Application Process and Requirements for Post-Approval Changes of Biological Products Adopting the World Health Organization Guidelines for Changes to Approved Vaccines and Biotherapeutic Products for Human Use; (91 page(s), in English)

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)

Resolution – RDC number 644, 24 March 2022; (2 page(s), in Portuguese)