Advocacy Actions
Submit 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.
Read moreMeeting with FDA to Explore Potential Collaborations
A meeting was held between COCIR China Representative Jessica Yuan, Government Affairs Desk Manager Xuanyi Wang, and FDA International Relations Specialist Scott Gonzalez to discuss potential collaborations between the HCE Working Group and FDA. The meeting focused on policy advocacy in China and the possibility of organising a joint training session to provide information on EU and US regulations for stakeholders in China.
Read moreEuropean Chamber Fourth Medical Device Forum
The Healthcare Equipment (HCE) Working Group of the European Chamber, in collaboration with the European Coordination Committee of the Radiological, Electromedical, and Healthcare IT Industry (COCIR), hosted the Chamber's annual medical device forum on September 28, 2023, in Beijing.
Read more2023 Medical Device Economic Information Conference - Closed-Door Meeting Two
2023 Medical Device Economic Information Conference - Engagement in the Field of Medicine Economic Research with NMPA.
The "2023 Medical Device Economic Information Conference," hosted by the Southern Medical and Pharmaceutical Economic Research Institute of the National Medical Products Administration, focused on the theme of "Building a Strong Nation through Intelligent Manufacturing, Focusing on 'Devices' and 'Equipment,' Uniting for a Healthy Future."
Closed-Door Meeting 2 delved into challenges faced by medical enterprises, including market approval and adoption issues.
2023 Medical Device Economic Information Conference - Closed-Door Meeting One
2023 Medical Device Economic Information Conference - Engagement in the Field of Medicine Economic Research with NMPA.
The "2023 Medical Device Economic Information Conference," hosted by the Southern Medical and Pharmaceutical Economic Research Institute of the National Medical Products Administration, focused on the theme of "Building a Strong Nation through Intelligent Manufacturing, Focusing on 'Devices' and 'Equipment,' Uniting for a Healthy Future."
In Closed-Door Meeting 1, experts discussed challenges and opportunities in globalizing medical device enterprises. They explored product innovation, compliant operations, and market strategies.