Circular (No. 15 of 2014)
Issued on September 05, 2014
Circular of the State Food and Drug Administration
Circular
No. 15 of 2014
On the Circular on Matters Relating to the Implementation of the Good Manufacturing Practice for Medical Devices
In order to promote the implementation of the Good Manufacturing Practice for Medical Devices, and in accordance with the Regulations for the Supervision and Administration of Medical Devices (State Council Decree No. 650) and Measures for the Supervision and Administration of Medical Device Manufacturing (State Food and Drug Administration Decree No. 7), the following matters are hereby notified:
I, Sterile and implantable medical device manufacturers should continue in accordance with the requirements of the quality management standard for the production of medical devices, to establish and improve the production of medical devices and ensure the effective operation of the quality management system.
Since October 1, 2014, all new medical device manufacturers, existing medical device manufacturers to increase the production of Class III medical devices, relocation or increase the production site, should comply with the requirements of the quality management standard for the production of medical devices.
Three, since January 1, 2016, all class III medical device manufacturers shall comply with the requirements of the Good Manufacturing Practice for Medical Devices.
Four, since January 1, 2018, all medical device manufacturers should comply with the requirements of the quality management standard for the production of medical devices.
V, medical device manufacturers should actively in accordance with the quality management standard for the production of medical devices and related requirements for the control and rectification, and constantly improve the quality management system, comprehensively improve the quality management and security capabilities, within the specified time limit to meet the requirements of the quality management standard for the production of medical devices. Before the specified time limit is still in accordance with the existing provisions.
VI, food and drug supervision and management departments at all levels should effectively strengthen the implementation of medical device production quality management standard of publicity and guidance, in the specified time limit did not meet the requirements of medical device production quality management standard of the production enterprise, should be in accordance with the "supervision and management of medical devices regulations" relevant provisions of the treatment.
This notice is hereby issued.
State Food and Drug Administration
September 5, 2014