Regulation on Supervision and Administration of Medical Devices (2021 Revision)
ISSUING AUTHORITY:
State Council
DATE OF ISSUANCE:
February 9, 2021
EFFECTIVE DATE:
June 1, 2021
On February 9, 2021, the State Council promulgated the Regulation on the Supervision and Administration of Medical Devices (2021 Revision) (“Regulation”), which revised and adopted at the 119th executive meeting of the State Council on December 21, 2020, will take effect on June 1, 2021.
The quality and standards of medical devices have been improving amid the fast development of China's pharmaceutical industry in recent years. It is necessary to establish a more scientific and efficient evaluation and approval system for medical devices. The aim of this Regulation is to strengthen the responsibility of enterprises, clearly define the medical device recording and registration approval procedures, beefing up regulatory tools, additional regulations and supervision measures on medical device unique identification traceability and extension inspection.
The Regulation introduces a category-based administration of medical devices according to the level of risk. All products should satisfy the national compulsory standards for medical devices. Medical device registrants should strengthen quality lifecycle management and be responsible for safety and effectiveness during the research, production, and application process. The quality management systems should be built by medical device registrants and manufacturers to suit specific medical devices and to improve efficiency. They should strictly follow the required technical standards and ensure product quality to comply with the Regulation.
To further reduce the burden on enterprises and encourage innovation, the Regulation establishes a fast-track approval pathway for innovative medical devices, promotes the information construction of review and approval of medical device and optimizes the approval and filing procedures.
In terms of legal liability, the Regulation shows that severe punishment shall be meted out to companies and persons responsible for serious violations of the law, such as revocation of their licenses, prohibition of entry into trades and markets, and criminal responsibility shall be investigated in accordance with the law if any crime is involved.
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