Draft Amendments to Article 7 and to the Annex to Article 4 of the "Regulations Governing the Classification of Medical Devices"; (43 page(s), in English), (27 page(s), in Chinese)

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)

Draft Commission Delegated Regulation amending Regulation (EC) No 1272/2008 of the European Parliament and of the Council as regards the harmonised classification and labelling of certain substances; (7 page(s), in English), (16 page(s), in English)