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 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 moreFeedback on Call for Comments of General Interventional and Neurosurgical Medical Consumables Tender Invitation Documents of Henan Province led Alliance
The Healthcare Equipment (HCE) Working Group and Consumable and Disposable Medical Device (CDMD) Government Affairs Committee have submitted feedback on the call for comments for the volume-based procurement tender invitation documents for general interventional and neurosurgical medical consumables in Henan Province led alliance. Key suggestions include refining tender rules to achieve fairness and keeping mainstream products in the market.
Read moreAdvocacy Letter on Issues with Fourth Batch of Centralised Procurement of Medical Consumables in Hebei Province by Healthcare Equipment Working Group and CDMD Desk
The Healthcare Equipment Working Group and Consumable and Disposable Medical Device Committee wrote a letter to the Hebei Province regarding issues with its centralised procurement of medical consumables, recommending a "one strategy for one product" approach prioritising mature products with adequate market competition for volume-based procurement and better communication with the Hebei Healthcare Security Administration.
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