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.

The product name of a medical device shall comply with the following regulations:
1.A product name shall not use pharmaceutical name, trademark, or name of manufacturer from others, unless trademark awarded or authorization obtained.
2.A product name shall not be the same as other medical device, or involved in counterfeiting or insinuation.
3.Product name shall not involve in misrepresentation, overstatement, or leading people in improper association with medical device and/or efficacy.
4.Chinese product name shall not contain any character in any other language or in numbers, unless phrases used contain meaning directly related, or English trademarks contains special meaning and approved by the central health competent authority.
5.The Chinese and English names of medical devices exclusively for export shall not be the same as those of domestically manufactured medical devices.
6.A product name shall not be in other improper situations as a name of medical device.
The precedence of medical device names that are identical or similar shall be determined on the basis of the precedence of trademarks, company names, or other identifiable names.
The central health competent authority may review the name of a medical device already approved for sale in accordance with regulations of the foregoing two paragraphs.

This Regulation takes effect starting from the date of promulgation.