China: Implementation of Electrical Safety Standards for Medical Devices

In February of 2020, China released a new update on all the medical electrical equipment with new safety standards in China-specific that will take effect on 1 May 2023. All requirements on the basic safety and essential performance are to be enforced on new and renewal applications of registered devices, which include those already issued an Imported Medical Device Registration Certificate (IMDRC) as well as those that are currently in the China market. It is urged for all manufacturers with electromedical devices to start generating qualified test certificates and amend the existing IMDRC for a smooth transition into China market.

China has its independent standards and regulatory system such that product testing must be done according to specific products’ technical requirements. All testing should be done concerning all related Chinese GB (National Standard) and YY (Industrial standards) standards. It is very critical to identify applicable standards to work with a preferable laboratory for product testing requirements in China.

Steps To Ensure Market Access for Electromedical Devices

As of now, all electromedical devices with active IMDRC have been tested with the previous standard of GB 9706.1-2007. After the new regulation, all will need to be re-tested for the new compulsory standard GB 9706.1-2020.

From 1 May 2023, existing IMDRC will be subjected to spot checks for conformance to GB 9706.1-2020. Those who are found to be out of compliance will face punishment. Furthermore, for devices that have not updated their EMC testing, the IMDRC renewal process may be complex, and a new registration application may be required.

Additional Updated Standards

All manufacturers of non-electromedical equipment should also review the updated Chinese standards to ensure compliance. Some standards may have been released within the validity of 5 years for International Medical Device Registration Certificate (IMDRC) and may not meet the new updated standard’s requirements during renewal. Manufacturers should take note and start their testing at least a year ahead before renewing.

Source:

Chinese Standards.net (Click on Full PDF to view)

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