Advocacy Actions
A briefing on Clinical Trial Requirements / Clinical Evaluation for upcoming IMDRF meeting and JCCT meeting
A briefing on Clinical Trial Requirements / Clinical Evaluation for upcoming IMDRF meeting and JCCT meeting
Read moreLobby Letter to China CFDA – Missing Ingredients
On 10 September 2014, the Cosmetic Working Group submitted a thanks letter to the China Food and Drug Administration to appreciate their written response on our previous report regarding the suspicious missing ingredients based on the published 8783 version used ingredients list, and raise another industrial concern to the registration department.
Read moreMeeting with DG WTO Affairs, MOFCOM
On September 3rd, European Chamber representatives led by Vice President Sara Marchetta met with Madame Zhao Hong, Director General and Chief WTO Negotiator of MOFCOM’s WTO Affairs Department.
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)
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