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 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 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 moreAdvocacy Letter to Fujian Healthcare Security Administration for "Two-invoice System"
The Consumable and Disposable Medical Device Advisory Committee (CDMD) advised Fujian Healthcare Security Administration to allow compliant companies to participate in distribution, increase the number of distributors, and rescind invoice requirements for certain transfers. The CDMD also requested a meeting to discuss these issues.
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 moreHealthcare Equipment Working Group Submitted Comments to Healthcare Security Administration of Jiangsu Province
The Healthcare Security Working Group submitted comments to Jiangsu Provincial Healthcare Security Administration on "Catalogue of Medical Consumables for Basic Medical Insurance in Jiangsu Province (Draft for Comments)".
Read moreHealthcare Equipment Working Group Provided Feedback to Anhui Healthcare Security Administration
The Healthcare Equipment Working Group provided feedback on a draft titled "Implementation Opinions on Further Strengthening the Management of Medical Consumables Procurement in Public Medical Institutions" to Anhui Healthcare Security Administration.
Read moreHealthcare Equipment Working Group Provided Feedback to Shanghai Municipal Medical Products Administration
Healthcare Equipment Working Group Submitted Comments to the Shanghai Municipal Medical Products Administration on Provisions for Attaching Chinese Labels to Imported Medical Devices in China (Shanghai) Pilot Free Trade Zone (Trial) (Exposure Draft).
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.
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