Interpretation of the New Medical Device Supervision and Management Regulations by Medical Glove Manufacturers

Interpretation of the New Regulations on the Supervision and Administration of Medical Devices to Strengthen Supervision

The safety and effectiveness of medical devices are directly related to human health and life safety. On the 31st, the newly revised "Regulations on the Supervision and Administration of Medical Devices" were promulgated, and relevant officials from the State Food and Drug Administration and the State Council Legislative Affairs Office interpreted the regulations.

Difference between leniency and strictness: High risk products are "pressured" while low-risk products are "loosened"

There are many types and spans of medical devices in China, ranging from tongue depressors and masks to various types of diagnostic and therapeutic equipment such as MRI instruments. The risks of various products vary greatly, including implantable devices that directly affect life safety and auxiliary devices that do not directly affect physical health.

These characteristics of medical devices determine that strict management must be implemented, but a 'one size fits all' approach cannot be taken. Wang Zhenjiang, Director of the Education, Science, Culture, and Health Department of the State Council's Legal Affairs Office, introduced that the current classification management system of medical device regulatory regulations is not perfect, and some measures do not reflect the differences in classification. The supervision of high-risk products is insufficient, and the supervision of some low-risk products that should be relaxed has not been relaxed, which puts a heavy burden on enterprises.

Wang Zhenjiang said that in response to this issue, the newly revised regulations clearly stipulate that medical devices should be classified and managed according to their level of risk. Medical devices should be classified into categories one, two, and three according to their level of risk, and the product classification list should be dynamically adjusted in a timely manner based on the production, operation, and use of medical devices. It is also required to fully listen to the opinions of all parties and refer to the practice of medical device classification when formulating the adjustment list. At the same time, the classification supervision measures have been improved, following the principle of distinguishing between leniency and strictness, to regulate high-risk products.

In terms of product management, it is specified that a type of medical device shall be subject to product filing management, the second type shall be subject to product registration management by the provincial food and drug regulatory department, and the third type shall be subject to product registration management by the General Administration. In terms of operation, the operation of a certain type of medical device has been opened up, without the need for permits or filing. Implement filing management for the operation of Class II medical devices and licensing management for the operation of Class III medical devices.

Whole process governance: strengthening "in-process" and "post event" supervision

Hu Yinglian from the School of Administration believes that the regulations have further simplified and delegated the approval process for the production and operation of medical devices. But with the reduction of pre-approval, it is particularly important to keep up with the supervision during and after the event.

In the past, there was a certain degree of 'heavy product approval and light process supervision' in the supervision of medical devices, "said Jiao Hong, Director of Food and Drug Safety at the State Administration for Market Regulation. In order to form a seamless supervision system throughout the entire process, the new regulations have unified the research and development, production, operation, and use of medical devices into the scope of supervision. Through standardized licensing, the establishment of medical device production quality management standards, re evaluation of registered medical devices, recall of medical devices, and strengthening the obligations of operating enterprises to inspect sales records and maintenance and use records of use units, a strict and full chain supervision system has been basically formed.

In the new regulations, a dedicated chapter on "Handling of Adverse Events and Recall of Medical Devices" is established, which clearly proposes the establishment of post market regulatory systems for monitoring, re evaluation, and recall of adverse events of medical devices. The monitoring, re evaluation, recall of adverse events of medical devices, as well as the quality management system, supervision and sampling of medical device production, operation, and use, have jointly formed a comprehensive post market supervision system that is in line with medical device supervision. This has formed a linkage between pre market and post market supervision, achieving supervision of the entire life cycle of medical devices.

Equal emphasis on rewards and punishments: encouraging scientific research and innovation, and severely punishing illegal behavior

At present, China's medical device industry still faces problems such as a relatively small overall scale and weak industrial foundation. Zhao Yixin, President of the China Medical Device Industry Association, frankly stated that the individual scale of medical device industry enterprises in China is relatively small. The output value of the 40 largest medical devices in the United States accounts for 20% of the global medical device industry output value, while China has about 16000 production enterprises, but their output value only accounts for about 5% of the global medical device industry. Some enterprises also engage in illegal and irregular behavior from time to time.

The General Provisions of the Regulation clearly state that it encourages research and innovation in medical devices, promotes the promotion and application of new technologies in medical devices, and drives the development of the medical device industry. The regulations also provide a series of specific institutional designs from the perspectives of optimizing review and approval, reducing the burden on enterprises, and encouraging innovation, providing strong legal basis and policy foundation for promoting the development of the medical device industry and encouraging enterprises to grow and strengthen.

To standardize industry behavior and promote the healthy development of the medical device industry, the new regulations not only encourage innovation, but also refine legal responsibilities, adjust punishment ranges, increase punishment types, and avoid enforcement gaps.

Mao Zhenbin, Director of the Inspection Bureau of the State Administration for Market Regulation, introduced that the original regulations generally impose fines of 2 to 5 times for serious violations, while the new regulations impose fines of 5 to 10 times, and even 10 to 20 times, significantly increasing the cost of illegal activities and significantly enhancing the deterrent effect. In the investigation and handling of illegal cases of forging, altering, buying, selling, renting, and lending medical device licenses, administrative penalties have been imposed on the perpetrators. However, for those who violate the Public Security Administration Punishment Law without constituting a crime, the new regulations clearly stipulate that the public security organs shall impose public security penalties, filling the gap between criminal and administrative penalties, leaving no opportunity for criminals to take advantage of, and strengthening the joint law enforcement efforts of departments.