Article I In order to standardize the content of medical device instructions, to ensure that the user to provide the correct operation methods and product-related information, according to the "supervision and management of medical devices regulations", the formulation of these provisions.
Second, where the Chinese people *** and the territory of the production, sale, use of medical devices should be accompanied by instructions, instructions for medical devices should be in line with the requirements of these provisions.
Article III of the medical device instructions should contain all the information that the product can be used correctly, its content should be true, accurate, scientific, healthy, and consistent with the actual performance of the product. Not in any form to deceive and mislead consumers.
Article IV of the manufacturers of medical devices should be declared instructions stamped and signed by the legal representative, and the authenticity of its contents, is responsible for completeness.
Article V municipal drug supervision and management department is responsible for the administrative region of the production of the first class of medical device instructions for approval; provinces, autonomous regions and municipalities directly under the Central Drug Administration is responsible for the administrative region of the production of the second class of medical devices for approval of instructions; State Drug Administration is responsible for the territory of the production of the third class of medical devices, imports of medical devices for approval of instructions.
The review of medical device specifications should be reviewed in conjunction with the review of the registration of medical devices, the content of the specifications should be consistent with the relevant content of the registration review.
Article VI of the drug supervision and management department of the medical device specification review is based on product standards, product type test results, clinical trial reports and expert review. Approved medical device instructions and instructions approval shall not be unauthorized changes.
Article VII of the medical device specification should use the State Language and Literature Commission announced the standardization of Chinese characters, can be attached to other languages.
Article VIII of the medical device instructions shall follow the "Industrial Product Instructions - General" national standards, according to the special characteristics of medical devices, should include the following relevant content:
(a) product name, producer's name, address, zip code and contact phone number;
(b) product registration number;
(C) the implementation of product standards;
(D) the product's main structure, performance, specifications; product use, scope of application, contraindications, precautions, warnings and suggestive instructions;
(E) labeling, labeling, graphic symbols, abbreviations and other content of the explanation;
(F) installation and use of the instructions or diagrams;
(VII) product maintenance and Maintenance methods, special storage methods, the use of the period;
(viii) product standards should have other content.
Article IX manufacturers to change the product use, scope of application, contraindications, product standards and change the name of the product, the producer's name, address, should be in accordance with the "Measures for the Administration of Registration of Medical Devices" to fulfill the procedures for changing the relevant contents of the instructions for the change of medical devices.
Article X of the medical device specification shall not contain the following content:
(a) the efficacy of assertions or guarantees: such as "the best efficacy", "guarantee a cure", "cure ", "cure", "instant effect", "completely free of toxic side effects", etc.;
(ii) "the highest technology", "the most scientific", "the most advanced" and other similar absolute language and expression;
(c) stating that the "cure rate ", "effective rate" and comparison with other products and absolute terms;
(d) "insurance company", "invalid refund" and other promising language;
(e) "the most scientific", "the most advanced", "the most advanced", etc.;
(f) "the most advanced", "the most scientific", "the most advanced", etc. "and other promissory language;
(v) the use of any unit, third-party organizations or individuals in the name of the recommendation;
(vi) make people feel that they have suffered from a certain disease, so that people misunderstand that they will not use the medical device will suffer from a certain disease or aggravate the condition of the expression;
(vii) obscenity, superstition, absurdity, and horror of the text;
(viii) other content prohibited by laws and regulations.
Article XI of the medical device product name should be consistent with the State Drug Administration of medical device naming rules.
Article XII of the general name of medical devices should be marked in the product specification, there are trade names, should be marked at the same time the trade name.
Article XIII of the medical device instructions on precautions, warnings and reminders mainly include:
(a) the intended function of the product and the possible side effects;
(b) the product in the process of use of the accident, the operator and the user's protective measures and emergency and corrective measures should be taken;
(c) single-use products should indicate "single-use". Products should indicate "single-use";
(d) sterilized products should indicate "sterilized", sterilized products, should indicate the sterilization package damage to the treatment method. Need to be sterilized before use should indicate the sterilization method.
(e) the product must be installed with other products or co-operation, must indicate the characteristics of the products used in conjunction;
(f) in the process of using other products and other products interfere with each other and the possible dangers;
(g) according to the characteristics of the product, should be prompted by the user, the operator should pay attention to other matters.
Article 14 The content of the instructional documents for installation shall be able to ensure that the user is correctly installed and used. Should include:
(a) product installation instructions and technical drawings, wiring diagrams;
(b) the environmental conditions necessary for the correct installation of the product and identify whether the correct installation of technical information;
(c) other special installation requirements.
Article XV of the medical device labeling and packaging marking should be consistent with the relevant national standards or regulations and the relevant content of these provisions.
Article XVI of these provisions by the State Drug Administration is responsible for the interpretation.
Article XVII of these provisions since May 1, 2002 shall come into force.
Attachment: medical device specification approvals (a)