Advocacy Actions
Meeting with Representatives from Hainan Lecheng and the China Association of Medical Equipment
On 20th of August, Jessica Yuan, the representative of the Healthcare Equipment Working Group of the European Chamber, met with Ruohan Zhang, Deputy Director of the Zhenyan Division at the Lecheng Management Bureau and Head of the Lecheng International Innovation Medical Device Incubation Center.
Read moreHCE Working Group Submits Feedback to Standing Committee of the Guangdong Provincial People's Congress
The Healthcare Equipment Working Group praised the revised import regulations for Guangdong but suggested improvements in procurement, medical insurance code applications, and consumable code synchronisation.
Read moreCOCIR Representative Attended and Delivered a Keynote Speech at the Forum on Innovation for Health-New Mechanism for Innovative Pharmaceuticals and Medical Equipment Going Global
On 18th July, COCIR China representative attended and delivered a keynote speech at the Forum on Innovation for Health-New Mechanism for Innovative Pharmaceuticals and Medical Equipment Going Global hosted by Boao Forum for Asia and the People’s Government of Beijing Municipality.
Read moreMeeting on Strengthening the Management of the Service Life of Active Medical Devices in Use
On 11th July, representative of COCIR attended the Meeting on Strengthening the Management of the Service Life of Active Medical Devices in Use, held by National Medical Products Administration (NMPA).
Read moreMeeting with the Representatives from the China Association of Medical Equipment
On 3rd of July, Representatives of the Healthcare Equipment Working Group of the European Chamber, Jessica and Xuanyi, met with the representatives from the China Association of Medical Equipment.
Read more5th Anniversary of the Clinical Real-World Data Application Pilot in Boao Lecheng International Medical Tourism Pilot Zone
On the 20th of June, Jessica attended the Medical Device Real-World Research Closed Door Meeting of the 5th-anniversary meeting of the Clinical Real-World Data Application Pilot at Boao Lecheng International Medical Tourism Pilot Zone.
Read moreEuropean Chamber President meets with Joanna Szychowska, Director at DG TRADE
On 15th April, a delegation of European Chamber representatives led by President Jens Eskelund met with Joanna Szychowska, Director at DG TRADE, and other visiting officials.
Read moreThe Consumable and Disposable Medical Device Advisory Committee and the COCIR Registration Affairs Taskforce Submitted a Letter to the National Medical Products Administration on the Issues of Product Service Life and Dynamic Management
The Consumable and Disposable Medical Device Advisory Committee and the COCIR Registration Affairs Taskforce have written to the National Medical Products Administration. They expressed concern about equating a product's service life with product failure, clarifying that the term "service life" should be interpreted as "expected service life". They also proposed that medical device end users should be allowed to manage the "expected service life" of their devices dynamically, potentially extending the use of products beyond their "expected service life" based on regular evaluations and maintenance records.
Read moreSeminar with China Academy of Information and Communications Technology (CAICT)
The COCIR Desk had a meeting with the China Academy of Information and Communications Technology (CAICT) on the 21st of March.
Read moreHCE Working Group Provides Feedback on Proposed Lithium-Ion Battery Standards for Portable Medical Devices
The HCE Working Group provided feedback on MIIT's proposals for safety and general specifications for lithium-ion cells and batteries in portable medical devices. They sought clarification on compliance for manufacturers sourcing batteries externally and requested detail on standard requirements for manufacturers and suppliers. They also suggested aligning the proposed standard with existing ones like IEC62620 and recommended revising ambiguous text for clarity.
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