Regulations on the management of instructions, labels and packaging marks of medical devices

Article 1 These Provisions are formulated in accordance with the regulations on the supervision and administration of medical devices in order to standardize the instructions, labels and packaging marks of medical devices and ensure the safety of medical devices.

Article 2 all medical devices sold and used within the territory of the people's Republic of China shall be attached with instructions, labels and packaging marks in accordance with the requirements of these provisions. For simple and easy-to-use products, according to the provisions of the State Food and drug administration, one or both of the three items of instruction, label and package identification can be omitted, and the provisions shall prevail.

Article 3 users of medical devices shall use medical devices in accordance with the instructions for medical devices.

Article 4 the medical device instruction refers to the technical document produced by the manufacturer and provided to the user along with the product, which can cover the basic information of the safety and effectiveness of the product and guide the correct installation, commissioning, operation, use, maintenance and service.

Medical device label refers to the written description, graphics and symbols attached to medical devices or packages to identify product characteristics.

Medical device package identification refers to the written description, graphics and symbols that reflect the main technical characteristics of medical devices marked on the package.

Article 5 the contents of the instructions, labels and package marks of medical devices shall be true, complete, accurate, scientific and consistent with the product characteristics.

The contents of labels and package marks of medical devices shall be consistent with the relevant contents of the instructions.

Article 6 the contents of the instructions, labels and package labels of medical devices must be in Chinese, and other languages may be added. The use of Chinese shall conform to the norms of the language commonly used by the state.

The words, symbols, figures, tables, figures, photos and pictures of the instructions, labels and package marks of medical devices shall be accurate, clear and standardized.

Article 7 the 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;

（2） Name, registered address, production address, contact information and after-sales service unit of the manufacturer;

（3） The number of medical device manufacturer's license (except for class I medical devices) and the number of medical device registration certificate;

（4） Product standard number;

（5） Product performance, main structure and scope of application;

（6） Contraindications, precautions and other contents requiring warning or prompt;

（7） Explanation of graphics, symbols, abbreviations and other contents used in medical device labels;

（8） Installation and use instructions or diagrams;

（9） Product maintenance and service methods, special storage conditions and methods;

（10） For products to be used within a time limit, the expiry date shall be indicated;

（11） Other contents specified in the product standards that should be indicated in the instructions.

Article 8 the label and package identification of medical devices shall generally include the following contents:

（1） Product name, model and specification;

（2） Name, registered address, production address and contact information of the manufacturer;

（3） Medical device registration certificate number;

（4） Product standard number;

（5） Production date or batch (serial) number of the product;

（6） Power connection conditions and input power;

（7） For products to be used within a time limit, the expiry date shall be indicated;

（8） Graphics, symbols and other relevant contents that should be marked according to product characteristics.

Article 9 the instructions, labels and package marks of medical devices shall not contain the following contents:

（1） Assertions or guarantees indicating efficacy such as "best curative effect", "guaranteed cure", "guaranteed cure", "radical cure", "immediate effect" and "completely non-toxic side effects";

（2） Containing absolute language and expression such as "the highest technology", "the most scientific", "the most advanced", "the best";

（3） Indicating the cure rate or effective rate;

（4） Compared with the efficacy and safety of products of other enterprises;

（5） Containing commitment language such as "insurance company insurance" and "invalid refund";

（6） Using the name or image of any unit or individual as proof or recommendation;

（7） Contains statements that make people feel that they have suffered from a certain disease, or misunderstand that they will suffer from a certain disease or aggravate the disease if they do not use the medical device;

（8） Other contents prohibited by laws and regulations.

Article 10 the product name of medical devices shall conform to the corresponding national standards and regulations.

Article 11 the product name of the medical device shall be clearly marked on the prominent position of the instruction, label and package identification, and shall be consistent with the product name in the medical device registration certificate.

Article 12 If a medical device has a commodity name, the commodity name may be marked in the instruction, label and package identification at the same time, but it shall be consistent with the commodity name marked in the medical device registration certificate. When marking the product name and the commodity name at the same time, they shall be in separate lines and shall not be written together. The text of the commodity name of the medical device shall not be more than twice the text of the product name.

Absolute terms that exaggerate or assert the efficacy of the product shall not be used in the product name of medical devices, and shall not violate the provisions of other laws and regulations.

Article 13 relevant precautions, warnings and tips in the instructions of medical devices mainly include:

（1） Possible side effects of product use;

（2） Protective measures for operators and users and emergency and corrective measures to be taken in case of accidents during the correct use of the product;

（3） Disposable products shall be marked with the words "disposable" or symbols;

（4） Sterilized products shall be marked with the sterilization method, the words "sterilized" or marks, and the treatment method after the sterilization package is damaged;

（5） If disinfection or sterilization is required before use, the method of disinfection or sterilization shall be explained;

（6） When a product needs to be installed or operated together with other products, the requirements for cooperation shall be indicated;

（7） Possible mutual interference with other products and possible dangers during use;

（8） If the product needs to be treated after use, the corresponding treatment method shall be indicated;

（9） Other matters that should be noticed by operators and users according to product characteristics.

Article 14 the contents related to installation in the instructions of medical devices shall be able to ensure the correct installation and use of operators and users, and shall include:

（1） Product installation instructions, technical drawings and circuit diagrams;

（2） The environmental conditions necessary for the correct installation of the product and the technical information to identify whether the product is correctly installed;

（3） Other special installation requirements.

Article 15 when applying for registration of medical devices, the manufacturer shall submit the instructions of medical devices to the (food) drug regulatory department for examination in accordance with the provisions of the measures for the administration of registration of medical devices. The contents of the instructions of medical devices submitted shall be consistent with other registration application materials.

Article 16 the manufacturer shall be responsible for the authenticity and completeness of the contents of the instructions for medical devices.

Article 17 the contents of the instructions for medical devices registered and examined by the (food) drug regulatory department shall not be changed without authorization.

Article 18 If the contents of the change of the instruction involve the circumstances that medical devices should be re registered as stipulated in the measures for the administration of medical device registration, it shall not be treated as the change of the instruction.

Article 19 If the manufacturer changes the contents of the instruction manual of the medical device that has been registered and examined and does not involve the technical changes of the product, the manufacturer shall submit relevant documents and notify the original approval department of the medical device registration in writing. Relevant documents shall at least include:

（1） The duplicate of the instruction that has been registered, reviewed and filed;

（2） Change the filed instruction;

（3） Description of changes in the instruction (including comparison table of changes);

（4） Registered product standard modification documents (only when the modification of the instruction involves the textual modification of the standard);

（5） Statement of the authenticity of the submitted materials.

If the original registration and approval department fails to issue a written notice with different opinions within 20 working days from the date of receiving the written notice of the manufacturer to change the specification of the medical device, the modification of the specification will take effect and be filed by the original registration and approval department; If the original registration examination and approval department issues a written notice within 20 working days, the manufacturing enterprise shall handle it in accordance with the requirements of the notice.

Article 20 in case of any of the following acts in violation of these Provisions, the (food) drug regulatory department at or above the county level shall give a warning, order it to make corrections within a time limit, and record it in the regulatory archives of the manufacturer:

（1） Altering the contents of the registered and filed instruction without authorization;

（2） The labels and package marks of the listed products are in violation of the contents of the registered, examined and filed instructions, or other requirements of these provisions;

（3） The product name or commodity name of the medical device violates these provisions;

（4） The listed products are not attached with instructions, labels and packaging marks as required; Simple and easy-to-use products, unless otherwise specified by the State Food and drug administration.

Article 21 If a medical device manufacturer increases the product application scope or indications in the medical device specification without authorization, the (food) drug supervision and administration department at or above the county level shall punish it according to Article 35 of the regulations on the supervision and administration of medical devices without obtaining the registration certificate of medical devices.

Article 22 The State Food and drug administration is 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 administration of medical device instructions issued by the State Drug Administration on January 4, 2002 shall be abolished at the same time.