Advocacy Actions
Working Group Meeting on the Revised Consumer Protection Law
The Agriculture, Food and Beverage Working Group invited Ms. Jiaoli Zhao, Deputy Director, Shanghai Consumer Council to give a talk on the Revised Consumer Protection Law.
DG SANCO Meeting with China Food and Drug Administration
DG SANCO, CFDA, Chinese experts and EU experts in the cosmetics industry had a whole day communication and exchange on the regulatory and technical issues on 2 September. It was a very open discussion, and very well participated. All parties welcomed such a good communication opportunity, and agreed that it was a very healthy way to cooperate for both regulators and experts in China and EU side. In the morning session, EU experts introduced Animal Testing Bans in the EU and Status of Alternative methods, detailed introduction of the Safety Assessment Procedure of Finished Products and Efficacy Assessment Guideline on Cosmetics. In the afternoon session, CAFCCI expert and Shi Yue from IMPLAD introduced the 8783 version used ingredients list and responded to our reported suspicious missing ingredients by EUCCC Cosmetics Working Group. EU experts introduced the principles and Practical Aspects of Labelling of Cosmetics in the EU. Director Qi Liubin introduced the process of new ingredients registration, domestic non functional on line notification and imported non functional decentralization.
Submit Comments to CFDA on Guidance for Clinical Evaluation
Submit Comments to CFDA on Guidance for Clinical Evaluation
Read moreEU-China Medical Device Expert Roundtable (MDER) III Plenary Meeting
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)
Submit Comments to CFDA on Guidance for Clinical Trials of IVD Reagents> and <Guidance for Compiling Instructions for IVD Reagents
Submit Comments to CFDA on Guidance for Clinical Trials of IVD Reagents> and <Guidance for Compiling Instructions for IVD Reagents
Read moreSeminar on China's New Regulations of Medical Device
To prepare for this seminar, EUCCC, jointly with Amcham, as well as China Association for Medical Device Industry (CAMDI), had meetings with members and consolidated comments / suggestions, and submitted to CFDA, requesting for clarification/advice from CFDA during the seminar.
Mr. Zhang introduced overall revisions of medical device regulations from Legal perspective. SUN briefed about ideas for post-market surveillance supervision, manufacturing, distributing. DENG presented mainly for medical device registration regulations’ revision.
Submit Comments to CFDA on Naming Rules for Medical Equipment (Draft for Comment)
Submit Comments to CFDA on Naming Rules for Medical Equipment (Draft for Comment)
Read moreRoundtable with the Standing Committee of the Chinese National People’s Congress (NPC)
Representatives from the European Chamber were invited to the roundtable discussion on the Food Safety Law organised by the NPC. During the discussion, relevant stakeholders addressed their concerns on the latest draft Food Safety Law
Read more5th China International Medical Device Regulatory (CIMDR) Forum
The 5th CIMDR was held under the revision of Regulations for Supervision and Administration of Medical Devices (Order 650) was released by the State Council, and was enforced since 1st June, 2014. All other sub-regulations of Order 650 either have been published, or will soon be published. Industry is eager to exchange ideas on medical device supervision with regulators, reviewers, engineers from test institutes, hospitals, notify bodies, international institutions, and experts from industry. COCIR-EUCCC is one of the most important Co-organizers, who worked with members, designing and fulfilling topics, speakers for both plenary meeting and sub-forums.
Read moreMeeting with CATR
On 27th August, the ICT WG Vice Chair Bruce Fu and BM Lanna Wu had working-level meeting with Ms. Li Haiying, Law Dept.Director, Institute of Economy and Policy Research, CATR of MIIT. The discussion covered MVNO market opening timeline, VATS Catalog, China Telecom Law revision as well ICT companies comments on the SHFTZ.
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