The IEC 60601 series of standards determine requirements to safety and performance of active medical devices. The third edition of the parent standard IEC 60601-1was presented by the IEC in 2005 and adopted as EN 60601-1:2006 in the European Union (EU), medical device certification according to the third edition became mandatory in 2012.

In China, IEC 60601 standards are adopted as National Standards GB 9706. The ‘General requirements for basic safety and essential performance’ (GB 9706.1) together with the first batch of collateral and particular standards were published in April 2020 and will come into force on 01. May 2023.

While harmonisation of the standard versions in China and Europe is good news for the industry, the transition from edition two to edition three poses considerable challenges, especially in maintaining existing registrations.

To provide medical device manufacturers, an overview about the imminent changes and address the most urgent challenges, COCIR China, in cooperation with the Liaoning Medical Device Test (LMTI), the EU SME Centre in China and the EU Chamber of Commerce in China hold this seminar.

Agenda

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