Electrical medical device manufacturers have been mandated by the NMPA to comply with its national standard, GB 9706.1-2007, analogous to IEC 60601-1 Edition 2 while the new version, IEC 60601-1 Edition 3.1 has been published and adopted by other countries since 2005.
A portion of the delay was because the new version of standards did not fit well with the large volumes involved in China’s medical device industry. The major contributing factor to the significantly long delay was the conversion of the IEC standards into Chinese standards. Chinese standards are given either the prefix YY or GB depending on a variety of factors and regulatory requirements.
Certain clauses contained in the new IEC 60601-1 version did not relate to testing and would be out of the scope of NMPA test centers, which is the only way to validate whether the medical product fulfills the requirements. These differences contributed to delays in the adoption of IEC 60601-1, edition 3.1.
IEC 60601-1, Edition 3.1 Adopted:
The adoption of IEC 60601-1 Edition 3.1 by the NMPA and Standardization Administration of the People’s Republic of China (SAC) resulted in the publication of new standard, GB 9706.1:2020 on April 9, 2020. The new standard will have a three-year transition period and will be implemented on May 1, 2023.
2020 New changes:
- Expansion of Electrical Safety scope
- Introduction of Essential Performance requirements
- Introduction of Expected Service Life requirements
- Mandated Risk Management throughout the product life cycle requiring risk-based safety management instead of testing-based management
- More focus on mechanical safety: means of operators and patient protections (MOOP and MOPP), modification of electric shock protection requirements, and additional fire protection requirements
- Incorporation of GB 9706.15 (IEC 60601-1-1) and YY 07708 (IEC 60601-1-4) requirements, which will be eliminated upon the implementation of GB 9706.1:2020
The implementation of GB 9706.1:2020 may have a greater impact for Chinese domestic manufacturers that complies to GB 9706.1-2007 as they navigate the changes, but not for foreign manufacturers and Chinese domestic manufacturers that export abroad and are already complying to IEC 6060101 edition 3.1.
About Global Regulatory Partners:
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices and pharmaceutical companies globally. GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and Argentina. GRP helps many life science companies register their products in different countries in compliance with local regulations.
GRP videos. Registration of Medical Devices in China.