Recently, the Center for Medical Device Evaluation of the State Food and Drug Administration issued the “Publication of the Examination Results for Special Approvals for Innovative Medical Devices”, and agreed to enter into the special approval process for six innovative medical device approval projects. The publicity time is from June 6, 2016 to June 20, 2016.

These 6 products are:

China has approved 66 innovative devices, 9 of which have been listed

The "Special Approval Process for Innovative Medical Devices (Trial)" (Food and Drug Administration [2014] No. 13) has been implemented since March 1, 2014. It has been calculated that the CFDA Inspection Center has been in the past 2 years and 3 months. A total of 20 issues of innovative medical equipment approval applications were published. Among them, there are 7 issues in 2014, 8 issues in 2015, and 5 issues have been released so far in 2016.

In these 20 public announcements, a total of 66 medical device products were included, and 20 have been in 2016. Obviously, from which point of view, CFDA's review and approval of innovative medical devices is increasing.

Of the 66 innovative medical devices, 9 have been approved for marketing. They are:

Among them, the vagus nerve stimulation system of Pinchi Medical has set a fast batch record. The publicity time for entering the special approval process is from December 2, 2015 to December 15, 2015, but it was approved for listing on May 16 this year. It is. It took only 5 months before and after!

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