On November 2022, China’s NMPA issued the Announcement on “Appendix to Good Operating Practices for Medical Devices: quality Management of Enterprises Providing Transportation and Storage Services for Medical Devices”.
This appendix is a special requirement for the quality management practices of enterprises that provide medical device transportation and storage services. The operation quality management system of enterprises that provide medical device transportation and storage services shall comply with the requirements of the “Quality Management Regulations for Medical Device Operation” and this appendix.
This appendix is a special requirement of good practice for enterprises that specially provide medical device transportation and storage services.
The requirements for personnel:
- Facilities and equipment of enterprises specializing in the transportation and storage of medical devices.
- Responsibilities of both the contract giver and the entrusted enterprise entrusted to provide medical device transportation and storage services.
- The business quality management system of enterprises specially providing transport and storage services for medical devices shall comply with the requirements of Good Operating Practices for Medical Devices and this appendix.
When does it go into effect?
- This appendix shall enter into force as of January 1, 2023
To read more about the appendix click here:
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