Performing technical safety tests is a key step in the procedure for accessing the Chinese device market and is particularly critical in the case of electro-Medical Devices.
This is because tests performed outside the Chinese border and their reports prepared in accordance with the international standard IEC 60601-1 are not recognised when applying for device registration with the NMPA, the Chinese Regulatory Authority that regulates Medical Devices.
For this reason, safety tests must be repeated at a local laboratory specifically designated by the Regulatory Authority and with China Metrology Accreditation (CMA).
In particular, in order to assess the safety of electroMedical Devices, the Regulatory Authority recognises the Chinese standard BG 9706.1-2020, which replaced the previous GB 9706.1-2007 and is similar to the international technical standard IEC 60601-1 III ed.
The Chinese standard published in 2020 will become fully effective on 1 May 2023.
Which features of the 2020 version?
Compared to its 2007 predecessor, the Chinese standard BG 9706.1-2020 has numerous adjustments and additions such as:
- Extension of the scope of electrical safety audits;
- Introduction of essential performance requirements;
- Introduction of the expected lifespan;
- Obligation of risk management throughout the product life cycle;
- Greater focus on mechanical safety: means of protection for operators and patients (MOOPs and MOPPs), modification of electrical shock protection requirements and additional fire protection requirements;
- Inclusion of requirements in standards GB 9706.15 (IEC 60601-1-1 on medical systems) and YY 07708 (IEC 60601-1-4 on alarms), which will be removed with the implementation of GB 9706.1:2020.
Consequences for Manufacturers
Because of the transition period of the standard, the scenarios that might occur for foreign manufacturers are different.
- Scenario 1 – entry into force and implementation of the GB 9706.1-2020 standard during the first registration or amendment. Manufacturers must submit the test report according to the new standard or, for prudence’s sake, two tests are carried out according to the old and the new standard.
- Scenario 2 – entry into force and implementation of the GB 9706.1-2020 standard being renewed. If the manufacturer has made substantial changes to the device in order to comply with the mandatory update of the standard, such as the replacement of critical components, the already issued certificate should first be amended and then the renewal procedure undertaken. In the case of non-substantial changes, on the other hand, a rationale can be provided to justify and adapt to the new standard.
The NMPA frequently issues or updates standards on Medical Devices and the procedures for qualified and recognised testing are very long, sometimes even reaching 12 months. Since IMDRC certificates issued at the end of registration last for 5 years, it is recommended that manufacturers inform themselves and start the testing procedures according to the standard BG 9706.1-2020 well in advance.
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