Medical device labeling refers to the medical device or its packaging attached to the identification of product features and indicate the safety warning information such as text description and graphics, symbols. Article IV medical device instructions and labeling content should be scientific, true, complete and accurate, and consistent with the product characteristics.
Medical device instructions and labeling content should be consistent with the registered or filed by the relevant content.
Medical device labeling content should be consistent with the relevant content of the manual. Article medical device instructions and labels on the name of the disease, professional terminology, diagnosis and treatment process and the results of the expression, should be used in the national unity or standardized special vocabulary, unit of measurement should be consistent with the provisions of the relevant national standards. Article VI medical device instructions and labels used in the symbols or identifying colors should be consistent with the provisions of relevant national standards; no relevant standards, the symbols and identifying colors should be described in the instructions. Article VII of medical devices should be attached to the minimum unit of sale instructions.
The user of medical devices should be in accordance with the instructions for the use of medical devices. Article VIII of the product name of medical devices should be used in the common name, the common name should be consistent with the State Food and Drug Administration of the medical device naming rules. Class II, Class III medical device product name should be consistent with the product name in the medical device registration certificate.
Product name should be clearly marked in the instructions and labels in a prominent position. Article IX medical device instructions and labels should be used in Chinese, the use of Chinese should be consistent with the national common language and writing standards. Medical device instructions and labels can be attached to other languages, but should be expressed in Chinese shall prevail.
Medical device instructions and labels in the text, symbols, tables, figures, graphics, etc. should be accurate, clear and standardized. Article X medical device instructions should generally include the following:
(a) product name, model, specifications;
(b) the name of the registrant or filer, residence, contact information and after-sales service units, imported medical devices should also contain the name of the agent, residence and contact information;
(c) the name of the manufacturer, residence, production address (C) the name, residence, production address, contact information and production license number or production record certificate number, commissioned production should also be marked with the name of the commissioned enterprise, residence, production address, production license number or production record certificate number;
(D) the medical device registration number or record certificate number;
(E) the number of the product's technical requirements;
(F) the performance of the product
(vii) contraindications, precautions, warnings and tips;
(viii) installation and use instructions or diagrams, by the consumer's own personal use of medical devices should also have a safe use of the special instructions;
(ix) product maintenance and maintenance methods, special storage, transportation conditions, methods
(j) the date of manufacture, use or expiration date;
(k) a list of accessories, including accessories, accessories, wear and tear replacement cycle and replacement method instructions;
(l) medical device labeling used in the graphic, symbols, abbreviations and other content of the explanation;
(m) the preparation of the manual or date of revision;
(n) the date of preparation or revision;
(o) the medical device labeling;
(p) the medical device labeling;
(p) the medical device labeling /p>
(xiv) other content should be labeled. Article XI of the medical device instructions on the precautions, warnings, and suggestive content mainly includes:
(1) the object of the product use;
(2) potential safety hazards and restrictions on the use of the product;
(3) product in the process of the correct use of the product in the event of an accident, the operator, the user's protective measures as well as emergency and corrective measures should be taken;
(4) the product should be labeled with the date of preparation or revision;
(xiv) other content should be labeled. p>
(d) the necessary monitoring, assessment, control means;
(e) single-use products should indicate the "single-use" words or symbols, has been sterilized products should indicate the sterilization method as well as sterilization packaging damage to the treatment method, the need to disinfect or sterilize the use of disinfection or sterilization methods should be described;
(G) in the process of use, and other products may produce mutual interference and its possible hazards;
(H) the use of the product may be brought about by adverse events or the product components may cause side effects. Product components contained in the composition of the components or auxiliary materials that may cause side effects;
(ix) medical device waste disposal should pay attention to matters that need to be dealt with after the use of the product, it should be indicated that the corresponding treatment method;
(x) according to the characteristics of the product, should prompt the operator, the user to pay attention to other matters.