Advocacy Actions
Symposium 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 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 moreMeeting with Medical Device Supervision Dept. of the NMPA on National Implementation Requirements of Relabelling (related to Provisions of Annex 8-E of the Comprehensive and Progressive Trans-Pacific Partnership (CPTPP) Agreement)
Meeting with Medical Device Supervision Dept. of the NMPA on National Implementation Requirements of Relabelling (related to Provisions of Annex 8-E of the Comprehensive and Progressive Trans-Pacific Partnership (CPTPP) Agreement)
Read moreSeminar on Artificial Intelligence Medical Device Administration
The workshop was organized by the Center of Medical Device Evaluation to address regulatory requirements for AI medical devices. Objective: Enhance regulatory requirements for artificial intelligence medical devices in alignment with the Ministry of Science and Technology's research project "New Generation of Artificial Intelligence (2030)."
Symposium on Technical Review of Medical Devices with the Center for Medical Device Evaluation (CMDE)
Symposium on Technical Review of Medical Devices with the Center for Medical Device Evaluation (CMDE)
Read moreMeeting with the Development and Research Centre (DRC) of the State Council on Healthcare Industry
Meeting with the Development and Research Centre of the State Council on Healthcare Industry
Read moreNational Institute for Food and Drug Control (NIFDC) Visit to Germany COCIR China gave presentation virtually
Introduction of the Transformation and Implementation Progress of IEC 60601 in China and in Europe during the NIFDC's visit to Germany
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