On October 27, 2016, the kick-off meeting for the Fourth Europe-China Medical Devices Expert Roundtable (EU-China MDER IV) was held in Beijing, co-hosted by China Food and Drug Administration (CFDA) and European Commission’s Directorate General for Internal Market, Industry, Entrepreneurship and Industry (DG GROW). The project cooperators consist mainly of China Society for Drug Regulation (CSDR), Committee for International Exchange and Cooperation (CIEC), China Association for Medical Devices Industry (CAMDI), European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry (COCIR), European Diagnostic Manufacturers Association (EDMA) and European Union Chamber of Commerce in China (EDMA).

After in-depth discussion, more than thirty experts from business circles, notified bodies and other related fields unanimously decided through consultation to discuss in EU-China MDER IV the following six issues:
1. Pre-market product registration and classification;
2. Clinical practice evaluation and medical device clinical trials;
3. Post-market surveillance;
4. Requirements of quality management system and production quality management standards;
5. Medical software (including Internet+ and related innovative technologies of the mobile medical applications);
6. In-Vitro diagnostic products.

It is reported that EU-China MDER IV will establish working groups in November, 2016 (a total of six working groups in terms of the above six issues) with a convener assigned for each group, determine specific research hotspots based on the discussion at the kick-off meeting, hold a teleconference of EU-China experts at regular intervals, build a platform for members of working groups, prepare and submit the Final Report for MDER IV.