{"id":26446,"date":"2023-01-19T17:01:01","date_gmt":"2023-01-19T16:01:01","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=26446"},"modified":"2023-01-20T11:10:54","modified_gmt":"2023-01-20T10:10:54","slug":"china-updated-safety-standards-for-electromedical-devices","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2023\/01\/19\/china-updated-safety-standards-for-electromedical-devices\/","title":{"rendered":"CHINA: updated safety standards for electromedical devices"},"content":{"rendered":"

As previously announced<\/a>, technical safety tests are a key component of the registration process for Medical Devices in China. In this regard, on 18th<\/sup> November, the Chinese Regulatory Authority NMPA (National Medical Product Administration<\/em>) published an update No.<\/a> 42 dated 10\/11\/2022 on safety standards for electromedical devices, which includes a list of Medical Devices<\/a> on which the recent update will have an impact in the current year.<\/h2>\n

As previously announced<\/a>, technical safety tests are a key component of the registration process for Medical Devices in China. In this regard, on 18th<\/sup> November, the Chinese Regulatory Authority NMPA (National Medical Product Administration<\/em>) published an update No.<\/a> 42 dated 10\/11\/2022 on safety standards for electromedical devices, which includes a list of Medical Devices<\/a> on which the recent update will have an impact in the current year.<\/p>\n

NMPA has announced that the new Chinese standard on the safety of electromedical devices BG 9706.1-2020<\/a>, similar to IEC 60601-1 (International Standard for Basic Safety and Essential Performance of Electromedical Equipment) will enter into force on 1st<\/sup> May 2023. This standard includes more significant changes<\/strong> 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.<\/p>\n

The new requirements<\/strong><\/a> 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<\/strong> submitting the renewal application. Previously, however, any changes could be communicated within the same IMDRC (Import Medical Device Registration Certificate<\/em>) renewal application.<\/p>\n

It is therefore of paramount importance<\/strong> that manufacturers take into account the extended timeframe<\/strong> 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<\/strong>. If you do not comply<\/strong> with the new standards, you could risk having your<\/strong> devices seized<\/strong>, so NMPA encourages Manufacturers to conduct internal inspections to ensure their devices comply with GB 9706.1-2020.<\/p>\n

The process of compliance with the new electro-medical safety standards can be divided into three steps<\/strong>:<\/p>\n