Advocacy Actions
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.
Read moreFeedback submitted for Call for Comments on Fourth Round of Centralised Medical Consumables Procurement in Fujian Province
The Healthcare Equipment Working Group has submitted feedback for the Call for Comments on the Draft on the Fourth Round of Centralised Medical Consumables Procurement in Fujian Province, recommending adjustments to procurement volumes, product catalogues, working processes, and overall supporting policies to ensure the practical implementation of Volume-Based Procurement.
Read moreReport on Efforts by Healthcare Equipment Working Group, CDMD, and COCIR to Address COO Requirements for Registration of Imported Medical Devices in China
Report on Efforts by Healthcare Equipment Working Group, CDMD, and COCIR to Address COO Requirements for Registration of Imported Medical Devices in China. The inclusion of country of origin in the documentation required for registration has resulted in slower approval of imported products in China. The joint efforts of the Healthcare Equipment Working Group, Consumable and Disposable Medical Device Desk (CDMD), and COCIR demonstrate their commitment to advocating for a more streamlined process for the registration of imported medical devices in China. Find out what they discovered in their report.
Read moreSubmission of the Comments on Fourth Batch National Volume-based Procurement of High-Value Medical Consumables Draft
The Healthcare Equipment Working Group submitted comments on the Fourth Batch National Volume-based Procurement of High-Value Medical Consumables draft. They suggested allowing industry enterprises to grow in the centralized procurement of sports medicine products, with tenders awarded to companies that achieve price reductions. It is important to establish clear rules with the involvement of companies and to consider the industry's requirements for innovation and development.
Read moreMeeting with European Commission Trade Counsellor on Healthcare Equipment Working Group Issues
The Healthcare Equipment Working Group met with Helene Juramy, the trade counsellor from the Delegation of the European Commission to discuss public procurement and imported medical devices. Both parties expressed commitment to promoting fair trade practices in the healthcare equipment industry. Learn more about the meeting outcomes.
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