Advocacy Actions
Feedback Submitted for Call for Comments on Key Points and Principles for Inspection of Medical Device Clinical Trials (Draft for Solicitation of Comments)
Healthcare Equipment Working Group submitted its feedback for the Call for Comments to the Integrated Affairs Department of the National Medical Products Administration (NMPA).
Read moreSeminar on Medical Device Evaluation
The European Chamber's HCE Working Group the CDMD Desk and the COCIR Desk successfully organized the Seminar on Medical Device Evaluation in Haikou, Hainan, on December 8, 2023. The seminar included guests, such as the Deputy Director General of the Center for Medical Device Evaluation (CMDE) and Directors from the centre's various departments, as well as the Director General of Hainan Boao Lecheng International Medical Tourism Administration and Director General of Hainan Medical Products Administration.
Read moreFeedback to the National Medical Products Administration regarding the Guidelines for the Preparation of Medical Device Instructions for Use (Draft for comment).
On 1st December, the Healthcare Equipment Working Group submitted feedback to the National Medical Products Administration regarding the Guidelines for the Preparation of Medical Device Instructions for Use (Draft for comment).
Read moreCOCIR Representative and HCE Representative Attended 27th GHWP Meetings
COCIR China Representative Jessica Yuan and Government Affairs Desk Manager Xuanyi Wang attended the open sessions of the 27th Technical Committee Meeting and the 27th Annual Meeting of Global Harmonisation Working Party (GHWP) in Shanghai from 27-30 November.
Read moreSubmit comments to SAMR on the Product Quality Law
The Chamber submitted comments to SAMR on the Product Quality Law
Read moreHCE Working Group Representative Attended the 1st 5th Plenary Meeting and Standard Approval Meeting
HCE representative actively participated in the development of comprehensive standards for artificial intelligence medical devices during the 1st 5th Plenary Meeting and Standard Approval Meeting.
Read moreCall for Comments: Feedback of Technical Specification for Clinical Trial Quality of Medical Devices (Draft) to CMDE
The Healthcare Equipment Working Group recently submitted feedback to the National Medical Device Clinical Evaluation Standardisation Technical Centralised Unit regarding the Technical Specification for Clinical Trial Quality of Medical Devices (Draft).
Read moreFeedback on Classification and Definition of Medical Device Products (Draft for Comment) Submitted to NMPA
The Healthcare Working Group has submitted feedback to the General Department of NMPA regarding the Classification and Definition of Medical Device Products (Draft for comment). Their recommendations focus on minimising classification determination time, optimising the information system, simplifying submission requirements, and considering the difficulties faced by import product registrants. These efforts aim to streamline the process and improve efficiency in the medical device industry.
Read moreComments to CAC on Provisions on Regulating and Promoting Cross-border Data Flows (Draft for Comments)
On 15th October, the European Chamber submitted comments to the CAC on Provisions on Regulating and Promoting Cross-border Data Flows (Draft for Comments).
Read moreHealthcare Equipment Working Group Provides Feedback on Quality Management Standards for Online Sales of Medical Devices (Draft for Comments)
The Healthcare Equipment Working Group provided feedback on the Call for Comments for Quality Management Standards for Online Sales of Medical Devices (Draft). The feedback suggests including more detailed provisions regarding quality management responsibilities, fair oversight of self-operated medical device businesses, and safeguarding intellectual property rights.
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