Advocacy Actions
Meeting with FDA to Explore Potential Collaborations
A meeting was held between COCIR China Representative Jessica Yuan, Government Affairs Desk Manager Xuanyi Wang, and FDA International Relations Specialist Scott Gonzalez to discuss potential collaborations between the HCE Working Group and FDA. The meeting focused on policy advocacy in China and the possibility of organising a joint training session to provide information on EU and US regulations for stakeholders in China.
Read moreEuropean Chamber Fourth Medical Device Forum
The Healthcare Equipment (HCE) Working Group of the European Chamber, in collaboration with the European Coordination Committee of the Radiological, Electromedical, and Healthcare IT Industry (COCIR), hosted the Chamber's annual medical device forum on September 28, 2023, in Beijing.
Read more2023 Medical Device Economic Information Conference - Closed-Door Meeting Two
2023 Medical Device Economic Information Conference - Engagement in the Field of Medicine Economic Research with NMPA.
The "2023 Medical Device Economic Information Conference," hosted by the Southern Medical and Pharmaceutical Economic Research Institute of the National Medical Products Administration, focused on the theme of "Building a Strong Nation through Intelligent Manufacturing, Focusing on 'Devices' and 'Equipment,' Uniting for a Healthy Future."
Closed-Door Meeting 2 delved into challenges faced by medical enterprises, including market approval and adoption issues.
2023 Medical Device Economic Information Conference - Closed-Door Meeting One
2023 Medical Device Economic Information Conference - Engagement in the Field of Medicine Economic Research with NMPA.
The "2023 Medical Device Economic Information Conference," hosted by the Southern Medical and Pharmaceutical Economic Research Institute of the National Medical Products Administration, focused on the theme of "Building a Strong Nation through Intelligent Manufacturing, Focusing on 'Devices' and 'Equipment,' Uniting for a Healthy Future."
In Closed-Door Meeting 1, experts discussed challenges and opportunities in globalizing medical device enterprises. They explored product innovation, compliant operations, and market strategies.
Feedback on Call for Comments of Implementation Guidelines for Medical Device Recall in Shanghai (Draft)
HCE WG, COCIR, and CDMD Advisory Committee have submitted the feedback to the Shanghai Medical Products Administration for the "Implementation Guidelines for Medical Device Recall in Shanghai (Draft)".
Read moreConference on the Promotion Seminar of the Second Global Digital Trade Exposition
Conference on the Promotion Seminar of the Second Global Digital Trade Exposition
Read moreSymposium with the Center of Medical Device Evaluation (CMDE) on Problems Encountered Due to the Implementation of the New EU Regulations
Symposium with the Center of Medical Device Evaluation (CMDE) on Problems Encountered Due to the Implementation of the New EU Regulations
Read moreTeleconference with Medical Device Supervision Department of NMPA for a Workshop on Medical Device Vigilance
Teleconference with Medical Device Supervision Department of NMPA for a Workshop on Medical Device Vigilance
Read moreMeet with Centre for Drug Re-evaluation
COCIR is exploring the possibility of organising a medical device vigilance training session for the Centre for Drug Reevaluation, NMPA in China. Ms. Zhao Yan, Deputy Director, Center for ADR Monitoring, NMPA, expressed a positive attitude towards the initiative during a recent meeting with COCIR representatives.
Read moreVisit Shanghai Medical Device Testing Institute to Discuss New Chinese Safety Standards and Testing Requirements for Medical Devices
During their visit to the Shanghai Medical Device Testing Institute, COCIR China Representative Jessica Yuan and Government Affairs Desk Manager Xuanyi Wang met with Chief Ms. Yu Hongyi, Deputy Chief Mr. Gao Zhong, and Director of Active Medical Device Testing Department I Mr. Zhuo Yue to discuss the new GB9706 series standards. The report outlines the Institute's desire to provide testing services for innovative products and the importance of enhanced communication and understanding in multi-level technical exchanges. The report also highlights the need for foreign companies to better understand China's policy requirements and the potential challenges in the testing and evaluation process. The Working Group will promptly convey the follow-up issues that the Institute has raised and that require close attention to member companies. The Chamber will also organise exchanges between China and Europe in regards to IEC 60601-1 Edition 3.1.
Read more