Healthcare Equipment Working Group Position Paper 2018/2019 - 医疗器械工作组建议书2018/2019 Go back »

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Medical devices, including in-vitro diagnostics (IVD), play a crucial role in the prevention, diagnosis and treatment of diseases, while supporting and monitoring the convalescence of patients in hospitals, clinics and homecare. Therefore, medical devices are key to improving the overall health of the population as laid down in the strategic plan Healthy China 2030. Working group members invest heavily to develop innovative treatments, and fully support the government’s efforts to ensure patients’ access to state-of-the-art, safe, efficacious and affordable medical devices.

The European Chamber ’s Healthcare Equipment Working Group consists of 90 member companies—multinationals and small and medium-sized enterprises—that develop and manufacture indispensable, life-saving and disease-reducing diagnostic and therapeutic technologies. The working group members maintain this commitment by investing in modern Chinese research, development and production facilities, as well as in the education of Chinese doctors and healthcare professionals.

This working group has established regular contact with major stakeholders both in China and in Europe. It organises regular meetings with the China National Drug Administration (CNDA), as well as with the National Health Commissions (NHCs) at different government levels, to get first-hand information on regulatory and healthcare policy developments, and to present suggestions from the European medical device industry.

To enhance international cooperation, in 2007, the working group established contact with the European Coordination Committee of the Radological, Electromedical and Healthcare IT Industry (COCIR), a major medical technology industry association based in Europe.

In April 2014, the European Chamber founded  the Consumable and Medical Devices (CDMD) Advisory Committee, a group consisting of Chinese subsidiaries of international market leaders in the field of consumable medical devices and IVD. This advisory committee has founded two subgroups – Regulatory Affairs and Government Affairs.

The working group actively supports the European Union (EU)-China Medical Devices Expert Roundtable, a joint initiative between European and Chinese medical device manufacturers with the aim of narrowing the gap between the different regulatory systems of China and Europe.

The Healthcare Equipment Working Group wishes to further engage in a continuous and constructive dialogue with all relevant government agencies, both at the national and provincial/local level in China.

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