China NMPA summarized 76 Medical Electrical Standards such as GB 9706.1- 2020, which is equivalent to IEC 60601 -1 Edition 3.1. Finally, China has moved from IEC 60601-1 Edition 2 to IEC 60601-1 Edition 3.1 after 15 years of delay.
The standards have been effective since May 1, 2023. For active medical device manufacturers with existing NMPA certificates, a grace period has been granted to comply by December 31, 2025.
Huge Impact:
If the product has not changed and the referred mandatory standards such as GB or YY standards are updated, the manufacturer needs to do the local type testing first before submitting the modification application. Once the manufacturer obtains the approval in modification on permission items by NMPA, they can do the renewal after.
I have attached the complete list of GB 9706.1-2020 and its parallel Standards. If your products are impacted by the standards updates or have any questions, please email me. Love to hear your feedback especially on risk management part.
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Grace Fu
China Med Device, LLC
MA, U.S.
gpalma@ChinaMedDevice.com
978-390-4453
www.ChinaMedDevice.com
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