Order of the National Medical Products Administration

No. 6

　　The “Regulations on the Management of Instructions and Labels for Medical Devices” were reviewed and approved at the Bureau Meeting of the State Administration for Food and Drug Administration on June 27, 2014. They are hereby promulgated and shall take effect as of October 1, 2014.

　　Director 　Zhang Yong

　　July 30, 2014

　　Regulations on the Management of Medical Device Instructions and Labels

　　 Article 1 　To standardize the instructions and labels for medical devices and ensure the safe use of medical devices, these Regulations are formulated in accordance with the "Regulations on the Supervision and Administration of Medical Devices."

　　 Article 2 All medical devices sold and used within the territory of the People's Republic of China shall be accompanied by instructions and labels in accordance with the requirements of these regulations.

　　 Article 3 A medical device instruction manual is a technical document prepared by the registrant or filer of the medical device and provided to users along with the product. It contains essential information about the safety and effectiveness of the product and serves as a guide for its proper installation, commissioning, operation, use, maintenance, and care.

　　Medical device labels refer to the textual descriptions, graphics, and symbols affixed to medical devices or their packaging, used to identify product characteristics and indicate safety warnings and other relevant information.

　　 Article 4 　The content of medical device instructions and labels shall be scientific, truthful, complete, and accurate, and consistent with the product’s characteristics.

　　The content of medical device instructions and labels shall be consistent with the relevant information that has been registered or filed.

　　The content on medical device labels shall be consistent with the relevant information in the instructions.

　 　Article 5 　The descriptions of disease names, specialized terms, diagnostic and therapeutic procedures, and outcomes on medical device instructions and labels shall use nationally standardized or officially approved specialized terminology. Units of measurement and weights shall comply with the relevant national standards.

　　 Article 6 　The symbols or identification colors used in medical device instructions and labels shall comply with the relevant national standards. If there are no applicable national standards, such symbols and identification colors shall be described in the instructions.

　　 Article 7 　The smallest sales unit of a medical device shall be accompanied by an instruction manual.

　　Users of medical devices shall use them in accordance with the instructions.

　　 Article 8 　The product name of a medical device shall use a generic name that complies with the medical device naming rules established by the National Medical Products Administration. The product names of Class II and Class III medical devices shall be consistent with the product names specified in the medical device registration certificate.

　　The product name should be clearly indicated in a prominent position on both the instruction manual and the label.

　　 Article 9 　The text content of medical device instructions and labels shall be in Chinese, and the use of Chinese shall comply with the national standard norms for language and characters. Medical device instructions and labels may include additional languages, but the Chinese version shall prevail.

　　The text, symbols, tables, numbers, graphics, and other elements on medical device instructions and labels shall be accurate, clear, and standardized.

　 　Article 10 　Medical device instructions for use generally should include the following contents:

　　(1) Product name, model, and specifications;

　　(2) The name, address, contact information, and after-sales service provider of the registrant or filer; for imported medical devices, the name, address, and contact information of the agent shall also be indicated.

　　(3) The name, address, production site, contact information, and production license number or production filing certificate number of the manufacturing enterprise; in cases of commissioned production, the name, address, production site, production license number, or production filing certificate number of the contracted manufacturer shall also be indicated.

　　(4) The registration certificate number or filing voucher number for the medical device;

　　(5) The identification number of the product’s technical requirements;

　　(6) Product performance, main structural components or ingredients, and intended use;

　　(7) Content regarding contraindications, precautions, warnings, and reminders;

　　(8) Instructions for installation and use, or diagrams, shall also include special instructions for safe use when the medical device is intended for individual consumer use.

　　(9) Methods for product maintenance and care, as well as special storage and transportation conditions and methods;

　　(10) Date of manufacture, shelf life, or expiration date;

　　(11) Parts list, including details on parts, accessories, replacement cycles for consumables, and instructions on how to replace them;

　　(12) Explanation of the graphics, symbols, abbreviations, and other content used on medical device labels;

　　(13) The date of preparation or revision of the instruction manual;

　　(14) Other content that should be indicated.

　　Article 11 　The precautions, warnings, and advisory information included in medical device instructions mainly comprise:

　　(1) The intended users of the product;

　　(2) Potential safety hazards and usage restrictions;

　　(3) Protective measures for operators and users in the event of accidents occurring during proper use of the product, as well as the emergency and corrective measures that should be taken;

　　(4) Necessary monitoring, evaluation, and control measures;

　　(5) Single-use products shall be marked with the words or symbols “Single-use.” Sterilized products shall indicate the sterilization method as well as the handling procedures to be followed if the sterile packaging is damaged. Products requiring disinfection or sterilization before use shall specify the methods for such disinfection or sterilization.

　　(6) When a product needs to be installed or used in conjunction with other medical devices, the requirements for the combined use of devices, the methods of use, and precautions shall be specified.

　　(7) Potential mutual interference with other products during use and any associated hazards that may arise;

　　(8) Adverse events that may occur during product use, or ingredients or excipients contained in the product that may cause side effects;

　　(9) When disposing of medical devices, attention should be paid to the following: If a product requires disposal after use, the corresponding disposal method must be indicated.

　　(10) Other matters that operators and users should pay attention to, based on the product characteristics.

　　Article 12 　Reusable medical devices shall clearly specify in the instructions the procedures for their repeated use, including the methods for cleaning, disinfection, packaging, and sterilization, as well as the number of times they can be reused or other applicable limitations.

　　Article 13 　Medical device labels generally should include the following information:

　　(1) Product name, model, and specifications;

　　(2) The name, address, and contact information of the registrant or filer; for imported medical devices, the name, address, and contact information of the agent shall also be indicated.

　　(3) The registration certificate number or filing voucher number for the medical device;

　　(4) The name, address, production site, contact information, and production license number or production filing certificate number of the manufacturing enterprise; in cases of commissioned production, the name, address, production site, production license number, or production filing certificate number of the contracted manufacturer shall also be indicated.

　　(5) Date of manufacture, shelf life, or expiration date;

　　(6) Power connection requirements and input power;

　　(7) Graphical symbols, markings, and other relevant information that should be indicated according to the product characteristics;

　　(8) Necessary warnings and precautions;

　　(9) Special storage, handling conditions, or instructions;

　　(10) Medical devices that, during use, cause environmental damage or have negative impacts on the environment shall have warning signs or Chinese-language warning instructions on their labels.

　　(11) Medical devices containing radioactive or radiation-emitting materials shall have warning signs or Chinese-language warning instructions on their labels.

　　If the medical device label is limited in terms of location or size and cannot fully display all of the above-mentioned information, it shall at least indicate the product name, model number, specifications, date of manufacture, and expiration date or use-by date. Additionally, the label must clearly state: “For other details, refer to the instruction manual.”

　　Article 14 　Medical device instructions and labels shall not contain the following:

　　(1) Claims or guarantees that contain assertions of efficacy such as “best therapeutic effect,” “guaranteed cure,” “certain cure,” “radical cure,” “immediate effectiveness,” or “completely free of toxic side effects”;

　　(2) Containing absolute terms and expressions such as “highest technology,” “most scientific,” “most advanced,” and “best”;

　　(3) Those indicating the cure rate or efficacy rate;

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

　　(5) Containing promise-based language such as “insurance provided by the insurance company” or “non-refundable if invalid”;

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

　　(7) Statements containing misleading information that give the impression that a person already has a certain disease, or that mislead people into believing that failure to use the medical device will result in contracting a certain disease or worsening an existing condition, as well as other false, exaggerated, or misleading content;

　　(8) Other content prohibited by laws and regulations.

　　Article 15 　The instructions for medical devices shall be submitted to the food and drug administration for review or filing by the applicant for registration or the registrant at the time of medical device registration or filing. The content of the submitted instructions must be consistent with other registration or filing materials.

　 　Article 16 　The content of medical device instructions that have been registered and reviewed by the food and drug administration shall not be altered without authorization.

　　If a registered medical device undergoes a registration change, the applicant shall, upon obtaining the change document, independently revise the instructions and labels in accordance with the change document.

　　If any other contents of the instruction manual are changed, the manufacturer shall notify the approval authority responsible for medical device registration in writing and submit relevant documents, such as a comparison document detailing the changes made to the instruction manual. If, within 20 working days from the date of receipt of the written notification, the approval authority fails to issue a notice of disapproval, the revised instruction manual shall take effect.

　 　Article 17 If any changes occur to the information listed in the registration form, the technical requirements for the registered medical device, or other contents of the instructions for use, the registrant shall independently update the relevant content in the instructions and labels.

　　Article 18 　If the instructions and labels do not comply with the requirements of these regulations, the food and drug administration departments at or above the county level shall impose penalties in accordance with Article 67 of the "Regulations on the Supervision and Administration of Medical Devices."

　　Article 19 These Regulations shall take effect as of October 1, 2014. The “Regulations on the Management of Instructions for Medical Devices, Labels, and Package Markings,” promulgated on July 8, 2004 (formerly Order No. 10 of the former State Food and Drug Administration), shall be repealed concurrently.