Advocacy Actions
Submitted Comments on Implementation Opinions of the State Administration for Market Regulation on Promoting Traceability of Quality Safety of Key Industrial Products (Draft for Comments) to the SAMR
On 30th August, the Chamber submitted comments from Environment, Standards and Conformity Assessment, Healthcare Equipment, and Quality and Safety Services working groups on the Implementation Opinions of the State Administration for Market Regulation on Promoting Traceability of Quality Safety of Key Industrial Products (Draft for Comments) to the SAMR.
Read moreMeeting with the State Administration for Market Regulation (SAMR) on Digitalisation of Product Labelling, Markings, and In-Box materials
On 23rd August 2024, the European Chamber representatives paid a visit to the SAMR and met up with Mr Li Zhenghai Division II Director of Regulatory Affairs Department, and his colleagues from departments of international affairs, quality supervision, quality development, and standard innovation.
Read moreMeeting 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 Zhejiang Province Healthcare Security Administration
The Healthcare Equipment Working Group advised annual evaluations, a green channel for major innovations, relaxed submission rules, and yearly price adjustments for generic items in Zhejiang. They also recommend adopting continuous evaluation practices from other provinces.
Read moreHCE Working Group Submits Feedback to National Development and Reform Commission
The Healthcare Equipment Working Group recommended to the National Development and Reform Commission to reduce or cancel renewal fees for medical devices, unify fees for all devices, simplify standard upgrade registrations, and offer discounts and expedited processes for innovative products.
Read moreHCE Working Group Submits Supporting Document to NMPA
The HCE Working Group submitted a document on EU and US regulations for extended use of medical equipment to the NMPA for further study.
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 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 moreHCE Working Group Submitted Feedback to NMPA
On 1 July, the Healthcare Equipment Working Group (HCE) provided feedback to the NMPA on the Medical Device Classification Directory adjustments. Key points included updating device descriptions, adding new device categories, and ensuring accurate classifications for various medical equipment.
Read moreHealthcare Equipment Working Group Provided Feedback to Shaanxi Provincial Healthcare Security Administration
The Healthcare Equipment Working Group provided feedback to the Shaanxi Provincial Healthcare Security Administration on a draft called "Notice on Further Improving the Centralized Purchasing of Medical Consumables by the Shaanxi Provincial Healthcare Security Administration".
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