What Kind Of Dividends Will Be Brought By The Implementation Of The New Medical Device Regulatory Regulations?

China's medical device supervision has entered a new era.

Since June 1, the newly revised regulations on the supervision and administration of medical devices (hereinafter referred to as the "new regulations") have been formally implemented. For the first time, the new regulations put "ensuring the safety and effectiveness of medical devices, ensuring human health and life safety" and "promoting the development of medical device industry" at the same position, focusing on patients, strengthening the risk management of enterprise life cycle, and highlighting the importance of promoting the innovation and development of medical device industry.

This time, the new "Regulations" have added the registration and filing system of medical devices, the conditional approval system of medical devices, the emergency use system of medical devices, the management system of expanded clinical trials of medical devices, the unique identification system of medical devices, and the network sales management system of medical devices.

In terms of specific contents, such as the cancellation of registration inspection in the new regulations, not only speeds up the process of product listing, but also strengthens the main responsibility of enterprises as the first responsible person; Encouraging medical institutions to carry out clinical trials of innovative medical devices is conducive to accelerating the progress of clinical trials of innovative medical devices and listing on the market; The new customized device regulations are helpful for the combination of medicine and industry to develop more ideal devices; Special examination and approval ways, such as conditional, emergency, rare disease priority, etc.

In addition, the new regulations have further strengthened supervision, including strengthening the responsibility of enterprises and research institutions for the safety and effectiveness of medical devices, increasing the punishment for illegal acts, increasing the amount of fines for serious violations involving quality and safety, and imposing severe penalties on units and persons responsible for serious violations such as revoking their licenses and banning entry into the industry and market, If a crime is involved, criminal responsibility shall be investigated according to law.

In this regard, a researcher on market access of multinational medical device enterprises said in an interview with 21st century economic report that this is the third revision of the regulations since the promulgation of the regulations in 2000. Generally speaking, the new regulations have positive significance for the industry, and the reform direction is lenient and strict control, which has strengthened a number of new policies issued in recent years.

Among them, it is worth noting that the medical device registrant system is a modern medical device management system widely adopted by the international community, and is also one of the core systems of this revision. The core meaning of the system is: the medical device registrant is the "producer" of medical device products, and it has a great impact on the safety of medical devices in the whole process of research, production, operation and use The validity shall be responsible according to law.

The new regulations summarized the pilot experience in recent years, further clarified the core content of medical device registration system, and revised the basic positioning, production, operation and adverse event detection.

The full implementation of the registrant system will bring huge dividends to the industry

According to the State Food and drug administration, the system of medical device registrants and recorders is the basic system throughout the whole life cycle of medical devices, and it is also an important measure for China to thoroughly implement the reform of medical device review and approval system.

On May 31, the State Food and Drug Administration announced that the system of medical device registrants and recorders will be fully implemented. From June 1, 2021, all enterprises and medical device development institutions that hold the medical device registration certificate or have gone through the first class medical device filing shall perform the obligations of the medical device registrant and the filing person according to the new regulations, We should strengthen the quality management of the whole life cycle of medical devices, and be responsible for the safety and effectiveness of medical devices in the whole process of development, production, operation and use.

It is understood that the implementation of the filing system for class I medical devices has solved the legal bottleneck that the first class medical devices were not included in the pilot work of the medical device registration system.

At the same time, the new regulations stipulate that class I medical devices can be produced by themselves or commissioned. The record holder of the entrusted production of medical devices shall be responsible for the quality of the entrusted medical devices, strengthen the management of the production behaviors of the entrusted production enterprises, and ensure that they produce according to the legal requirements.

The general manager of a medical device enterprise in Jiangsu Province told the reporter of the 21st century economic report that before the promulgation of the new regulations, to a certain extent, the supervision of the recorders of class I medical devices was more strict than that of the second and third categories. Only if the consignor of the first class of medical devices has the production capacity and production qualification, can it entrust other enterprises to produce, thus causing contradictions, It is only suitable for some enterprises to expand production capacity.

The relevant responsible person of Hangzhou market supervision and Administration Bureau once wrote a public article, pointing out that the new regulations allow a class of medical devices to implement the filing system, which will be conducive to R & D institutions, medical institutions, etc. as the main body of filing to hold products and promote the technical improvement of new products. Under the system of commissioned production, the mode of commissioned production is conducive to promoting the standardization and scale of the production of the first kind of medical devices.

In fact, it is not only a kind of device, but also has great significance for the whole industry. Since 2018, the State Food and drug administration has launched the pilot work of medical device registration system, with the pilot scope reaching 22 provinces, autonomous regions and municipalities directly under the central government. As of March this year, a total of 1054 products have been approved for listing in accordance with the medical device registration system.

Yu Qingming, Secretary of the Party committee of Sinopharm Holding Co., Ltd., once said that the medical device registration system will bring huge dividends in three aspects: first, it will help optimize resource allocation, promote industrial concentration and enhance competitiveness; Second, it is conducive to encourage innovation and shorten the product listing cycle; Third, it is conducive to promoting supply side structural reform and eliminating "low, small and scattered".

In terms of optimizing resource allocation, Yu Qingming analyzed in detail that some enterprises have several branches located in different provinces. At present, they can only do their own work and organize development and production respectively, which is a waste of resources and inconvenient for management. After the implementation of the medical device registration system, enterprises can combine human resources, land prices, environmental protection requirements, labor costs, transportation costs and other elements to coordinate the industrial layout of R & D, production and sales, and optimize the allocation of group resources, which will greatly increase the autonomy and competitiveness of enterprises.

Enterprises may have concerns about commissioned production

According to the 21st century economic report, local R & D and production is a trend and has been clearly encouraged in various regions. After the comprehensive promotion of medical device registration system, it is equivalent to providing a new mode to help foreign-funded enterprises to realize localization production.

It is understood that in the past, the supply of foreign-funded enterprises included the direct import of finished products from abroad (which may still be the mainstream now) and the investment and establishment of factories in China for production. In the future, there will be more ways of commissioned production.

"If raw materials and parts can be obtained from China, commissioned production will be more economical than investment production, which can help enterprises reduce investment in fixed assets and shorten the lengthy global decision-making process brought about by opening factories." The researchers said.

However, the implementation of any new system has both advantages and disadvantages. As the medical device registration system is still in the trial stage, it may face more challenges in the future. From the perspective of different subjects, the main risks may include: the registered person's ability to bear quality responsibility and life cycle risk management ability is insufficient, the protection of intellectual property rights is difficult to balance with the commissioned production, the entrusted production enterprises are not in place to implement the production responsibility, and the supervision departments increase the difficulty of cross regional entrusted production supervision.

The above-mentioned researchers also said that the new regulations pointed out that the registrant should be responsible for the safety and effectiveness of products throughout the whole process, but entrusting other enterprises to produce may reduce the registrant's control over the whole process of product production and circulation. Foreign funded enterprises generally have strict compliance management, which may cause enterprises to have certain concerns about commissioned production.

Researchers related to pharmaceutical regulations and policies of China Pharmaceutical University also pointed out that the biggest highlight of the implementation of the registrant system lies in the removal of part of the requirements for the entrusted party, greatly reducing the access threshold of the entrusted production enterprises, but at the same time, there is also the risk that the entrusted enterprises can not fulfill their production responsibilities.

Specifically, due to the fact that the entrusted enterprise is not the subject of responsibility and only undertakes part of the product quality and safety responsibility, it may not pay enough attention to product quality management; If the entrusted party accepts the entrustment of more than one registrant at the same time, how to reasonably arrange the production plan of different entrusted source products and different entrusted varieties according to the actual production capacity will also become the difficulty.

In fact, the risk point of product quality does not only lie in the entrusted party. There is a view in the industry that under the system of medical device registrant, the industry realizes the mode of separation of production and research. However, most of the registered people have strong R & D attributes, and there are many shortcomings, such as insufficient laws and regulations, insufficient quality management system, and weak awareness of product traceability, These may lead to hidden dangers for the quality of the commissioned products in the future, and also bring great challenges to the entrusted party.

However, since the promulgation of the new ordinance, it has been widely concerned by the industry and full of expectations. In particular, under the incentive and guarantee of the new regulations, it helps to promote medical device enterprises in China to strengthen basic research and applied research, promote the construction of innovation system and innovation ability, further strengthen the key core technology research, strive to break through the bottleneck of technology and key raw materials, make up for the shortcomings of China's high-end medical devices, and benefit more patients.

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