械监管和产业发展的重要技术支撑。国家药监局高度重视医疗器械标准工作,按照“四个最严”的要求,结合医疗器械产业发展和监管工作实际,不断完善医疗器械标准管理制度体系、持续开展医疗器械标准制修订工作,我国医疗器械标准体系不断完善,医疗器械标准对监管和产业发展的技术支撑能力持续提升。

      一、加强医疗器械标准制度建设

      为贯彻落实国务院深化标准化改革重大决策部署,依据《中华人民共和国标准化法》,立足我国医疗器械产业发展和监管工作实际,2017年4月,原食品药品监管总局修订印发《医疗器械标准管理办法》,该办法的出台对指导我国医疗器械标准管理、规范标准制修订、促进标准实施、提升医疗器械质量等起到了积极作用。为贯彻落实《医疗器械标准管理办法》,原食品药品监管总局先后印发《医疗器械标准制修订工作管理规范》和《医疗器械标准报批发布工作细则》等文件,进一步规范了医疗器械标准工作程序,强化了标准精细化过程管理,为提升医疗器械标准质量奠定了坚实的制度基础。

      二、加快医疗器械标准制修订工作

      持续实施医疗器械标准提升计划,“十二五”“十三五”期间,每年组织制修订100项左右医疗器械标准,对重大基础性标准、通用性标准、高风险产品标准、战略新兴产业相关领域标准优先立项。2018年,遴选确定99项医疗器械行业标准制修订项目,审核发布医疗器械行业标准104项,截至2018年底,我国医疗器械标准共1618项,其中国家标准219项,行业标准1399项。我国医疗器械标准与国际标准一致性程度达到90%以上,标准体系的覆盖面、系统性不断加强,医疗器械标准的整体水平不断提升。加大标准公开力度,建立医疗器械标准公开信息平台,实现强制性医疗器械行业标准文本和推荐性医疗器械行业标准目录信息100%公开。

      三、完善医疗器械标委会体系和管理

      积极推动战略性新兴医疗器械相关标委会筹建,在现有24个医疗器械标准化(分)技术委员会的基础上,结合医疗器械产业发展实际,2018年积极筹建全国外科植入物和矫形器械标准化技术委员会有源植入物分技术委员会、全国医疗器械生物学评价标准化技术委员会纳米医疗器械生物学评价分技术委员会和医用电声设备、医用增材制造技术、人工智能医疗器械3个医疗器械标准化技术归口单位,进一步完善医疗器械标准组织体系建设。

      四、提升医疗器械标准国际话语权

      深度参与并推动国际医疗器械监管机构论坛(IMDRF)标准工作组相关活动,2018年,在IMDRF第13次管理委员会会议上,我国提出的“更新IMDRF成员认可国际标准清单”新工作项目获得一致赞成通过,实现了我国从参与到主导医疗器械国际标准认可规则制定的历史性突破。首次主导制定高性能医疗器械国际标准,在2017年国际外科植入物标准化委员会(ISO/TC150)年会上,《心血管植入物 心脏封堵器》国际标准提案获得立项通过,是我国首个医疗器械行业标准转化为ISO国际标准,对推动我国医疗器械标准的国际化进程具有重要的开创性意义,有力提升了我国医疗器械领域的国际话语权,促进了我国标准与国际接轨。



    Medical device standard is a common technical standard for medical device research, production, operation, use and supervision and management. It is an important technical support for medical device supervision and industrial development.State food and drug administration attaches great importance to the standard work of medical equipment, according to the requirements of "the four most strict", combining the reality of medical equipment industry development and regulatory work, constantly improve the system of medical instrument standard management system, continued to carry out the standard system revision work of medical equipment, continuously improve the medical devices standards system in China, the development of medical instrument standard of regulation and industry technical support ability to continue to ascend.

    First, strengthen the construction of medical device standard system

    To implement the major decision deployment deepening the reform of standardization under the state council, on the basis of the standardization law of the People's Republic of China, based on the development of China's medical equipment industry and regulatory work reality, in April 2017, the original issued by the food and drug supervision bureau revised the measures for the administration of medical devices standards, introduced the way to guide the national standards of medical equipment management, standard system revision, promote standard implementation, such as improving the quality of medical equipment has played a positive role.For the implementation of the "measures for the management of medical equipment standard", the food and drug supervision administration has issued by the medical devices standards work management and revising rules and the examination and approval of the medical devices standards published work detailed rules "and other documents, and further standardize the medical equipment standard work procedures, strengthening the management of the standard process of refinement and for improving the quality of medical devices standards system laid a solid foundation.

    Accelerate the revision of medical device standards

    We will continue to implement the plan to upgrade standards for medical devices. During the 12th Five-Year Plan period and the 13th Five-Year Plan period, we will organize the formulation and revision of about 100 standards for medical devices every year, and give priority to the approval of standards for major basic standards, universal standards, high-risk products, and standards in areas related to strategic emerging industries.In 2018, 99 medical device industry standards were selected and revised, and 104 medical device industry standards were reviewed and released. By the end of 2018, China had 1,618 medical device standards, including 219 national standards and 1,399 industrial standards.The consistency between China's medical device standards and international standards has reached over 90%. The coverage and systematicness of the standard system have been continuously enhanced, and the overall level of medical device standards has been constantly improved.We will strengthen the disclosure of standards, establish a platform for the disclosure of medical device standards, and achieve 100% disclosure of mandatory medical device industry standard text and recommended medical device industry standard catalog information.

    3. Improve the system and management of medical device Standards Committee

    Actively promote strategic emerging medical equipment related standard council planning, the existing 24 medical apparatus and instruments, on the basis of standardization technical committee (points), according to the development of medical equipment industry, actively planning the national 2018 surgical implants and orthopedic devices standardization technical committee active implants technical committee, the national biological evaluation of medical devices standardization technical committee of nano biological evaluation of medical devices technical committee and medical electronic equipment, medical materials manufacturing technology, artificial intelligence medical equipment standardization technology under centralized medical device of 3 units, further improve the medical devices standards organization system construction.

    Fourth, enhance the international discourse power of medical device standards

    Depth of participation and promote international medical device regulatory BBS (IMDRF) working group activities, in 2018, in IMDRF 13th management committee meeting, our country put forward the "update IMDRF members recognized international standard listing" project was agreed to by the new work, implements our country from participating in the leading international standard recognition rules of medical equipment a historic breakthrough.Leading to develop high performance the international standard of medical equipment, for the first time at the 2017 international surgical implants committee for standardization (ISO/TC150) annual meeting, the cardiovascular implants heart closure projects are proposed by the international standard, is China's first standard for medical devices industry into the ISO international standards, to promote our country medical instrument standard internationalization of pioneering significance, strongly promoted international discourse in the field of medical apparatus and instruments in China, promoted the standards in line with international standards in our country.


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