Advocacy Actions
The 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).
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 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.
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