T/SDMDA 003-2024 Active

Scope: This standard applies to the guidance of the access, transfer of the entrusted process, quality management and continuous improvement of entrusted production for medical device registrants/recorders and entrusted medical device enterprises. It supervises their continuous compliance with the requirements of relevant medical device regulations and standards to ensure that the quality of the entrusted process is controllable and effective. It can be referred to and implemented before the implementation of entrusted activities and during the period of continuous cooperation; Main technical content: This document stipulates the terms and definitions of medical device production and entrusted production, the management process of the entrusted process, the quality management of the entrusting party to the entrusted party (including the access of entrusted medical device enterprises, the transfer of the entrusted process, the quality management of entrusted production and continuous improvement, etc.), the entrusted production within the group, and the termination mechanism of entrusted activities.