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According to the "Regulations on the Management of Labels in Medical Device Instructions", medical device labels refer to text descriptions, graphics, and symbols attached to medical devices or their packages that are used to identify product features, indicate safety warnings, and other information. The text content of the medical device instruction label should be in the language. The use should comply with the common language and character standards of the family. The language of the medical device instruction label should be accurate.
Medical device instruction label text, symbols, tables, numbers, graphics etc. should be accurate, clear and standardized
Article 13 Medical device labels should generally include:
() product name, model, specifications;
( 2) Registered or filed name, address, and contact information. Imported medical devices should indicate the agent’s name, address, and contact information;
(3) Medical device registration certificate number or filing certificate number;
(4) The name, residence, property address, contact information and production license number or production registration certificate number of the production enterprise shall be marked with the name, residence, production address, production license number or production registration certificate number of the entrusted company;
(5) Production period, use period or expiration date;
(6) Power connection conditions and input power;
(7) Graphics should be marked according to product characteristics , symbols and related content;
(8) Necessary warnings and precautions;
(9) Special storage, operating conditions or instructions;
(10) ) The labels of medical devices that are used to damage the environment or have negative effects should include warning signs or written warning instructions;
(10) The labels of medical devices with radiation or radiation should include warning signs or written warning instructions
The position of the medical device label or the restricted content must be marked with at least the product name, model, specification, production period, use period or expiration date, and the label must clearly indicate its content. Please refer to the instructions for details
Article 14 Contents of the medical device instruction label:
() Contains efficacy assertions or guarantees such as good efficacy, guaranteed cure, complete cure, radical cure, immediate effect, complete toxic and side effects, etc.;
(2) ) Contains absolute language expressions such as high technology, science, advanced, and excellent;
(3) Explain the cure rate or efficiency;
(4) Compare the efficacy and safety of its company's products ;
(5) Containing language of promises such as insurance and effective refunds from insurance companies;
(6) Using any unit, name or image to prove or recommend;
(7) Containing misleading statements that may cause someone to already suffer from a certain disease or misunderstand the use of the medical device to cause a certain disease or aggravate the condition and its false, exaggerated or misleading content;
(8) ) The content is prohibited by laws and regulations