Technical testing is an integral component of the medical device registration process in China. In October 2022, the China NMPA announced that the new Chinese standard related to the safety of electric medical devices – BG 9706.1-2020 – will come into effect on May 1, 2023. This new standard is similar to IEC 60601-1, which is the international standard for Basic Safety and Essential Performance of Medical Electrical Equipment.
The new standard contains 76 changes compared to the previous version issued in 2007. These changes include a more significant emphasis on mechanical safety, protection requirements with respect to electrical fire and shock, risk management, and broaden the scope of safety audits.
Products that are manufactured after May 1, 2023 need to meet these new testing requirements. Applicants that fail to comply with the new standards will be penalized and risk having their products seized. The NMPA also encourages applicants to conduct internal inspections to ensure their products are compliant with GB 9706.1-2020.