Looking back to the "Twelfth Five Year plan"

Evolution of policy and regulations

In April 1, 2000, the promulgation and implementation of the regulations on the supervision and administration of medical devices (hereinafter referred to as the "Regulations") not only opened up the big screen, but also laid the foundation of the supervision system for medical devices. On this premise, China has issued a corresponding supporting regulations and normative documents, in accordance with the requirements of the full life cycle of medical equipment products, began to explore and build China's medical device regulatory system.

However, limited by regulatory capacity and experience, the initial stage of China's medical equipment supervision and control is not fully covered the entire life cycle of medical devices. The system design of the original "Regulations", the approval of medical devices before the approval of the approval, and the risk management of the listing after the lack of thinking. Such as the former State Food and Drug Administration (SFDA) released the medical device classification rules, the medical device production and supervision management approach and the medical device registration management approach and other departments, and the focus on the medical device before the review and approval to make the appropriate. These legislative work reflects the importance of the supervision of medical device safety source management, in a specific historical stage played a good role. However, with the deepening of the medical device safety supervision, in particular, the need to strengthen the risk management after the listing, medical equipment supervision slowly by the approval of the listing of products before and after a single big development to the listing and the situation after the listing supervision.

In 2008, the management department issued a "medical device adverse event monitoring and re evaluation management approach", the medical device after the listing of the risk management system to make the system arrangement. In 2011, China began to implement the "medical device recall management approach", which has begun to the end of the life cycle of medical equipment products to make a systematic exploration. It is worth mentioning that, in June 2014 the implementation of the new version of the medical equipment supervision and management regulations (hereinafter referred to as the new regulations) on the medical device adverse event handling and medical device recall a separate chapter, the first time from the administrative regulations to establish a comprehensive risk management system for medical devices. As a result, the new model of the whole process of medical devices is formally established, which highlights the historic progress.

"Process management" has been repeatedly mentioned

In the path of the evolution of medical devices regulations, the term "process management" has been repeatedly mentioned. The connotation of the word is mainly in two aspects: first, the supervision department of medical equipment product life cycle of external administrative supervision, the corresponding is the main responsibility of the regulatory body; two is related to the medical device product life cycle of internal quality management, corresponding to the main responsibility of the enterprise.

Since the implementation of the regulations, the regulatory authorities to actively build a system, investigate and punish illegal behavior to maintain the normal order of the industry, according to the requirements of medical equipment product life cycle, the medical device development, classification, testing, clinical evaluation, registration, production, management, use, adverse event monitoring and re evaluation and recall and all aspects of administrative legislation, is the embodiment of regulatory authorities in the process to fulfill regulatory responsibilities. To guide and urge enterprises to fulfill their main responsibility, our country issued the "medical instrument production quality management standard" and "management of medical equipment quality management" and other process management of normative documents, require enterprises to establish the main responsibility consciousness, actively fulfill the production, the business process of quality management obligations. This also shows that in the construction of food and drug safety in the pattern of social governance, medical equipment, process management, especially the main responsibility of the enterprise management process will be the main direction of the development of regulatory policies and regulations.

"Strict liability" is a high frequency word

In addition to the full supervision and process management, the strict liability is also the development trend of the regulatory policy of high frequency words. In the "the most stringent standards, the most stringent regulation, the most severe punishment, the most serious accountability" and "the four most" under the background of severe degree of medical liability comprehensive upgrade from the new "Regulations" the relevant provisions of the liability of the illegal content can be a comprehensive picture. The supervision and inspection, flight inspection, inspection, quality announcement, risk monitoring, responsibility interviews, the "black list" and other means is more like a "combined", in the lawbreakers confused and disoriented at the same time, the development of the industry environment has been cleared.

Outlook 45"

Perfect law system is a top priority

Thirteen five period, the new system implementation by the new "Regulations" of the spring to improve the medical device regulatory authorities will be a pressing matter of the moment.

According to the provisions of the new regulations, the practice of medical devices full supervision mode is also required to improve the supporting regulations and regulatory documents as a support, and the current regulatory system can not meet this requirement. Such as medical devices use the relevant regulations have not been announced, after the listing of adverse events monitoring and re evaluation of the management is also facing changes. At the same time, according to the needs of process management, the two major aspects of quality management in the production and management practices, but also need to continue to publish the implementation of the medical device clinical trial quality management standards, the use of medical equipment quality management standards, in order to better implement the main responsibility of medical devices related businesses and their use.

回望“十二五”

政策法规演变

　　2000年4月1日，《医疗器械监督管理条例》(下称原《条例》)的颁布实施不仅掀开了我国医疗器械依法监管的大幕，而且奠定了医疗器械各项监管制度的基础。以此为前提，我国陆续发布了相应的配套规章及规范性文件，按照医疗器械产品全生命周期监管的要求，开始摸索构建中国医疗器械监管法规体系。

　　但是，受监管能力及经验不足的限制，起步阶段的中国医疗器械监管并没有完全覆盖整个医疗器械全生命周期。原《条例》下的制度设计，对医疗器械上市前的审批重视有余，而对上市后的风险管理思考不足。如原国家食品药品监督管理局(SFDA)发布了《医疗器械分类规则》、《医疗器械生产监督管理办法》和《医疗器械注册管理办法》等部门规章，侧重对医疗器械上市前的审评审批做出相应规定。这些立法工作反映了重视医疗器械安全源头管理的监管思路，在特定的历史阶段发挥了较好的作用。但是，随着对医疗器械安全监管认识的深化，特别是加强了上市后风险管理必要性的认识，医疗器械监管慢慢地由上市前产品审批一枝独大发展到上市前和上市后监管并重的局面。

　　2008年，管理部门发布了《医疗器械不良事件监测和再评价管理办法》，对医疗器械上市后监管阶段的风险管理做出了制度安排。2011年，我国开始实施《医疗器械召回管理办法》，说明已经开始对医疗器械产品全生命周期的末端管理作出制度化的探索。值得一提的是，2014年6月实施生效的新版《医疗器械监督管理条例》(下称新《条例》)对医疗器械不良事件处理和医疗器械召回单列一章，第一次从行政法规的层面全面确立了医疗器械上市后监管阶段的风险管理制度。由此，医疗器械全程监管的新模式得以正式确立，凸显了历史性的进步。

“过程管理”屡被提及

　　在医疗器械法规政策演变的路径中，“过程管理”一词屡被提及。该词的内涵主要有两方面：一是监管部门对医疗器械产品全生命周期的外部行政监管，对应的是其监管主体责任;二是相关企业对医疗器械产品全生命周期的内部质量管理，对应的是其企业主体责任。

　　原《条例》实施以来，监管部门积极建章立制，查处违法行为维持行业正常秩序，按照医疗器械产品全生命周期的要求，对医疗器械研发、分类、检验检测、临床评价、注册、生产、经营、使用、不良事件监测和再评价以及召回等所有环节进行行政立法活动，正是监管部门在“过程管理”中履行监管主体责任的体现。为了引导、督促企业履行其主体责任，我国发布了《医疗器械生产质量管理规范》和《医疗器械经营质量管理规范》等过程性管理的规范性文件，要求企业树立主体责任意识，积极履行生产、经营过程中的质量管理义务。这也表明在构建食品药品安全社会共治格局的大背景下，医疗器械“过程管理”尤其是企业主体责任下的“过程管理”将是监管法规政策发展的主要方向。

“严格责任”是高频词

　　除“全程监管”和“过程管理”外，“严格责任”也是法规政策发展动向的高频词。在中央提出“最严谨的标准、最严格的监管、最严厉的处罚、最严肃的问责”等“四个最严”的背景下，医疗器械法律责任的严厉程度全面升级，这从新《条例》有关违法责任的规定内容即可一窥全豹。随之而来的监督检查、飞行检查、抽查检验、质量公告、风险监测、责任约谈、“黑名单”等措施和手段更似一套“组合拳”，在使违法分子晕头转向的同时，行业发展的环境也得到了清理。

展望“十三五”

完善法规体系是当务之急

　　“十三五”期间，乘新《条例》实施的春风完善医疗器械监管法规新体系将是监管部门的当务之急。

　　根据新《条例》的规定，医疗器械全程监管模式的实践还需要完善的配套规章以及规范性文件作为支撑，而当前的法规体系还不能满足这一要求。如医疗器械使用环节相应的规章尚未公布，上市后的不良事件监测和再评价管理依据也面临修改。同时，根据“过程管理”的需要，在上述生产和经营两大环节质量管理规范实施的基础上，还需要继续发布实施《医疗器械临床试验质量管理规范》、《医疗器械使用质量管理规范》，以便更好地落实医疗器械相关企业及其使用单位的主体责任。另外，为了给医疗器械监管提供强大的技术支撑，还需要修订《医疗器械标准管理办法》，实施《医疗器械临床试验机构资质认定管理办法》和《医疗器械检验机构资质认定管理办法》，推动医疗器械临床试验机构和医疗器械检验机构这两大技术评价系统的发展，打造能够满足行业发展需求的医疗器械监管技术支撑机构联合体。

严格落实监管制度

　　除了努力完善医疗器械监管法规新体系外，监管部门更重要的工作是严格落实新法规体系下的监管制度。这些任务中，以改革医疗器械审评审批制度、创新医疗器械特别审批、优化临床评价和监管信息化等几项工作尤为紧迫。

国家把高性能医疗器械作为“中国制造2025”优先发展的十大领域之一，需要在法规政策上形成行业产业发展的合力。医疗器械的审评审批、创新医疗器械的认定、临床评价路径的优化以及互联网+背景下的监管信息化，都与医疗器械产业的更新换代密切相关。另外，还要解决3D打印医疗器械带来的监管难题。因此，上述几个方面也将是今后五年内监管工作的重点。另外，不容忽视的是，要完成这些艰巨的任务，监管队伍的自身建设也是“十三五”期间需要下足功夫去面对的重中之重，否则一切将无从谈起。

给企业带来的影响

　　法规政策的演变给行业企业带来了严重挑战。医疗器械全程监管和过程管理的推行，让一些条件不健全的企业产生了相当大的压力。医疗器械法规体系的完善，表明行业正逐步得到规范，竞争有序的行业环境正在树立。就医疗器械全程监管和过程管理两者的要求而言，与其说是企业相关义务的加大，还不如说是企业主体责任的回归。因为企业不能只以赚取利润为己任，而把产品的相关风险甩给政府和社会。一个对社会负责任的企业，必将主动承担起自己质量管理的份内之责。

　　在未来相当长的时间内，有效促使相关企业履行其主体责任将成为监管部门的重要工作之一，严格的执法与管理也将是未来的新常态。相关医疗器械企业、使用单位除了主动融入行业发展潮流、积极履行企业义务、狠抓产品质量之外别无他途。在中央“四个最严”的指导精神下，与生命和健康紧密联系的医疗器械行业也只能在“严”中求生存，在“严”中求发展。(本文作者为上海健康医学院副教授、CFDA高级研修学院特聘专家)