China has passed New Medical Device Regulations which shall come into force from 1st June, 2021. It regulates the supervision and administration of medical devices.
The key features[1] are:
- The classification and administration of medical devices will be done by state on the basis of level of risk. The national compulsory standards for medical devices should be met by all the products.
- The regulation aims to ensure the safety and effectiveness of medical devices, to protect people’s health and safety, and to further develop the medical device industry.
- State will ensure that the supervision and administration will follow the principle of risk management, whole-course control, scientific supervision and shared governance by the whole society.
- Priority to be given to medical device innovation and encourage clinical applications to sustain high-quality development of the industry.
- The Regulation discusses an improved innovation system, support basic and application research of medical devices, and promote new technology. Enterprises are encouraged to cooperate with universities, scientific research institutions and medical institutions on studies and innovation. Medical device intellectual property copyrights will also be better protected.
- Medical device registrants should strengthen quality lifecycle management and be responsible for safety and effectiveness during the research, production and application process.
- The State will support and encourage medical institutions’ clinical trials.
- Medical device registrants and manufacturers should build quality management systems suited to specific medical devices and continue to improve efficiency. They should strictly follow required technology standards and ensure product quality.
- Online shopping platform operators should require real-name registration from medical device dealers. Their business license and product registration should be reviewed.
- Inspection and quarantine authorities will inspect imported medical devices according to law. The drug supervision and administration department under the State Council should notify the inspection and quarantine authorities about imported medical devices’ registration conditions.
- Advertisement of medical devices should be accurate and legitimate. The ads must be in compliance with registered instructions for use instead of containing false, exaggerated or misleading information. The ads should be censored by assigned provincial level authorities.
- The State should establish a system to monitor adverse events related to medical devices. The information network should be continuously improved. Professional inspectors should also be sent for more effective supervision.
*Tanvi Singh, Editorial Assistant has put this story together.
[1]http://english.www.gov.cn/policies/latestreleases/202103/19/content_WS60544e1dc6d0719374afb0e8.html