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 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 moreSymposium 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 Medical Service Department of National Healthcare Security Administration
On 21st March, the Chair of Consumable and Disposable Medical Device Advisory Committee (CDMD AC) visited the National Healthcare Security Administration (NHSA), and met with the Division of Catalogue Management. The Division director welcomed delegates from the Chamber and expressed appreciations for chamber’s support to the NHSA.
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 moreMeeting with Fujian Vice Governor Wang Jinfu
On 14th February, Fujian Vice Governor Wang Jinfu visited the European Chamber Beijing office.
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