GB9706.1:2020 - in-country testing

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.

RA_QA_Expert said:

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.

Click to expand...

1.Yes the new GB standards will be effective since May.1.2023 in China
2.You can still perform in-country testing with current standards before May.1.2023 in China. attention, you must submit the NMPA registration before May.1, after this deadline, even you already performed the test and got the report, there has no way.
3.local competent authority doesn't recognize the other certification like you mentioned.
4.Yes it is deadline, current is transition period.

TimZhao said:

1.Yes the new GB standards will be effective since May.1.2023 in China
2.You can still perform in-country testing with current standards before May.1.2023 in China. attention, you must submit the NMPA registration before May.1, after this deadline, even you already performed the test and got the report, there has no way.
3.local competent authority doesn't recognize the other certification like you mentioned.
4.Yes it is deadline, current is transition period.

Click to expand...

现在看看说法不一定对吧

dingyi said:

现在看看说法不一定对吧

Click to expand...

Yes. official announcement hasn't updated yet. highly probably shift another two years for transition.