Advocacy Actions
Comments to the MOJ's draft 'Amendment to the Regulation of Medical Device Supervision'
The Healthcare Equipment (HCE) Working Group submitted comments to the Ministry of Justice's (MOJ) draft 'Amendment to the Regulation of Medical Device Supervision'
Read moreComments on the Guangdong HFPC's 'Purchasing Catalogues of Medical Devices: Open for Import / Import Restricted'
The Healthcare Equipment (HCE) Working Group submitted comments on the Guangdong Health and Family Planning Commission's (HFPC) 'Purchasing Catalogues of Medical Devices: Open for Import / Import Restricted'
Read moreComments on the CMDE's draft 'Technical Guideline for the Registration of Disposable Biopsy Needles'
The Healthcare Equipment (HCE) Working Group submitted comments on the Centre of Medical Device Evaluation's (CMDE) draft 'Technical Guideline for the Registration of Disposable Biopsy Needles'.
Read moreComments to the Xuzhou Procurement Leading Group on the '2018 Concept for Procurement of Disposable Medical Devices and IVD'
The Healthcare Equipment (HCE) Working Group submitted comments to the Xuzhou Procurement Leading Group for Sourcing of Disposable Medical Devices and IVD on the '2018 Procurement Plan'.
Read moreLetter to MIIT on Local Filing Requirements for Sales of Radio Devices
The European Chamber’s ICT, SCA and HCE working groups submitted a letter to the Ministry of Industry and Information Technology (MIIT)’s Radio Administration Bureau on the recent filing requirements for sales of radio devices introduced by local radio regulatory authorities.
Read moreComments to the CFDI's draft 'Inspection Points and Determination Principles for Medical Device Clinical Trials'
The Healthcare Equipment (HCE) Working Group submitted comments to the Center for Food and Drug Inspection of CFDA’s (CFDI) draft ‘Inspection Points and Determination Principles for Medical Device Clinical Trials’.
Read moreComments to the CNDA’s draft ‘Amendment for Reviewing Requirements of Renewal Registration and other Application Materials of Medical Devices’
The Healthcare Equipment (HCE) Working Group submitted comments to the China National Drug Administration’s (CNDA) draft ‘Amendment for Reviewing Requirements of Renewal Registration and other Application Materials of Medical Devices’.
Read moreComments to the CNDA's draft 'Technical Guideline for Electronic Submissions'
The Healthcare Equipment (HCE) Working Group submitted comments to the China National Drug Administration's (CNDA) draft 'Technical Guideline for Electronic Submissions'.
Read moreMeeting with the Purchasing Centre for Drugs and Medical Devices of Fujian Province on the "two-invoice system" for disposable medical devices
The Healthcare Equipment (HCE) Working Group hold a meeting with the director of the Purchasing Centre for Drugs and Medical Devices of Fujian Province on the "two-invoice system" for disposable medical devices.
Read moreInput to CMDE's Inquiry on Manufacturers of Human Gene Mutation Detectors
The Centre of Medical Device Evaluation (CMDE) under the China National Drug Administration (CNDA) had asked for input on manufacturers of IVD to detect spontaneous human gene mutations. The Healthcare Equipment (HCE) Working Group submitted consolidated information.
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