5 Things You Have to Know About the "New Regulations" on Medical Devices.
关于新《医疗器械监督管理条例》，你不得不知道的5件事！
The latest revised Regulations on the Supervision and Administration of Medical Devices (hereinafter referred to as the "New Regulations") have been officially implemented since June 1, 2021. They represent key changes of the legal management system in the field of medical devices. With this Q&A we would like to assist foreign-invested enterprises, especially those that have interest in doing business related to medical devices, to further understand China's regulatory policies.
最新修订《医疗器械监督管理条例》（以下简称“新《条例》”）作为医疗器械领域法律管理体系的基本规定，已自2021年6月1日起正式施行。为了能够让有志于从事医疗器械事业的外资企业对中国的监管政策有进一步的了解，我们就几个重要的值得关注的问题解答如下。
1.What is the biggest change in the New Regulations compared with former one?
新《条例》与旧法相比，最大的变化在哪里？
We think that the biggest change and highlight is that the New Regulations establish the system of Registrant or Record-filing Party of Medical Devices.
我们认为最大的变化和亮点就是新《条例》明确了医疗器械注册人、备案人制度。
The New Regulation simplemented this time is the second major revision since the Regulations on the Supervision and Administration of Medical Devices came into force on April 1, 2000, and remained implemented for more than 20 years. During this period, China's medical device supervision system has fundamentally changed. Since 2017, the Chinese government has carried out the pilot project of the Medical Device Registrant and Record-filing Party System (i.e. MAH system in the field of medical devices) in China (Shanghai) Pilot Free Trade Zone.
本次实施的新《条例》是自《医疗器械监督管理条例》2000年4月1日生效并实施20多年后的第二次重大修订，在此期间，中国的医疗器械监管体系从根本上发生了改变。2017年起，中国政府就在中国（上海）自由贸易试验区开展了医疗器械注册人、备案人制度（即医疗器械领域的MAH制度）的试点。
On July 7, 2020, the State Council of China issued the Notice by the State Council of Effectively Replicating and Promoting the Experience from the Sixth Round of Pilot Reforms in Pilot Free Trade Zones, making it clear that the pilot project of Medical Device Registrant and Record-filing Party System will be replicated and promoted throughout the country. According to the System, Medical Device Registrant and Record-filing Party cannot only produce products by themselves, but may also entrust enterprises with corresponding production conditions to produce medical device products. This was a major change to the previous management mode, which stated that Medical Device Registrant and Record-filing Party must have production lines, so as to realize the "unbinding" of medical device product registration and production license, thus bringing more opportunities to new market players looking forward to entering China's medical device industry.
此后的2020年7月7日，中国国务院发布了《关于做好自由贸易试验区第六批改革试点经验复制推广工作的通知》，明确将试点的医疗器械注册人、备案人制度在全国范围内复制推广。根据该制度，医疗器械注册人、备案人除自行生产产品外，还可委托具备相应生产条件的企业生产医疗器械产品。这改变了以往医疗器械注册人、备案人必须拥有生产线的管理模式，从而实现医疗器械产品注册和生产许可的“解绑”，给期待进入中国医疗器械行业的新的市场玩家带来更多的机会。
2.What changes have taken place in the provisions on illegal punishment under the New Regulations?
新《条例》下关于违法处罚的规定发生了什么变化？
The New Regulations have greatly increased the level of the punishment for illegal acts such as unlicensed production and operations, and the fine has increased from "more than 10 times and less than 20 times" of the value of goods to "more than 15 times and less than 30 times" of the value of goods.
新《条例》大大提高了无证生产经营等违法行为的处罚力度，罚金从货值金额的“10倍以上，20倍以下”提高至“15倍以上，30倍以下”。
At the same time, the principle of "Individual Liability" has been incorporated into the New Regulations. Indeed, the New Regulations stipulate that the legal representative, principal, person directly in charge and other liable persons of the entity that violates the law, can be directly punished at highest as follows: that the income obtained from the entity during the period of the illegal activity shall be confiscated, a fine of not less than 30%, but not more than three times of the income obtained, shall be imposed on them, and they shall be permanently prohibited from engaging in the production or operation of medical devices.
同时“处罚到人”的原则被纳入了新《条例》，即新《条例》规定，对违法单位的法定代表人、主要负责人、直接负责的主管人员和其他责任人员，最高可处没收违法行为发生期间自本单位所获收入，并处所获收入30%以上，3倍以下罚款，终身禁止其从事医疗器械生产经营活动。
In addition, where the overseas Medical Device Registrant and Record-filing Party of medical devices refuse to perform the decision on administrative penalty, they shall be banned from importing medical devices for ten years.
此外，若境外医疗器械注册人、备案人拒不履行行政处罚决定，也将被在10年内禁止其医疗器械进口。
3.What kind of optimization has the Chinese government made in the administrative examination and approval process of medical devices under the New Regulations?
新《条例》下中国政府对医疗器械的行政审批流程进行了什么样的优化？
In order to further promote the development of China's medical device industry, the New Regulations have optimized the approval procedures and materials for the product registration and filing, as well as manufacturing licensing and operating permit, which is mainly reflected in the following aspects:
为了进一步促进中国医疗器械行业的发展，新《条例》在产品注册、备案，以及生产、经营许可的审批程序和材料方面，都进行了优化，主要体现在以下几个方面：
①The product inspection report for the registration can be issued by the applicant for registration and record-filing party themselves.
注册检验报告可以都由注册申请人、备案人自行出具
The product inspection report in the product registration/record-filing materials is no longer limited to "Class I product (company can provide a self-inspection report); Class II and Class III product (company shall provide the inspection report issued by the entrusted qualified medical device inspection agency)". According to the New Regulations, when applying for registration/record-filing of all products (i.e. Class I, Class II and Class III medical device products), a self-inspection report of the medical device applicant for registration and record-filing party or an inspection report issued by the entrusted qualified medical device inspection agency can be provided. As a result, the process is more convenient for the applicants and record-filing party, and also reduces the corresponding cost.
产品注册/备案材料中的产品检验报告，不再限定为“一类产品可以提供自检报告；二类三类产品应提供有资质的医疗器械检验机构出具的检验报告”。新《条例》将其修改为所有产品（即第一类、第二类和第三类医疗器械产品）申请注册/备案时，均可提供医疗器械注册申请人、备案人的自检报告，或委托有资质的医疗器械检验机构出具的检验报告。这不仅为注册申请人、备案人提供了便利，也降低了相应的成本。
②Adding the situation, which can be exempted from clinical evaluation.
增加可以免于临床评价的情形
The clinical evaluation materials in the product registration/record-filing materials may be exempted from being submitted to the governement under any of the following circumstances: (1) the working mechanism is clear, design is finalized and production process is mature, the medical device of the same variety on the market has been applied in clinical practice for years with no record of a serious adverse event or the general-purpose is not changed; or (2) such medical device can be proven to be safe and effective through non-clinical evaluation. This greatly reduces the difficulty of application and the time limit of application for the applicant for registration and record-filing party of existing products.
产品注册/备案材料中的临床评价资料，只要符合“（一）工作机理明确、设计定型，生产工艺成熟，已上市的同品种医疗器械临床应用多年且无严重不良事件记录，不改变常规用途的；（二）其他通过非临床评价能够证明该医疗器械安全、有效的”情形之一的，可以免于提交。这对于既有产品的申请人、备案人来说大大降低了申请的难度和缩减了申请的时限。
③ Shorten the approval period of the manufacturing licensing and operating permit.
缩短生产许可、经营许可的审限
The approval period of the medical device manufacturing licensing and operating permit is shortened from 30 working days to 20 working days.
医疗器械生产许可和经营许可的审批期限均从30个工作日缩短为20个工作日。
④ An implicit approval system is implemented for the applications for the renewal of registration and clinical trials.
对延续注册、临床试验申请实行默示许可制度
Articles 22 and 27 of the New Regulations establish the implied approval system for the renewal of registration and clinical trials respectively, that is, if a decision has not been made within the specified time limit, it will be deemed as a permission granted. This is also conducive to urging the administrative authorities to make decisions in time and avoiding protracted situations.
新《条例》第22条和第27条分别确立了延续注册和临床试验的默示审批制，即超过规定的期限仍未作出决定的，将视为准予许可。这也有利于督促行政机构及时作出决定，避免出现久拖不决的情况。
4.What is the "Electronic ID Card" system for medical devices?
医疗器械“电子身份证”制度是指什么？
The"Electronic ID Card" system was formally incorporated into Article 38 of the New Regulation. According to the Announcement of National Medical Products Administration on Promulgation of the Rules on the Unique Identification System for Medical Devices, the medical devices sold and used within the territory of the People's Republic of China shall have attached to them the relevant codes. These codes composed of numbers, letters or symbols, must be featured on the products or packaging of the medical devices for the purpose of unique identification of the medical devices. Indeed, this is the description of the "Electronic ID Card" for medical devices.
新《条例》于第38条将“电子身份证”制度正式入法。根据国家药监局关于发布《医疗器械唯一标识系统规则》的公告，在中华人民共和国境内销售、使用的医疗器械，应当在医疗器械产品或者包装上附载，由数字、字母或者符号组成的代码，用于对医疗器械进行唯一性识别。这即是医疗器械“电子身份证”的含义和制度起源。
At present, according to the Notice of the State Food and Drug Administration on Matters Related to the Implementation of the First Batch of Unique Identification of Medical Devices and the Notice on Further Promoting the Pilot to Implement the First Batch of Unique Identification of Medical Devices, the implementation of the first batch of unique identification of medical devices has been fully started on January 1, 2021, with a total of 69 varieties in 9 categories included in the scope of implementation (including absorbable suture, contrast catheter and other surgical instruments, as well as implantable pacemakers, implantable nerve stimulators, hip prostheses, breast implants and other implant devices).
目前，根据《国家药监局关于做好第一批实施医疗器械唯一标识工作有关事项的通告》、《关于深入推进试点做好第一批实施医疗器械唯一标识工作的公告》，第一批医疗器械唯一标识实施工作已于2021年1月1日全面启动，纳入实施范围的共9大类69个品种，包括可吸收缝合线、造影导管等手术器械；还有植入式心脏起搏器、植入式神经刺激器、髋关节假体、乳房植入物等植入器械。
5.What are the incentives for innovation regarding medical devices in the New Regulations?
新《条例》对创新医疗器械有哪些鼓励措施？
New added Articles 8 and 9 of the New Regulations specify that China will formulate the industrial planning and policies for medical devices at the state level, and make the innovation in the field of medical devices the focus of development, giving priority to the evaluation and approval of innovative medical devices, supporting the clinical popularization and use of innovative medical devices, and promoting the high-quality development of the medical device industry. At the same time, China also will improve the innovation system for medical devices at the state level and support the basic research and applied research of medical devices, promote the popularization and application of new technologies for medical devices, and give support in respect of scientific and technological project initiation, financing, credit, procurement by public bidding, medical insurance, etc. Enterprises are supported to establish or jointly establish R&D institutions. Enterprises are encouraged to cooperate with institutions of higher learning, scientific research institutes and medical institutions to carry out the research and innovation, as well as strengthen the protection of intellectual property rights of medical devices.
新《条例》新增第八条和第九条，明确中国政府将在国家层面制定医疗器械产业规划和政策，将医疗器械创新纳入发展重点，对创新医疗器械予以优先审评审批，支持创新医疗器械临床推广和使用，推动医疗器械产业高质量发展。同时，中国也将在国家层面完善医疗器械创新体系，支持医疗器械的基础研究和应用研究，促进医疗器械新技术的推广和应用，在科技立项、融资、信贷、招标采购、医疗保险等方面予以支持。支持企业设立或者联合组建研制机构，鼓励企业与高等学校、科研院所、医疗机构等合作开展医疗器械的研究与创新，加强医疗器械知识产权保护等。
The New Regulations also provide new opportunities for the overseas medical innovation companies. Namely in the past, only overseas-launched medical devices could be registered/record-filed in China. However, according to Articles 15 and 16 of the New Regulations, innovative medical devices that are not launched on the overseas market, with the supporting documents proving that such medical devices are approved to be marketed by the competent authority of the country (region) where the record-filing party is located, may be submitted. This means that in the future, innovative medical devices may be launched simultaneously in the overseas and Chinese markets, and even global products may be launched first in China.
而对于境外医疗创新公司而言，新《条例》也提供了一个全新的机遇。即：过去只有在中国境外上市的医疗器械才可以在中国境内注册/备案，而根据新《条例》第十五条和第十六条的规定，未在境内外上市的创新医疗器械，可不提交注册/备案申请人所在国（地区）主管部门准许该医疗器械上市销售的证明文件。这意味着今后创新医疗器械将可以在境内外同步上市，甚至将会有全球性的产品在中国首先上市。
After a brief interpretation of the New Regulations, we are full of confidence in the future of China's medical device industry. At present, various measures supporting the New Regulations are also soliciting public opinions. We believe that the implementation of the New Regulations and various supporting measures will also bring more opportunities to Israeli companies with high innovation ability in the field of medical devices. Thus, we look forward to seeing more Israeli innovative companies being highly successful in the Chinese market in the future.
在对新《条例》进行一个简单解读后，我们对中国医疗器械行业的未来充满了信心。目前与新《条例》相配套的各项措施也在征求公众意见中。我们相信随着新《条例》和各项配套措施的落实，也会给在医疗器械领域具有较高创新能力的以色列公司带来更多的机遇，期待今后能够在中国市场看到更多的以色列创新公司在中国取得成功。
This article is written by IsCham member - A&Z Law Firm. For any further questions or inquiries concerning the issues raised in this article, you are welcome to contact Andrew Zhang at azhang@a-zlf.com.cn.
本文由商会会员上海里格律师事务所供稿。若对文章中涉及内容有疑问，欢迎通过电子邮箱：azhang@a-zlf.com.cn联系Andrew Zhang。