China mandated electrical medical device manufacturers to comply with its national mandatory standard GB 9706.1-2007, equivalent to IEC 60601-1 Edition 2, since 2008. Even though overseas manufacturers adopted IEC 60601-1 Edition 3.1 in 2012, China remained at IEC 60601-1 Edition 2. The result of such a long-time delay in adopting the latest standard is increased cost and time delays for manufacturers. If overseas electrical medical device manufacturers do not have Edition 2 reports for China, they will need to repeat the entire IEC 60601-1 Edition 2 tests in China. If they do have 3rd party Edition 2 reports, they only need to do a subset of the tests locally.
On April 9, 2020, NMPA and Standardization Administration of the People’s Republic of China (SAC) jointly published GB 9706.1:2020, which is equivalent to Edition 3.1 of IEC 60601-1. The implementation date will be May 1, 2023.
GB 9706.1:2020 has undergone major changes compared to GB 9706.1-2007:
Over the years, China regulatory authorities have made enormous efforts to catch up with international electrical safety standards but has always been lagging behind the revisions of its international counterparts.
In 1983, the Technical Committee 10 (TC 10, same role as SC62A of TC62 in IEC) published General Safety Requirements for Medical Electrical Equipment based on IEC 601-1:1977. The corresponding China national standard is GB 9706.1-88, equivalent to IEC 60601-1:1977/Amendment 1, was issued in 1985 for the first time in China
The next version, GB 9706.1-1995, became effective on December 1, 1996. It was equivalent to IEC 60601-1:1988/Amendment 1. The revised GB 9706.1-2007, in equivalence to the IEC 60601-1:1988/ Amendment 2, became effective on July 1, 2008.
For the Edition 3, China Medical Device Standards Management Center has organized relevant parties to incorporate the IEC 60601-1 Edition 3. Then TC10’s revision project was approved in September 2014. However, due to the modification of IEC standard, the publication of China standard delayed accordingly.
GB 9706.1-2020, equivalent to of IEC 60601-1 Edition 3.1, was officially released on April 9, 2020 and will be officially implemented on May 1, 2023.
When implemented, overseas manufacturers need to pay attention to the following:
For an English copy of the GB 9706.1:2020, please email us at info@ChinaMedDevice.com.
We have experienced engineers on-site to help you with type testing or guide you how to incorporate China mandatory technical standards into your design control. We have obtained certificates for many electronical equipment such as:
For more information, please email Info@ChinaMedDevice.com.