China Announces New Guidelines on Medical Device Manufacturing

The China Food and Drug Administration (CFDA) issued more comprehensive guidelines for manufacturing three types of medical devices: sterile and implantable devices, and in-vitro diagnosis reagents. The guidelines for medical device manufacturing in China come into effect on October 1, 2015.

The guidelines are detailed in three separate appendices: the Announcement on Promulgation of Good Manufacturing Practice for Medical Devices Appendix for Sterile Medical Devices (No. 101 Announcement of 2015); the Announcement on Promulgation of Good Manufacturing Practice for Medical Devices Appendix for Implantable Medical Devices (No. 102 Announcement of 2015); and the Announcement on Promulgation of Good Manufacturing Practice for Medical Devices Appendix for In Vitro Diagnosis Reagents (No. 103 Announcement of 2015).

The guidelines aim to improve the administration and quality management of medical devices in China in order to ensure their safety and efficacy.