Advocacy Actions
Comments on the Guidelines for Review of Registration Changes of In Vitro Diagnostic Reagents (Draft for Comments)
The Consumerable and Disposable Medical Device Desk provides feedback on draft guidelines for registration changes of in vitro diagnostic reagents. The guidelines propose adding clauses to prevent repeated applications for the same matter, and may not require a risk analysis report for changes if risks can be directly determined without increased risks.
Read moreCall for Comments on the Measures for the Administration of Advertisement Review of Drugs, Medical Devices, Health Food and Food for Special Medical Purposes (Draft)
On 28th June, the Agriculture, Food and Beverage Working Group, the FSMP Advisory Committe (Sub-working Group), Healthcare Equipment Working Group and Pharmaceutical Working Group submitted comments to the State Administration for Market Regulation on the Measures for the Administration of Advertisement Review of Drugs, Medical Devices, Health Food and Food for Special Medical Purposes (Draft).
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 moreLife and Health Industry Cross-Border Cooperation Conference
Life and Health Industry Cross-Border Cooperation Conference
Read moreMeeting with the Department of development and Research of China Council for the Promotion of International Trade (CCPIT)
On 6th April, the European Chamber met with the representatives from the Department of development and Research of China Council for the Promotion of International Trade (CCPIT). Bruce Fu, Chair of Government Affairs Forum, and Xiaowen Ma, Chair of Cybersecurity Sub-working Group, shared feedback and suggestions from European Chamber's member companies regarding market access and especially cross-border data flows.
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
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