Medical device instructions, labels and packaging marking regulations

Article I In order to standardize the medical device instructions, labels and packaging identification, to ensure the safety of medical devices, according to the "supervision and management of medical devices regulations", the formulation of these provisions. Article 2 Where the Chinese people *** and the territory of the sale, use of medical devices should be in accordance with the requirements of this provision with instructions, labels and packaging identification. Simple and easy to use products, in accordance with the provisions of the State Food and Drug Administration, can be omitted from the instructions, labels and packaging identification of one or two of the three, in accordance with its provisions. Article III users of medical devices should be in accordance with the instructions for the use of medical devices. Article IV medical device instruction manual refers to the production of the enterprise and with the product provided to the user, can cover the product safety and effective basic information and to guide the correct installation, commissioning, operation, use, maintenance, repair of technical documents.

Medical device labeling refers to the medical device or packaging attached, used to identify the characteristics of the product text description and graphics, symbols.

Medical device package labeling refers to the packaging marked to reflect the main technical characteristics of the medical device text description and graphics, symbols. Article V medical device instructions, labels and packaging identification of the content should be true, complete, accurate, scientific, and consistent with the product characteristics.

Medical device labeling, packaging and identification of the content should be consistent with the relevant content of the manual. Article VI medical device instructions, labels and packaging identification text content must be used in Chinese, can be attached to other languages. The use of Chinese should be consistent with the national common language and writing standards.

Medical device instructions, labels and packaging identification of text, symbols, graphics, tables, figures, photos, pictures, etc. should be accurate, clear and standardized. Article VII of the medical device instructions should be consistent with national standards or industry standards relevant requirements, generally should include the following:

(a) product name, model, specifications;

(b) the name of the manufacturer, registered address, production address, contact information and after-sales service units;

(c) "Medical Device Manufacturer License" number (except for the first class of medical devices), the medical device registration unit. (except for Class I medical devices), medical device registration certificate number;

(D) product standard number;

(E) product performance, main structure, scope of application;

(F) contraindications, precautions, and other need for warning or prompt content;

(G) medical device labeling used in the graphic, symbols, abbreviations, and other content of the explanation;

(h) installation and use instructions or diagrams;

(ix) product maintenance and maintenance methods, special storage conditions, methods;

(j) limited use of the product, should be marked with the expiration date;

(k) product standards should be marked in the instructions of the other content. Article VIII of the medical device labeling, packaging identification shall generally include the following:

(a) product name, model, specifications;

(b) the name of the manufacturer, registered address, production address, contact information;

(d) product standard number;

(e) product Production date or batch (editing) number;

(F) power connection conditions, input power;

(VII) limited use of the product, the expiration date should be marked;

(VIII) based on the characteristics of the product should be marked graphs, symbols and other relevant content. Article IX of medical devices instructions, labels and packaging identification shall not have the following content:

(a) contains "the best efficacy", "guaranteed cure", "cure", "cure", "instant effect", "no toxic side effects" and other assertions or guarantees of efficacy;

(ii) contains the "highest technology", "the most advanced technology", "the most advanced technology", "the most advanced technology", "the most advanced technology", "the most advanced technology" and "the most advanced technology", "the most advanced technology". "The highest technology", "the most scientific", "the most advanced", "the best" and other absolutist language and expression;

(d) compared with the efficacy and safety of other companies' products;

(e) contains "insurance company insurance", "ineffective refunds" and other promising language;

(f) the "highest technology", "the most scientific", "the most advanced", "the best", etc. Language;

(F) the use of any unit or individual's name, image as a proof or recommendation;

(G) contains make people feel that has been suffering from a disease, or make people misunderstand that do not use the medical device will suffer from a disease or aggravation of the expression;

(VIII) laws and regulations prohibit other content. Article 10 The product name of medical devices should be consistent with the corresponding national standards and regulations. Article XI of medical devices should be clearly marked in the instructions, labels and packaging identification of the product name in a prominent position, and with the certificate of registration of medical devices in the product name. Article XII of medical devices have a trade name, instructions, labels and packaging identification can be marked in the same trade name, but should be consistent with the medical device registration certificate marked in the trade name. Simultaneous labeling of the product name and trade name, should be divided into lines, shall not be hyphenated, and the text of the trade name of the medical device shall not be greater than twice the text of the product name.

Medical device trade names shall not be used to exaggerate, assert the efficacy of the product absolute terms, shall not violate other laws and regulations. Article XIII of the medical device instructions on the precautions, warnings, and suggestive content mainly includes:

(a) the use of the product may bring side effects;

(b) the correct use of the product in the process of accident, the operator, the user's protective measures and emergency and corrective measures that should be taken;

(D) has been sterilized products should indicate the sterilization method, indicate the word "sterilized" or mark, and indicate the treatment of damage to the sterilization package;

(E) use (E) the need for disinfection or sterilization before use should indicate the method of disinfection or sterilization;

(F) the product needs to be installed with other products or coordinated operation, it should be specified with the use of the requirements;

(VII) in the process of use, and other products that may produce mutual interference and its possible dangers;

(VIII) the product needs to be processed after use, it should indicate the corresponding processing method. Should indicate the appropriate method of treatment;

(ix) according to the characteristics of the product, the operator should be prompted to pay attention to other matters, the user.