Medical devices "five methods" October formally implemented
The State Food and drug supervision and management administration system revised "medical devices registration management measures", "in vitro diagnostic reagents registration management measures", "medical device user manual and label management regulations", "medical device manufacturing supervision and management measures", "medical equipment business supervision and management measures" and other regulations of the Ministry of five, formally implemented in October 1st. The new version of "medical devices registration management measures" compared to the previous edition, clear clinical trial approval time is 63 working days, the product registration total period of 128 working days for approval, and special instruments such as coping with sudden public health events needed medical equipment Easy Access first opened after the approval of registration.
