The kick-off meeting for the fourth round of the EU-China Medical Device Expert Roundtable (MDER IV) took place in Beijing on 27 October 2016. It brought together delegates from COCIR and the Chinese Industry Organisation, COCIR China Members and Chinese Company Delegates with Representatives of the Chinese Food and Drug Administration, the European Commission DG GROW and the EU Delegation.
The participants agreed on an 18-month working programme for exchanging information on regulatory requirements in China and EU for medical devices. This will also develop common positions between the Chinese and European medical device industry to present to European and Chinese regulators to allow patients in both countries faster and smoother access to innovative treatment methods.
Within the MDER IV framework, there will be six working groups focusing on the following key areas:
1. Pre-market approvals and product registration, risk classification;
2. Clinical evaluation practice and GCP ;
3. Post Market Surveillance (PMS);
4. Quality Management System (QMS) and Good Manufacturing Practice (GMP) requirements,
5. Medical Software (including IoT and mHealth)
6. In-vitro diagnostics (IVD).
Nicole Denjoy, COCIR Secretary General, present at the meeting, summarised the achievements of the previous three MDER phases. Such process over those phases enabled delivery of more than 70 recommendations, providing valuable input to regulators in both countries. Six spokespeople from COCIR China members presented suggested topics for MDER IV, PPT.
Both CFDA and EU regulators continue to support MDER as observers. A delegate from the European Commission’s DG GROW said, “The EC is paying close attention to the EU-China technical exchange and strongly supports MDER IV. The EC is interested in learning how regulatory changes impact the international medical device market and in working on solutions that support regulators in tackling their challenges”.
For further information, please contact:
COCIR Secretary General
Tel: +32 (0)2 706 8961
COCIR China Desk Business Officer
Tel: +86 10 64622066