Crucial points to consider when implementing a new version of IEC 60601-1:2012 in China

Stephanie (Xing) Huang "We assist clients in China and abroad with high-quality standards, speeding up their market access, and ensuring compliance with local requirements. In our role as China Agent, we separate the regulatory role from the distribution role and manage professionally the pre-market submission and post-market activities."

GB9706.1-2020 (IEC 60601-1:2012 MOD) Medical electrical equipment—Part 1: General requirements for basic safety and essential performance has been implemented in China as of 1st May 2023. The updated Chinese version of IEC 60601-1 is critical to improving the safety and performance of active medical devices marketed in China and increases further alignment with international practice. 

GB9706-related collateral standards have been released, and product-specific standards have been gradually introduced. Until June 2023, 69 new GB9706-related standards have been published, and another seven standards are under revision. Except for two recommended standards (usability and closed-loop controller), the remaining 67 are all mandatory standards.

Some key points that manufacturers should take into account:

  1. Standards naming convention.
    The generic standard is named GB9706.1-2020, collateral standards are named 9706.10X, and product-specific standards are named 9706.20X. 

  2. Grace period applied scenario.
    Since most standards are mandatory, certain grace periods are given to devices. Different timelines apply for the initial application, approved registration, change, and renewal applications. 

Initial new application - Active class II & III medical devices without applicable product-specific standards. The test validation reports to support initial registration shall be ready from 1st May 2023. For an initial application accepted by the NMPA authority before 1st May 2023, the tests performed against the old GB9706.1 could continue to support the registration.  

Approved registration: If GB9706.1 is applicable and/or its product-specific standard implementation date is before 31st December 2025, the test validation may have a 3-year-transition time from the last applicable standard implementation date for class II &III devices and a 2-year-transition time for class I devices. 
For example, if only general GB9706.1-2020 and its collateral standards apply to one approved class III medical device, change application (triggered by the new standard implementation) and test reports complied with GB9706.1-2020 shall be submitted no later than 1st May 2026. Class I shall be filed no later than 1st May 2025 for the same scenario. If there are additional GB9706.1 product-specific standards (implementation date is before 31st December 2025) that also apply to the approved product, the change application shall be applied within three years from the implementation of that specific standard.  

Renewal application: If only a generic GB9706.1-2020 standard is applicable, the new test report shall be ready when submitting the renewal application. 
If an additional product-specific standard is applicable, the test report to support renewal may follow the implementation date of that specific standard. 

  1. Grace period non-applied scenario.
    If additional GB9706.1 related product-specific standards are applicable to the approved products and their implementation dates are after 31st December 2025, the testing shall be performed against all applicable standards since the implementation date. The change application must be submitted to the health authority immediately. 
    For example, if both GB9706.1 and YY 9706.261-2023 Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximetry equipment are applicable, these two standards shall be tested before 15th January 2026 for approved devices. The same policy applies to the initial registration. 

  2. IFU and label update.
    When the product complies with the new standard and the change application with authority has been approved, IFU and label can be updated accordingly. 

  3. Production implementation.
    No grace time is given to the device production compliance. During the transitional time to facilitate the product submission purpose, all the products under manufacturing shall immediately comply with GB9706.1-2020 and its related standards from their implementation date. 

  4. Accredited test labs.
    Sixty-three local laboratories are qualified to carry out the testing against GB9706.1-2020. Suppose the foreign manufacturers who already obtained their test reports based on IEC60601-1:2012 from foreign labs may still have to re-validate the testing locally in China and apply for submission based on the above timeline. The Chinese health authority only accepts reports with CMA (China Metrology Accreditation) accreditation to directly support the registration. Most foreign labs are only ISO17025 qualified, and CB report schemes are not fully qualified for CMA requirements either. The most common practice, for now, is to use the Chinese CMA-accredited labs for re-validation. 

  5. GB9706.1-2020 application IVD products.
    The standard does not apply to IVD products and does not require compliance. Some products are defined as IVD in the EU/US but recognized as medical devices in China; these products shall still follow China medical device GB requirements. 

Key Checklist to prepare the GB9706.1-2020 testing

  • Sample device and its accessories
  • Switching power supply or power adapter. Each model/variant to be tested shall be supplied with one power supply/adapter.
  • Power Transformer. The transformer needs to provide an unpainted sample. If an unrecoverable temperature controller is used inside the transformer, an unpainted sample of N+1 (number of N windings) is required. In other cases, an unpainted sample is required. The insulation level shall be one of ABEF/H. Fuses: Try to choose fuses that comply with 9364.1. If other standards are applicable, they shall specify the 30mi fuse time and current.
  • Insulation case and other external insulation components (damage to which may pose an unacceptable risk)
  • Insulation materials used to support uninsulated grid power components (when their aging may affect safety)
  • Risk management documents
  • Key electrical components. Each key component shall provide a corresponding certificate or test report and datasheet.
  • IFU
  • Usability documentation, when applicable
  • PEMS (Programmable Electrical Medical System) documentation, when applicable 

If you want a list of all the 76 GB-related standards, a copy of accredited local test labs, or have questions about implementation, please contact us for a consultation. 

Want to learn more about Asia-Pacific?
Join us on the 29th of June for a free webinar and Q&A, Medical Device Registration Asia Pacific Part I’. 

More blogs from Stephanie Huang on China's regulatory pathway:

GSPR Adaption to Support China Registration
Update on the Knows and Dos for the innovation pathway
When a clinical study shall be considered in China



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