China medical device standards 2020

In 2020, China issued 24 national standards for medical devices and 125 industrial standards for medical devices. As of December 31, 2020, there are 1758 standards for medical devices. 226 national standards (92 compulsory and 134 recommended standards), 1532 industrial standards (305 compulsory and 1227 recommended standards) Among the current effective medical device standards, there are 286 basic standards, accounting for 16%; 54 management standards, accounting for 3%; 422 method standards, accounting for 24%; and 996 product standards, accounting for 57%. The current effective standards of medical devices are mainly classified between medical device integration (C30) and medical hygiene productsRead More →

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