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The Essence of Newly Revised “Regulations on the Supervision and Administration of Medical Devices”

from CIRS by
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. It has played an important role in ensuring the quality and safety of medical devices and promoting the healthy development of the industry.
On 17th of March , the newly revised "Regulations on the Supervision and Administration of Medical Devices" was officially released and will be implemented on 1st of June, 2021. The new regulations have a total of 107 articles, including 8 chapters including general provisions, product registration and filing, production, operation and use, handling and recall of adverse events, supervision and inspection, legal responsibilities and supplementary provisions.
The general idea of this revision of the regulations:
1. Implement the reform requirements of the drug and medical device review and approval system, and consolidate the main responsibility of the enterprise.
2. Consolidate the achievements of the reform of “delegating control, delegating control to service”, and unleash market innovation activity.
3. Strengthen the supervision of the whole life cycle and whole process of medical devices, and improve the supervision efficiency.
4. Increase the penalties for violations and increase the cost of violations.
The main content of the new regulations:

1. Implement the system of registrant and recorder and strengthen the main responsibility of the enterprise

  • It is stipulated that the enterprises and research institutions that obtain the medical device registration certificate or handle the medical device filing shall be the registrant and filing person, and shall be responsible for the safety and effectiveness of the entire process of medical device development, production, operation, and use according to law.
  • Clarify the obligations of the registrant and the recorder, stipulate that the registrant and the recorder shall establish and effectively operate a quality management system, conduct post-marketing research and risk management, monitoring and re-evaluation of bad time, and establish and implement product traceability and recall systems.
  • Clarify the rights and responsibilities of registrants, record holders, and other market entities, and clarify the obligations of entrusted production enterprises, e-commerce platform operators, users and other entities.

2. Implement reform measures and encourage innovation and development of the industry

  • Bring medical device innovation into the focus of development, improve the medical device innovation system, and improve independent innovation capabilities.
  • Optimize approval procedures, simplify approval materials, implement implied licenses for renewal of registration and clinical trials, and shorten the period of production and operation license review.
  • Optimize the filing procedures, reduce filing items, and implement informative filing.

3. Improving the supervision system and improving supervision efficiency

  • Strengthen the construction of supervisory teams and establish a professional and professional inspector system.
  • Enriching supervision methods, adding supervision measures such as product unique identification traceability, extended inspection, and punishment for dishonesty.
  • Further clarify the division of responsibilities between the drug supervision and management department and the health authority, and strengthen the supervision and inspection of the use of medical devices.
  • Strengthen accountability, and increase the system of interviews with key persons in charge of departments and local governments that have not performed their duties in accordance with the law.

4. Intensify punishment and increase the cost of violations

  • To implement the requirement of "punishing the person", the relevant responsible personnel of the unit that seriously violated the law will confiscate the income from the unit during the period of the violation, and may also impose a fine of up to 3 times, and prohibit them from engaging in related activities for 5 years to life.
  • Increasing the penalties for prohibiting entry into the industry and the market, and depending on the circumstances of the violation, impose penalties such as revocation of licenses and prohibition of relevant activities for a certain period of time on violations; if overseas registrants and filing persons refuse to perform administrative punishment decisions, their medical treatment shall be prohibited within 10 years Import of equipment.
  • Significantly increase the fines, and for serious violations involving quality and safety, a fine of up to 30 times the value of the goods can be imposed.

In addition, combined with the practice of prevention and control of new coronary pneumonia, in order to further improve the ability to respond to particularly major public health emergencies, the emergency use system of medical devices has been added, and it is possible to stipulate that there are particularly major public health emergencies or other emergency times that seriously threaten public health. Emergency use of medical devices within a certain range and time limit.

The official link of "Regulations on the Supervision and Administration of Medical Devices":


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