EU-China Medical Device Expert Roundtable (MDER) III Plenary Meeting
2014-09-01 | Beijing
MDER is with the purpose to study and compare the EU and China Medical Device regulatory requirements, and then give recommendations to both EU and China authorities, for a harmonized regulatory system. MDER III focus on below topics -
· WG 1 : Medical Device Registration submission requirements, and product changes’ registration
· WG 2 : Clinical evaluation
· WG 3 : In-Vitro Diagnostic (IVD)
At the plenary, each working group presented their findings and recommendations
CFDA and DG SANCO summarized at the end -
CFDA：
CIMDR serves as a wonderful platform in which Chinese participation has increased. It embodies bilateral wished and benefits CFDA-DG SANCO cooperation;
Though we cannot answer all these questions one by one today, we will make detailed research afterwards;
Training programs in the industry will be launched in many ways;
Details should be specified in future regulations;
A series of new regulations is under its way to be introduced and comments will be called;
Many other channels are available for you to make suggestion to CFDA after CIMDR, such as COCIR.
DG SANCO：the success of this meeting is dedicated to the following factors
Great cooperation among working groups;
It is very clear and concrete with only three subjects for discussion;
The experiences of previous two CIMDR meetings are learned.