Article 3 Users of medical devices shall use medical devices according to the instructions of medical devices.
Article 4 Instructions for medical devices refer to technical documents produced by manufacturing enterprises and provided to users with products, which can cover the basic information of product safety and effectiveness and guide the correct installation, debugging, operation, use, maintenance and maintenance.
Medical device labels refer to text descriptions, figures and symbols affixed to medical devices or packages to identify product features.
Medical device packaging label is a text description, graphics and symbols that reflect the main technical characteristics of medical devices on the packaging.
Article 5 The contents of instructions, labels and packaging marks of medical devices shall be true, complete, accurate and scientific, and consistent with the product characteristics.
The contents of medical device labels and packaging labels should be consistent with the relevant contents of the instructions.
Article 6 The contents of instructions, labels and packaging labels of medical devices must be in Chinese, and other languages may be added. The use of Chinese should conform to the national common language and writing norms.
The words, symbols, graphics, tables, figures, photos and pictures of medical device instructions, labels and packaging labels shall be accurate, clear and standardized. Article 7 Instructions for medical devices shall meet the relevant requirements of national standards or industrial standards, and generally shall include the following contents:
(1) product name, model and specification;
(two) the name, registered address, production address, contact information and after-sales service unit of the production enterprise;
(3) the license number of the medical device manufacturer (except the first type of medical devices) and the registration certificate of the numbered medical devices;
(4) product standard number;
(five) the performance, main structure and scope of application of the product;
(six) contraindications, precautions and other contents that need to be warned or prompted;
(seven) the interpretation of the graphics, symbols, abbreviations and other contents used in the labels of medical devices;
(eight) installation and use instructions or charts;
(nine) product maintenance and maintenance methods, special storage conditions and methods;
(10) For the products to be used within a time limit, the period of validity shall be indicated;
(eleven) other contents stipulated in the product standard that should be indicated in the manual. Article 8 The labels and packaging labels of medical devices shall generally include the following contents:
(1) product name, model and specification;
(2) The name, registered address, production address and contact information of the production enterprise;
(3) Registration number of medical devices;
(4) product standard number;
(five) the date of production or batch number;
(six) power connection conditions, input power;
(seven) the expiration date shall be marked on the products that are used within a time limit;
(eight) graphics, symbols and other related contents that should be marked according to the characteristics of products. Article 9 Instructions, labels and packaging labels of medical devices shall not contain the following contents:
(1) It contains assertions or guarantees indicating efficacy such as "the best curative effect", "guaranteed cure", "guaranteed cure", "radical cure", "quick response" and "no toxic or side effects at all";
(2) It contains such absolute languages and expressions as "the highest technology", "the most scientific", "the most advanced" and "the best";
(3) Indicating the cure rate or effective rate;
(4) Compared with the efficacy and safety of other enterprise products;
(5) It contains promising language such as "underwriting by insurance company" and "invalid refund";
(six) using the name and image of any unit or individual as proof or recommendation;
(7) It contains statements that make people feel that they are suffering from a certain disease, or make people misunderstand that they will suffer from a certain disease or aggravate their condition without using the medical device;
(eight) other contents prohibited by laws and regulations.
Article 10 The product names of medical devices shall conform to the corresponding national standards and regulations.
Article 11 The product name of a medical device shall be clearly indicated in a prominent position in the instructions, labels and packaging marks, and shall be consistent with the product name in the medical device registration certificate.
Article 12 Where a medical device has a commodity name, it may be marked with the commodity name in the instructions, labels and packaging labels at the same time, but it shall be consistent with the commodity name marked in the medical device registration certificate. When the product name and commodity name are marked at the same time, they shall be marked separately, and the number of words of the commodity name of medical devices shall not exceed twice of the product name.
Absolute terms that exaggerate or assert the efficacy of products shall not be used in the names of medical devices, and shall not violate the provisions of other laws and regulations. Article 13 Matters needing attention, warnings and tips in the instructions of medical devices mainly include:
(a) The possible side effects of using the product;
(two) the protection measures for operators and users, and the emergency and corrective measures that should be taken in case of accidents in the correct use of products;
(3) Disposable articles shall be marked with the words "disposable" or symbols;
(4) The sterilized product shall be marked with the sterilization method, the word "sterilized" or logo, and the disposal method after the sterilized package is damaged;
(5) If disinfection or sterilization is required before use, the method of disinfection or sterilization shall be explained;
(six) when the product needs to be installed or operated in cooperation with other products, the requirements for cooperation shall be indicated;
(seven) in the process of use, it may interfere with other products and its possible dangers;
(eight) the product needs to be treated after use, and the corresponding treatment method shall be indicated;
(nine) according to the characteristics of products, other matters that should be reminded to operators and users.
Article 14 The contents related to installation in the instructions of medical devices shall ensure the correct installation and use of operators and users, including:
(a) product installation instructions and technical drawings and circuit diagrams;
(two) the environmental conditions necessary for the correct installation of the product and the technical data to identify whether it is correctly installed;
(3) Other special installation requirements.
Article 15 When applying for medical device registration, a manufacturing enterprise shall submit the medical device instructions to the food and drug supervision and administration department for examination in accordance with the Measures for the Administration of Medical Device Registration, and the contents of the submitted medical device instructions shall be consistent with other registration application materials.
Article 16 A manufacturing enterprise shall be responsible for the authenticity and completeness of the contents of the medical device instructions.
Article 17 The contents of the instructions for medical devices registered and examined by the (food) drug supervision and administration department shall not be changed without authorization.
Article 18 If the contents of the instruction manual change involve the re-registration of medical devices as stipulated in the Measures for the Administration of Medical Device Registration, it shall not be changed according to the instruction manual.
Article 19 If a manufacturing enterprise changes the contents of the medical device manual that has been registered and examined, and it does not involve the technical change of the product, the manufacturing enterprise shall submit relevant documents and notify the original medical device registration and examination and approval department in writing. Relevant documents at least include:
(a) a copy of the instructions that have been registered, reviewed and filed;
(2) An explanation of the change of record;
(3) Description of changes in the manual (including change comparison table);
(four) the revision document of the registered product standard (only when the contents of the manual change involve the revision of the standard text);
(5) A statement of the authenticity of the materials submitted.
If the original registration and examination and approval department fails to issue a written notice of different opinions within 20 working days from the date of receiving the written notice of the manufacturer's change of medical device instructions, the change of instructions will take effect and be filed by the original registration and examination and approval department; If the original registration examination and approval department issues a written notice within 20 working days, the production enterprise shall handle it in accordance with the notification requirements. Twentieth in violation of the provisions, one of the following acts, given a warning by the (food) drug supervision and management departments at or above the county level, ordered to make corrections within a time limit, and recorded in the production enterprise supervision files:
(a) to change the contents of the instructions that have been registered, examined and filed without authorization;
(2) The labels and packaging marks of listed products are contrary to the contents of the instructions that have been registered, reviewed and filed, or violate other requirements of these Provisions;
(3) The product name or commodity name of the medical device violates these Provisions;
(four) the listed products are not accompanied by instructions, labels and packaging marks as required; Simple and easy-to-use products, unless otherwise stipulated by the US Food and Drug Administration.
Article 21 If a medical device manufacturer increases the application scope or indications of the products in the medical device manual without authorization, the (food) drug supervision and administration department at or above the county level shall punish it according to the situation that the medical device registration certificate has not been obtained as stipulated in Article 35 of the Regulations on the Supervision and Administration of Medical Devices.
Article 22 The State Food and Drug Administration shall be responsible for the interpretation of these Provisions. Article 23 These Provisions shall come into force as of the date of promulgation. The Regulations on the Management of Medical Device Instructions issued by the State Medical Device Administration on June 4, 2002 shall be abolished at the same time.