Draft amendments to the Requirements for the implementation, maintenance and evaluation of the quality management system of medical devices, depending on the potential risk of their use; (2 page(s), in Russian)

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)

Key Points and Judgment Principles of GMP Inspection for Cosmetics (Draft); (34 page(s), in Chinese)