Advocacy Actions
COCIR 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 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.
Read moreMeeting with State Administration for Market Regulation
On 19th January 2024, the European Union Chamber of Commerce in China participated a roundtable discussion on continuously optimizing business environment and facilitating high quality development at the State Administration of Market Regulation (SAMR).
Read moreCOCIR China Representatives Met IEC Expert
A meeting was held between COCIR China representatives and IEC expert to discuss standards development and collaboration. Key points covered include obstacles in developing international standards, current Chinese AI/ML and Reliability Standards, business risks of Chinese national standards, training sessions, concerns about the speed of IEC, and the procedure to approve international standards. Next steps include sharing information with members, organising a training session, and advocating for more European companies to join relevant committees.
Read moreFeedback 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).
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