Designation of Shitei Yakubutsu (designated substances), based on the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (hereinafter referred to as the Act). (1960, Law No.145); (1 page(s), in English)

National Standard of the P.R.C., Medical electrical equipment –Part 2-71: Particular requirements for the basic safety and essential performance of functional near-infrared spectroscopy (NIRS) equipment; (32 page(s), in Chinese)

Notice of Proposed Rulemaking and Announcement of Public Hearing: Amendments to Article 6, Clear and Reasonable Warnings Safe Harbor Methods and Content; (9 page(s), in English)