Advocacy Actions
Meeting with the Center for Drug Re-evaluation for implementing Order#1 of SAMR
The Healthcare Equipment (HCE) Working Group and European Coordination Committee of the Radiological, Electromedical And Healthcare IT Industry (COCIR) visited the Center for Drugs (Medical Devices) Re-evaluation (CDR) of National Medical Products Administration (NMPA) on 29th December 2018.
Read moreComments to the CDR’s “Guideline for the Re-evaluation of Medical Devices”
On 27 November 2018, the Centre for Drug Re-evaluation has initiated a public consultation on “Guideline for the Re-evaluation of Medical Devices”.
Read moreComments to the CDR’s “Guideline for the Risk Assessment by the Medical Device Market Authorisation Holder (MAH)”
On 27 November 2018, the Centre for Drug Re-evaluation has initiated a public consultation on “Guideline for the Risk Assessment by the Medical Device Market Authorisation Holder (MAH)”.
Read moreSeminar on the 'Guideline for Evaluating the Risk-Benefit Ratio of Medical Devices'
The Healthcare Equipment (HCE) Working Group participated in a Seminar on the ''Guideline for Evaluating the Risk-Benefit Ratio of Medical Devices'
Read moreComments to the CMDE's draft 'Guideline on the Comparison of IVD with Equivalent Products During Clinical Studies'
The Healthcare Equipment (HCE) Working Group submitted comments to the Centre of Medical Device Evaluation's (CMDE's) draft 'Guideline on the Comparison of IVD with Equivalent Products During Clinical Studies'
Read moreComments to the CMDE's draft 'Guideline for Clinical Studies of IVD'
The Healthcare Equipment (HCE) Working Group submitted comments to the Centre of Medical Device Evaluation's (CMDE's) draft 'Guideline for Clinical Studies of In-Vitro Diagnostics (IVD) Reagents'.
Read moreCMDE Seminar on Animal Studies for Medical Devices
The Healthcare Equipment (HCE) Working Group participated in a seminar of the CMDE under which conditions medical devices should undergo animal studies for registration.
Read moreSeminar on the 'Guideline for Biological Evaluation of Medical Devices'
The Healthcare Equipment (HCE) Working Group participated in a Seminar on the 'Guideline for Biological Evaluation of Medical Devices, Part 1: Basic Principles'
Read moreChamber Presents Position Paper to State Medical Insurance Administration (SMIA)
On 6th December, a Chamber delegation was received by Mr Shi Zihai, Vice Commissioner of the State Medical Insurance Administration (SMIA, also known as the National Healthcare Security Administration). At the meeting, Vice Commissioner Shi gave an overview of SMIA’s structural organisation and recent work priorities, including the reforming the list of medicines covered by national medical insurance and payment and procurement pilot programs.
Read moreMedical Device Inspection Seminar 2018
The Healthcare Equipment (HCE) Working Group participated in the two-days Medical Device Inspection Seminar 2018, organised by the Centre for Food and Drug Inspection of the NMPA and the China Centre for Food and Drug International Exchange.
Read more