When the European Union and China convene to discuss topics such as medical device standards, it seems that just about any organization with a clunky acronym for a name can join the discussion.
The EU-China Trade Project (EUCTP) last year endorsed a series of medical device expert roundtables (MDER), beginning in Beijing and continuing through the year in Brussels and Suzhou.
The summits were aimed at fostering cooperation between the two continents and increasing quality and safety. Cooperation is critical for both sides, as China is the EU’s second-largest trading partner and the EU is China’s largest trading partner.
The groups encouraged to play nicely included China’s General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ) and State Food and Drug Administration (SFDA) and the European Commission Directorate-General for Industry and Enterprise (ECDGIE).
Medical device industry associations, testing institutes and academia also joined the party to analyze European and Chinese regulatory frameworks. Attendees then applied the principles of the Global Harmonization Task Force (GHTF), comprised of medical device regulatory authorities to facilitate international trade and encourage quality and effectiveness, to hammer out the Joint Working Group Report.
The report included recommendations on conformity assessment, quality management systems (QMS), product certification, adopting international standards, implementing risk management and refurbishing electromedical equipment.