National Standard of the P.R.C., Medical Electrical Equipment-Part 2-55:Particular Requirements for the Basic Safety and Essential Performance of Respiratory Gas Monitors; (48 page(s), in Chinese)
Regulations, No.: DFAR/HMDAR/TRG/002 Rev_2, Governing Registration of Medical Devices including In Vitro Diagnostics; (13 page(s), in English)
Draft resolution 1305, 27 December 2024; (281 page(s), in Portuguese)
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