Advocacy Actions
Report 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
Read moreLife and Health Industry Cross-Border Cooperation Conference
Life and Health Industry Cross-Border Cooperation Conference
Read moreWorkshop with the German Ministry of Health and Shenzhen Customs on EU Medical Device and In Vitro Diagnostic Regulations
The Deutsche Gesellschaft für Internationale Zusammenarbeit (GIZ) and Shenzhen Customs Authorities jointly hold a workshop together with the German Ministry of Health (BMG) on EU Medical Device (MDR) and In Vitro Diagnostic Regulations (IVDR).
Read moreChina International Medical Device Regulatory Forum (CIMDR)
The Healthcare Equipment (HCE) Working Group and the Chamber's Cooperation Partner COCIR participated in one of the largest medical device regulatory event in the world, the 13th China International Medical Device Regulatory Forum (CIMDR).
Read moreRecommendations to NMPA’s draft Regulations on Administration of Medical Devices for Emergency Use
Recommendations to NMPA’s draft Regulations on Administration of Medical Devices for Emergency Use
Read more