GB9706.1:2020 - in-country testing

RA_QA_Expert

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Dear colleagues,

The Electrical Standards GB9706.1:2020 (same as IEC 60601-1:2012) etc. will be implemented on May 1st, 2023 in China.
According to the current regulations, does a foreign manufacturer need to perform in-country testing for all medical devices (where these standards are applicable) before May 1st, 2023 OR is it possible to replace in-country testing by independed certification (e.g. from TUV, UL,...)? Is May 1st, 2023 final deadline or any additional transition period for compliance exists?

Thank you for your help.
 
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