Announcement of the State Food and Drug Administration on the Issuance of the Appendix to the Quality Management Standards for Medical Device Business: Quality Management of Enterprises Specializing in the Transportation and Storage of Medical Devices

(No. 94 in 2022)

In order to strengthen the supervision and management of the operation of medical devices and standardize the quality management of enterprises specialized in providing transportation and storage services of medical devices, according to the Regulations on the Supervision and Administration of Medical Devices (Order No. 739 of the State Council) and the Measures for the Supervision and Administration of the Operation of Medical Devices (Order No. 54 of the General Administration of Market Supervision and Administration of the People's Republic of China), The State Drug Administration has organized the formulation of the Appendix to the Quality Management Standards for Medical Device Business: Quality Management of Enterprises Specializing in the Transportation and Storage of Medical Devices, which is hereby promulgated and will come into force as of January 1, 2023.

This appendix is the special requirements of the business quality management specifications of enterprises that provide transportation and storage services of medical devices. The operation quality management system of enterprises that provide transportation and storage services for medical devices shall comply with the requirements of the Medical Device Operation Quality Management Standard and this appendix.

It is hereby announced.

Appendix: Medical Device Operation Quality Management Norm Appendix: Quality Management of Enterprises Specialized in Medical Device Transportation and Storage Services

State Food and Drug Administration

October 31, 2022