(July 8, 2004 the State food and Drug Administration announced come into force on the date of promulgation, 10th) first to standardize medical device brochures, labels, and packaging, guarantee the safety of medical devices used, under the supervision and administration of medical devices Ordinance, these rules are formulated. Article in the People's Republic of China territory, the use of medical devices should be in accordance with the requirements of this provision include directions, labels, and packaging.
    Easy to use product, according to the State food and drug administration regulations, you can omit the instructions, labels and packaging one or two of the three items, in accordance with its provisions.
    Article the users of medical devices should be used in accordance with the manual of medical devices medical devices.
    Fourth manual is produced by the manufacturer of medical devices and products made available to users, covers the basic information and to guide the correct product is safe and effective installation, commissioning, operation, use, maintenance, maintenance of technical documentation.
    Refers to a medical device or medical device label on the package is attached, used to identify text descriptions of product features, graphics and symbols.
    Mark on the packing label of medical devices is in the packaging reflects the medical device main technical features of the text descriptions, graphics, symbols.
    Article fifth medical device brochures, labels and packaging shall be true, complete, accurate and scientific, and consistent with the product characteristics.
    Content of the medical device label and package labeling should be compatible with the instructions about the content. Article sixth medical equipment manuals, labels and packaging label text must use Chinese, can be attached to other languages.
    Chinese written language in common use shall conform to the national standard.
    Medical equipment manuals, labels and packaging label text, symbols, graphics, tables, figures, photos, pictures and so on should be accurate, clear, standardized. Seventh article medical devices manual should meet national standards or industry standard about requirements, General should including following content: (a) products name, and model, and specifications; (ii) production Enterprise name, and registered address, and production address, and contact way and the after-sales service units; (three) medical devices production enterprise license number (first class medical devices except), and medical devices registered certificate number; (four) products standard number; (five) products of performance, and main structure, and applies range; (six) taboo syndrome, and
    Note matters and other need warning or tips of content; (seven) medical devices label by with of graphics, and symbol, and abbreviations, content of explained; (eight) installation and using description or diagram; (nine) products maintenance and maintenance method, special store conditions, and method; (10) deadline using of products, should marked effective term; (11) products standard in the provides of should in manual in the marked of other content. Eighth article medical devices label, and packaging identifies General should including following content: (a) products name, and model, and specifications; (ii) production Enterprise name, and registered address, and production address, and contact way; (three) medical devices registered certificate number; (four) products standard number; (five) products production date or batch (series),; (six) power connection conditions, and entered power; (seven) deadline using of products, should marked effective term; (eight) according to products characteristics should mark of graphics, and symbol and other related within
    Capacity. Nineth article medical devices manual, and label and packaging identifies shall not has following content: (a) contains "effect best", and "guarantee cure", and "package rule", and "radical", and "immediately worked", and "completely nontoxic side effects", said effect of assertions or guarantee of; (ii) contains "highest technology", and "most science", and "most advanced", and "best", absolute language and said of; (three) description cure rate or has efficiency of; (four) and other enterprise products of effect and security phase compared of; (five) contains
    "Insurance company insurance", and "invalid refund", commitment sex language of; (six) using any units or personal of name, and image for proved or recommended of; (seven) contains makes people was has patient a species disease, or makes people misunderstanding not using the medical devices will patient a species disease or aggravated illness of expressed of; (eight) legal, and regulations provides ban of other content.
    Article tenth name of medical devices shall conform to the national standards and regulations.
    11th medical device product name should be clearly indicated in the instructions, labels, and packaging label prominently, and consistent with the product name in the registration certificate of medical devices. 12th medical device trade names, also in the instructions, labels, and packaging identity marking product name, but should work with mark in the registration certificate of medical devices product line.
    While marking product name and product name, branch, no ligatures, and medical device product name shall not be greater than the product name text twice.
    Medical device trade names shall not be used in exaggerated, asserting absolute terms of the efficacy of the product, shall not violate the provisions of other laws and regulations. 13th article medical devices manual in the about note matters, and warning and tips sex content main including: (a) products using may brings of side effects; (ii) products in right using process in the appeared accident Shi, on operation who, and using who of protection measures and should take of emergency and corrected measures; (three) one-time using products should indicate "one-time using" words or symbol; (four) has sterilization products should indicate sterilization way, indicate "has sterilization" words or mark, And indicate sterilization packaging damaged Hou of processing method; (five) using Qian need disinfection or sterilization of should description disinfection or sterilization of method; (six) products need with other products with installation or collaborative operation Shi, should indicate tie using of requirements; (seven) in using process in the, and other products may produced of mutual interference and may appeared of risk; (eight) products using Hou need processing of, should indicate corresponding of processing method; (nine) according to products characteristics, should tips operation who, and
    Users ' attention to other matters.
    Installation details in the article 14th medical devices should be able to guarantee the operator, using the correct installation, shall include: (a) the product installation instructions and technical diagrams, circuit diagrams, (ii) product is installed correctly and the necessary environmental conditions and identify technology information is correctly installed, and (iii) other special installation requirements.
    15th medical apparatus and instructions by the manufacturer at the time of application for medical device registration, in accordance with the provisions of the medical device registration regulation submission (food) review the drug regulatory agency, submitted by the medical device instructions should be consistent with other registration materials.
    16th production enterprise of medical devices should be content authenticity, integrity, responsibility.
    17th section (food) drug supervision and management departments registration of details in the review of medical devices are not allowed to change.
    18th change details in the article relates to the measures for the administration of registration of medical devices under the circumstances that warrant the re-registration of medical devices, shall not be changed according to the instructions. 19th production and enterprise changes the registration of details in the review of medical devices, does not involve technical changes of the product, manufacturers shall submit the relevant documents, to the original examination and approval Department shall inform medical device registration.
    Related documents include at least: (a) certified copies of the manual review, for the record, (ii) change the filing instructions, (iii) instructions manual changes (including changes to table); (d) register product standard files (limited to the standard text of the manual changes concerning changes); (e) the materials submitted by the authenticity of the statement.
    Original register receipt of the manufacturer of the competent departments to change date of the medical device specification written, does not have different opinions within 20 working days notice in writing, manual changes to take effect, and the competent departments in the original registration shall record; the original registration approval notice in writing within 20 working days, production enterprises shall in accordance with the notice requirements.
    20th article violation this provides, has following behavior one of of, by County above (food) drug supervision management sector give warning, ordered deadline corrected, and remember into production enterprise regulatory archives: (a) unauthorized change by registered review, and record of manual of content of; (ii) listed products of label, and packaging identifies and by registered review, and record of manual content phase against, or violation this provides other requirements of; (three) medical devices of products name or commodity name violation this provides of;
    (D) listing provides instructions, labels, and packaging product is not identified; easy to use product, except as otherwise provided by the State food and drug administration.
    21st medical device manufacturer without proper authorization specification increases the scope of products or indications, or above the county level (food) drug supervision and management departments in accordance with article 35th of the supervision and administration of medical devices Ordinance has not obtained the registration certificate of medical devices will be punished.
    22nd by the State food and Drug Administration is responsible for the interpretation of these provisions. 23rd these provisions come into force on the date of promulgation.
                                                                  On January 4, 2002, issued by the State Drug Administration Manual of medical devices regulations repealed simultaneously.