As previously announced, technical safety tests are a key component of the registration process for Medical Devices in China. In this regard, on 18th November, the Chinese Regulatory Authority NMPA (National Medical Product Administration) published an update No. 42 dated 10/11/2022 on safety standards for electroMedical Devices, which includes a list of Medical Devices on which the recent update will have an impact in the current year.
As previously announced, technical safety tests are a key component of the registration process for Medical Devices in China. In this regard, on 18th November, the Chinese Regulatory Authority NMPA (National Medical Product Administration) published an update No. 42 dated 10/11/2022 on safety standards for electroMedical Devices, which includes a list of Medical Devices on which the recent update will have an impact in the current year.
NMPA has announced that the new Chinese standard on the safety of electroMedical Devices BG 9706.1-2020, similar to IEC 60601-1 (International Standard for Basic Safety and Essential Performance of Electromedical Equipment) will enter into force on 1st May 2023. This standard includes more significant changes from the point of view of mechanical safety, requirements for protection against fire and electric shock, risk management and expansion of the scope of safety audits.
The new requirements have different implementation dates: depending on the specific update, manufacturers of Medical Devices will have to submit a change notification to demonstrate compliance with the new requirements before submitting the renewal application. Previously, however, any changes could be communicated within the same IMDRC (Import Medical Device Registration Certificate) renewal application.
It is therefore of paramount importance that manufacturers take into account the extended timeframe of the renewal process (up to 12 months) and ensure that they have all the updated documentation to demonstrate compliance in a timely manner and continue to have uninterrupted access to the Chinese market. If you do not comply with the new standards, you could risk having your devices seized, so NMPA encourages Manufacturers to conduct internal inspections to ensure their devices comply with GB 9706.1-2020.
The process of compliance with the new electro-medical safety standards can be divided into three steps:
- Update the technical requirements of the product from GB 9706.1-2007 to GB 9706.1-2020;
- Import and test the device in China according to the new GB 9706.1-2020 standard;
- Submit a request for change of registration information to NMPA by the China Agent of IMDRC, including valid and qualified test reports.
NMPA periodically releases new standards for Medical Devices and it is therefore imperative that Manufacturers who market or intend to market their devices in the Chinese market are always kept up-to-date on changes to the standards so that they can act promptly. In addition, as several Manufacturers have already reported, products not tested according to the new standards will not be renewed by the NMPA until valid test reports are submitted, thus causing problems with interruption of marketing in the Chinese market.
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Sources: https://www.cmde.org.cn/xwdt/zxyw/20221118133123194.html
http://app.nifdc.org.cn/biaogzx/qxqwk.do?formAction=list&istiaojian=1
