In accordance with the Decision of the State Council on Amending and Repealing Certain Administrative Regulations, the State Council has conducted a second revision of the Regulations on the Supervision and Administration of Medical Devices. This revision includes two amendments:
- The phrase "the competent health authority under the State Council" in Article 19, Paragraph 2 has been revised to "the competent health authority under the State Council and the disease prevention and control authority under the State Council."
- The term "family planning technical service institutions" has been removed from Article 103.
See the table below for a detailed comparison:
| Relevant Article | 2021 Version | 2025 Version |
|---|---|---|
| Article 19 | In the event of a particularly major public health emergency or other urgent incidents posing a serious threat to public health, the competent health authority under the State Council may propose the emergency use of medical devices based on the needs of prevention and control. Upon demonstration and approval organized by the drug regulatory authority under the State Council, such devices may be used within a defined scope and period under emergency conditions. | In the event of a particularly major public health emergency or other urgent incidents posing a serious threat to public health, the competent health authority under the State Council and the disease prevention and control authority under the State Council may propose the emergency use of medical devices based on the needs of prevention and control. Upon demonstration and approval organized by the drug regulatory authority under the State Council, such devices may be used within a defined scope and period under emergency conditions. |
| Article 103 | Medical device user entities refer to institutions that use medical devices to provide medical and other technical services to others. These include medical institutions, family planning technical service institutions, blood stations, plasmapheresis stations, and rehabilitation assistive device adaptation institutions. | Medical device user entities refer to institutions that use medical devices to provide medical and other technical services to others. These include medical institutions, blood stations, plasmapheresis stations, and rehabilitation assistive device adaptation institutions. |
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Reference:
Regulations on the Supervision and Administration of Medical Devices (2025 Edition)