Regulation for Registration of Medical Devices Article 36

Publication of medical device instruction leaflet, labeling and packaging, in addition to conformity with Article 75 of the Act and related proclamations made by the central health competent authority, applicant shall modify, supplement or resend related documents under the request of central health competent authority.Medical device instruction leaflet shall publicize all contraindication, warning, side effects, and other notices, in red, red box, or bold type fonts. Font type in a Chinese instruction leaflet shall not be smaller than 7-pt font.Domestic medical device labeling, instruction leaflet, and packaging shall mainly publicize in Chinese characters. Characters in any other language shall be smaller than Chinese ones.For imported medical device, in addition to mandatary Chinese instruction leaflet, labeling and packaging shall publicize product name, medical device permit license number, the name and address of the pharmaceutical firm as the importer shall all be in Chinese characters. Manufacturing date and expiration date shall be in Chinese characters as well, or understood habitually; Characters in any other language shall be smaller than Chinese ones.