Advocacy Actions
Submit comments to CFDA on Operating Procedure of the Inspection to Quality Management System for Domestic Medical Device Registration
Submit comments to CFDA on Operating Procedure of the Inspection to Quality Management System for Domestic Medical Device Registration
Read moreA briefing on Clinical Trial Requirements / Clinical Evaluation to the EU Delegation, Trade Section
A briefing on Clinical Trial Requirements / Clinical Evaluation to the EU Delegation, Trade Section
Read moreSubmit Comments to CFDA on Medical Device Supervision
Submit Comments to CFDA on Medical Device Supervision
Read moreA 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 moreSubmit 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 moreSubmit 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 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.
5th 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.
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