Healthcare Equipment Working Group Position Paper 2016/2017 - 医疗器械工作组建议书2016/2017
by:Healthcare Equipment Working Group / Forum
The European Chamber’s Healthcare Equipment Working Group consists of 90 member companies— multinationals and small- and medium enterprises (SMEs)—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.
The working group has established regular contacts with major stakeholders both in China and Europe. It organises regular meetings with the China Food and Drug Administration (CFDA) and its sub-organisations, as well as with the Health and Family Planning Commissions (HFPCs) at different government levels, to get first-hand information of regulatory and healthcare policy developments in China and to present concerns and suggestions of the European medical device industry.
To enhance international cooperation, in 2007, the working group established contacts with the European Coordination Committee of the Radiological, Electro medical and Healthcare IT Industry (COCIR), a major medical technology industry association based in Europe. In China, COCIR has six focus groups: Code of Conduct, Environment, Remanufacturing, eHealth, Regulatory Affairs and Standardisation; as well as two task forces: Medical Software and Clinical Evaluation & Trials.
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 high-value consumable medical devices. The advisory committee has founded two subgroups—Regulatory Affairs (RA) and Government Affairs (GA)—as well as a Clinical Trial Task Force, to facilitate the development of the highvalue consumable medical device industry.
The Healthcare Equipment Working Group wishes to further engage in a continuous and constructive dialogue with all relevant government agencies, both on a national and a provincial/local level in China.