[Commentary] On March 26, the State Council Information Office held a briefing to introduce the newly revised "Regulations on the Supervision and Administration of Medical Devices".

According to Changjiang Deyuan, the Department of Medical Device Registration Management of the National Medical Products Administration, the new "Regulations" have added and improved the conditional approval system, and medical devices that are urgently needed for public health events can be approved with conditions.

　[Concurrent] Changjiang Deyuan, Department of Medical Device Registration Management, National Medical Products Administration

　In order to meet the needs of responding to major public health emergencies and expedite the use of emergency medical devices, the new "Regulations" system summarizes the experience of epidemic prevention and control, and adds and improves the following systems: First, the priority review and approval system, and innovation Medical devices are subject to priority review and approval.

The second is the conditional approval system.

Medical devices urgently needed in response to public health events may be approved with conditions on the basis of a comprehensive balance of benefits and risks.

The third is the emergency use system. In the event of a particularly major public health emergency or other emergency that seriously threatens public health, medical devices can be used urgently within a certain range and time limit.

In addition, the new "Regulations" also added a special approval import system for clinical urgent needs.

　[Explanation] Wang Zhenjiang, director of the Legislative Third Bureau of the Ministry of Justice, said that increasing the cost of violations and severely punishing violations are also one of the key concerns in the revision process.

He stated that the new "Regulations" increase the penalties for illegal activities involving medical devices in accordance with the "four strictest" requirements, further protect the health of the people, and create a level playing field for law-abiding companies.

　[Concurrent] Wang Zhenjiang, Director of the Third Legislative Bureau of the Ministry of Justice

　One is to increase penalties for violations involving quality and safety, and fines up to 30 times the value of the goods can be imposed.

The second is to intensify the penalties for prohibiting entry into the industry and the market, and depending on the circumstances of the violation, penalties such as revocation of licenses, prohibition of related activities for a certain period of time, and non-acceptance of related license applications, etc., will be imposed on offenders depending on the circumstances of the violation.

The third is to increase the "punishment to the individual" measures, and impose penalties such as confiscation of income, fines, and prohibition of relevant activities for five years to lifelong on the relevant responsible personnel of units that seriously violate the law.

　[Explanation] It is understood that 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" will come into effect on June 1, 2021.

　(Reporting by reporter Shan Lu from Beijing)

Editor in charge: [Li Yuxin]