Health & Beauty

According to the relevant person in charge of the State Drug Administration, the revision of the new regulations reflects the three characteristics of "lenient advancement, strict control, and heavy punishment".

On the 1st, the newly revised "Regulations on the Supervision and Administration of Medical Devices" was formally implemented. The new regulations provide unprecedented levels of detail, strict supervision, and severe penalties on the production, operation and use of medical devices. In the future, the registrant must bear legal responsibility for the quality of the product's entire life cycle, and each medical device will have a unique "electronic ID card" for traceability management. Many business leaders in the industry said that providing products with high quality throughout the life cycle is the only way for a company to survive.

The "Regulations on the Supervision and Administration of Medical Devices" were formulated in 2000, and were fully revised and partially revised in 2014 and 2017. On December 21, 2020, the 119th executive meeting of the State Council reviewed and approved the new regulations. The new regulations have 8 chapters and 107 articles.

According to the relevant person in charge of the State Drug Administration, the revision of the new regulations reflects the three characteristics of "lenient advancement, strict control, and heavy punishment".

——"Wide advancement", encourage innovation, and promote the high-quality development of the industry. In terms of specific system and measures, the regulations implement the reform requirements of "delegation of control and service", optimize registration procedures, improve registration efficiency, implement informative filing, scientifically set clinical evaluation requirements, allow for the development of extended clinical trials, encourage medical institutions to conduct clinical trials, and strengthen Medical device supervision and management informatization construction. For example, the notification filing is implemented for low-risk medical devices, and the filing is completed after the filing party submits the materials that meet the requirements, which reduces the filing burden of the enterprise and improves efficiency.

—— "Strict management" to promote the modernization of the regulatory system and regulatory capabilities. For example, it is stipulated that the unique identification system for medical devices shall be implemented step by step, and “electronic ID cards” shall be assigned to medical devices, so as to realize the transparency and visualization of production, operation and use, and improve the traceability of products. The establishment of a unique identification system can strengthen the supervision of the entire life cycle of medical devices, and can also build medical device supervision big data, so that the source of medical devices can be traced, whereabouts can be traced, and responsibilities can be investigated, and smart supervision can be realized.

-"Heavy punishments" to severely punish illegal acts. For violations related to quality and safety, the penalties have been greatly increased, and fines up to 30 times the value of the goods can be imposed; the penalties for prohibiting entry into the industry and the market have been increased, and the offenders shall be revoked according to the circumstances of the law, and the offender shall be prohibited from engaging in a certain period Penalties for related activities and non-acceptance of related license applications; add "punishment to person" measures, and impose penalties such as confiscation of income, fines, and prohibition of related activities for 5 years to life on relevant responsible personnel of units that seriously violate the law.

"The most important content of the new regulations is the establishment of a medical device registrant system." Hu Huihui, deputy secretary general of the China Medical Device Association, said that the registrant system refers to the application of medical device registration applicants, whose samples are entrusted to the trustee to produce and obtain the "Medical Device After the registration certificate, the registrant becomes the registrant; the registrant entrusts the trustee to produce the products and market them in the name of the registrant, and assumes the corresponding legal responsibility for the product quality of the medical device throughout the life cycle.

She told reporters that the medical device registrant system is a modern medical device management system widely adopted internationally, and it is also one of the core systems for the revision of the new "Regulations." The core essence of the system is to encourage producers and licensees to separate, to open up commissioned production, and to open factories in different places, which is conducive to optimizing resource allocation, promoting industrial concentration, enhancing competitiveness, and mobilizing the enthusiasm of research and development institutions to reduce repeated investment , Reduce the cost of product listing.

In addition, the new regulations put "innovation" at a key position. For example, it is required that “units and individuals that have made outstanding contributions to the research and innovation of medical devices shall be commended and rewarded in accordance with relevant national regulations.”

The new regulations also emphasize: the state formulates medical device industry plans and policies, incorporates medical device innovation into the development focus, prioritizes innovative medical devices for review and approval, supports the clinical promotion and use of innovative medical devices, and promotes the high-quality development of the medical device industry.

"The many policies that encourage innovation in the new regulations give companies a lot of motivation to develop new products, and actively try to import innovative products on the market in China and major countries around the world, so as to bring the gospel to patients as soon as possible." Johnson & Johnson (Shanghai) Medical Equipment Co., Ltd. Guo Ye, the head of the company's regulatory affairs department, said that he admires the forward-looking and professional nature of device supervision of the State Food and Drug Administration. Many concepts are highly in line with international standards, and he has led the way to put forward the best experience in supervision.