Third-party logistics (3PL) for medical devices in China have been duly regulated according to the respective province. This meant that a total of 39 regulatory guidelines have been issued by the local Medical Products Administrations (MPAs). In order to solve the underlying problem of inconsistency, the NMPA (National Medical Products Administration) has decided to implement a unified set of quality management system (QMS) requirements at the national level.
On June 10, 2022, the NMPA released the draft requirements for the quality management system of third-party logistics for medical devices in China. The draft serves as an appendix to the Good Supply Practice (GSP) for medical devices, and it is currently open for public comments until June 20, 2022.
The GSP for medical devices (No.58-2014) was announced by the NMPA in 2014 to support the implementation of the “Administrative Measures for the Supervision of Medical Device Business Operation”. The Administrative Measures have been amended recently and came into effect on May 1, 2022. Read our separate blog post for more information.
Background to the draft QMS for medical device 3PL in China
During the period between April and December 2021, the NMPA initiated the process to update the GSP appendix. The NMPA actively carried out public consultations and internal meetings with different groups of provincial MPAs, local regulatory departments, industry associations, 3PL enterprises, etc. A total of 383 comments were collected in December 2021, and a closing conference was held by the NMPA in May 2022.
According to the draft, a “3PL provider for medical devices” is defined as an enterprise specialized in the provision of transportation and storage services to medical device registrants, filers, and related operating businesses.
Prior to offering such services, the 3PL company should already possess the required credentials such as a medical device business license, filing certificate for business activities, etc. In addition, the draft lists out the basic capabilities of a medical devices 3PL provider including, but not limited to the following:
- real-time access to a synchronized electronic data interface that is also accessible to the China regulatory departments and 3PL service users
- access to the information platform for the unique device identification (UDI) system for the traceability of medical devices during transport or storage
- a fully implemented and operational quality management system for transportation and storage services
If you would like to learn more about 3PL for medical devices in China or our registration and CRO services for medical devices, IVDs, pharmaceuticals, cosmetics or other products, please contact Cisema.
How to submit your comments on the draft QMS requirements for medical device 3PL in China
The deadline for comments is June 20, 2022. Cisema customers may submit their comments to their respective regulatory affairs project manager otherwise comments may be sent directly to firstname.lastname@example.org.
By Jacky Li and Victoria Caldy.