Core Legal Basis
The prohibitive provisions on the non-reuse of single-use medical devices are mainly set out in two documents: first, the Regulations on the Supervision and Administration of Medical Devices (State Council Order No. 739, effective June 1, 2021); and second, the Measures for the Supervision and Administration of Single-Use Sterile Medical Devices (National Medical Products Administration Order No. 24, promulgated and effective in October 2000).
Core Provisions of the Regulations
The Regulations on the Supervision and Administration of Medical Devices expressly provide that single-use medical devices must not be reused, and that used ones shall be destroyed in accordance with relevant state regulations and that the destruction shall be recorded. The catalogue of single-use medical devices is formulated, adjusted and published by the drug regulatory department of the State Council in conjunction with the health authority of the State Council.
Catalogue Management and Re-evaluation Mechanism
Devices included in the catalogue of single-use medical devices must be supported by sufficient evidence proving that they cannot be reused; any device that, through improvements in design, manufacturing process, or disinfection and sterilization technology, can be safely and effectively reused shall be removed from the catalogue and permitted to be reused.
Legal Liability
Where a using entity reuses single-use medical devices, or fails to destroy used single-use medical devices in accordance with the regulations, it shall be penalized in accordance with the law by the drug regulatory departments and health authorities at or above the county level in accordance with their respective duties.
Source: State Council, Regulations on the Supervision and Administration of Medical Devices (State Council Order No. 739), Chinese Government Website, https://www.gov.cn/zhengce/content/2021-03/18/content_5593739.htm