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.
What’s New
GB 9706.1:2020 has undergone major changes compared to GB 9706.1-2007:
- Expand the scope of Electrical Safety
- Introduce requirements of Essential Performance
- Introduce requirements of Expected Service Life
- Mandate Risk Management throughout the product life cycle. Require risk-based safety management rather than testing-based management
- Pay more attention to mechanical safety, providing different means of operators and patients protections (MOOP and MOPP), modifying electric shock protection requirements, and adding fire protection requirements
- Incorporate the requirements of GB 9706.15 (IEC 60601-1-1) and YY 0708 (IEC 60601-1-4), which are to be abolished when GB 9706.1:2020 takes effect
Transforming GB 9706.1-88 into GB 9706.1:2020
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.
Key Takeaways for Foreign Manufacturers
When implemented, overseas manufacturers need to pay attention to the following:
- The GB 9706.1-2020 is in line with the IEC 60601-1 Edition 3.1 which is accepted worldwide
- No longer need to consider the requirements of the IEC 60601-1 Edition 2 in the R & D phase and verification and validation stages
- More documents need to be provided in type testing
- Third parties produced reports, such as those from UL, CSA, TÜV and VDE, might be recognized by 2023.
Key Takeaways for China Domestic Manufacturers
- There is no significant impact for domestic manufacturers that export abroad and are already implementing the IEC 60601-1 Edition 3.1
- The impact is greater for domestic manufacturers that implement GB 9706.1-2007. It will take considerable time and cost to rebuild the risk management system, and the modification of the product design might be needed.
For an English copy of the GB 9706.1:2020, please email us at info@ChinaMedDevice.com.
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