{"id":21076,"date":"2022-06-21T17:52:56","date_gmt":"2022-06-21T15:52:56","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=21076"},"modified":"2022-07-25T15:34:37","modified_gmt":"2022-07-25T13:34:37","slug":"china-updated-safety-standard-for-electromedical-devices","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2022\/06\/21\/china-updated-safety-standard-for-electromedical-devices\/","title":{"rendered":"CHINA: updated safety standard for electromedical devices"},"content":{"rendered":"\r\n
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Performing technical safety tests<\/strong> is a key step in the procedure for accessing the Chinese device market and is particularly critical in the case of electro-medical devices.<\/p>\r\n\r\n\r\n\r\n

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<\/strong> when applying for device registration with the NMPA, the Chinese Regulatory Authority that regulates medical devices.<\/p>\r\n\r\n\r\n\r\n

For this reason, safety tests must be repeated at a local laboratory<\/strong> specifically designated by the Regulatory Authority and with China Metrology Accreditation (CMA).<\/p>\r\n\r\n\r\n\r\n

In particular, in order to assess the safety of electromedical devices, the Regulatory Authority recognises the Chinese standard BG 9706.1-2020<\/strong>, which replaced the previous GB 9706.1-2007 and is similar to the international technical standard IEC 60601-1 III ed.<\/p>\r\n\r\n\r\n\r\n

The Chinese standard published in 2020 will become fully effective on 1 May 2023.<\/p>\r\n\r\n\r\n\r\n

Which features of the 2020 version?
<\/em><\/strong><\/h2>\r\n\r\n\r\n\r\n

Compared to its 2007 predecessor, the Chinese standard BG 9706.1-2020 has numerous adjustments and additions such as:<\/p>\r\n\r\n\r\n\r\n