Article 1 "In order to regulate the instructions and labels of medical devices and ensure the safety 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 The medical device manual refers to the medical device registrant or recorder, which is produced by the medical device registrant or recorder, and provided to the user with the product, covering the basic information about the safety and effectiveness of the product to guide the correct installation, debugging, operation, use, maintenance, and maintenance technology file.
Medical device label refers to the text description, graphics, and symbols attached to the medical device or its packaging to identify product features and indicate safety warnings and other information.
Article 4 The contents of the medical device instructions and labels should be scientific, true, complete, accurate, and consistent with the product characteristics.
The contents of the manual and label of the medical device shall be consistent with the relevant contents registered or filed.
The content of the medical device label should be consistent with the relevant content of the manual.
Article 5 The description of disease names, professional terms, diagnosis and treatment process and results in medical device instructions and labels shall adopt special vocabulary issued or standardized by the state, and the unit of measurement shall comply with the relevant national standards.
Article 6 The symbols or identification colors used in the instructions and labels of medical devices shall comply with the relevant national standards; if there are no relevant standards, the symbols and identification colors shall be described in the instructions.
Article 7 The minimum sales unit of medical devices shall be accompanied by instructions.
Medical device users should use medical devices in accordance with the instructions.
Article 8 The product names of medical devices shall be generic names, and the generic names shall comply with the medical device naming rules formulated by the State Food and Drug Administration. The product names of Class II and Class III medical devices shall be consistent with the product names in the medical device registration certificate.
The product name should be clearly marked in a prominent position in the manual and label.
Article 9 Medical device instructions and label text content should be in Chinese, and the use of Chinese should conform to the national standard of language and writing. Medical device instructions and labels can be attached in other languages, but the Chinese expression shall prevail.
The text, symbols, tables, numbers, graphics, etc. in the instructions and labels of medical devices shall be accurate, clear and standardized.
Article 10 Medical device instructions should generally include the following:
(1) Product name, model, specification;
(2) The name, domicile, contact information and after-sales service unit of the registrant or filing person, and the imported medical device shall also indicate the name, domicile and contact information of the agent;
(3) The name, domicile, production address, contact information, and production license number or production filing certificate number of the production enterprise. If production is entrusted, the name, domicile, production address, production license number or production filing certificate of the entrusted enterprise shall also be marked Numbering;
(4) Medical device registration certificate number or filing certificate number;
(5) The number of product technical requirements;
(6) Product performance, main structural composition or composition, and scope of application;
(7) Contraindications, precautions, warnings and reminders;
(8) Installation and use instructions or pictures, medical devices used by consumers themselves should also have special instructions for safe use;
(9) Product maintenance and maintenance methods, special storage and transportation conditions and methods;
(ten) production date, expiration date or expiration date;
(11) Parts list, including parts, accessories, replacement cycle of worn-out parts and instructions for replacement methods, etc.;
(12) Explanation of graphics, symbols, abbreviations and other content used in medical device labels;
(13) The date of compilation or revision of the manual;
(14) Other content that should be marked.
Article 11 The precautions, warnings and reminders in the medical device manual mainly include:
(1) The object to which the product is used;
(2) Potential safety hazards and usage restrictions;
(3) When an accident occurs during the correct use of the product, the protective measures for the operator and the user, as well as the emergency and corrective measures that should be taken;
(4) Necessary monitoring, evaluation, and control methods;
(5) Disposable products should be marked with the words "one-time use" or symbols, sterilized products should be marked with the sterilization method and the treatment method after the sterilization package is damaged, and disinfection or sterilization should be stated before use. Or the method of sterilization;
(6) When the product needs to be installed or used in conjunction with other medical devices, the requirements, methods of use and precautions for the joint use of devices shall be indicated;
(7) In the course of use, possible mutual interference with other products and possible harm;
(8) Adverse events that may be caused by product use or ingredients or excipients contained in product ingredients that may cause side effects;
(9) Matters that should be paid attention to when disposing of medical devices, if the product needs to be disposed of after use, the corresponding treatment method should be indicated;
(10) According to the characteristics of the product, the operator and user should be reminded of other matters.
Article 12 Reused medical devices shall specify the treatment process of repeated use in the instructions, including the methods of cleaning, disinfection, packaging and sterilization, and the number of repeated use or other restrictions.
Article 13 Medical device labels should generally include the following:
(1) Product name, model, specification;
(2) The name, domicile, and contact information of the registrant or filing person. Imported medical devices should also include the name, domicile and contact information of the agent;
(3) Medical device registration certificate number or filing certificate number;
(4) The name, domicile, production address, contact information, and production license number or production filing certificate number of the production enterprise. If production is entrusted, the name, domicile, production address, production license number or production filing certificate of the entrusted enterprise shall also be indicated Numbering;
(5) Production date, use period or expiration date;
(6) Power connection conditions, input power;
(7) Graphics, symbols and other related content that should be marked according to product characteristics;
(8) Necessary warnings and precautions;
(9) Special storage, operating conditions or instructions;
(10) For medical devices that are harmful to the environment or have a negative impact on the environment in use, their labels should include warning signs or warning instructions in Chinese;
(11) For medical devices that carry radiation or radiation, their labels shall include warning signs or warning instructions in Chinese.
If the medical device label is unable to indicate all the above content due to location or size limitation, at least the product name, model, specification, production date and expiration date should be indicated, and the label should clearly "see the instructions for other contents."
Article 14 Medical device instructions and labels must not contain the following contents:
(1) Containing assertions or guarantees of efficacy such as "best effect", "guaranteed cure", "inclusive cure", "radical cure", "immediate effect", "completely no toxic side effects", etc.;
(2) Absolute language and expressions such as "highest technology", "most scientific", "most advanced" and "best";
(3) State the cure rate or efficiency;
(4) Compared with the efficacy and safety of other companies' products;
(5) Contains promised language such as "insurance company insurance", "invalid refund" and so on;
(6) Using the name or image of any unit or individual as proof or recommendation;
(7) Containing misleading statements that make people feel that they have suffered from a certain disease, or misunderstand that not using the medical device will cause a certain disease or aggravate the disease, and other false, exaggerated, and misleading content;
(8) Other content prohibited by laws and regulations.
Article 15 The medical device instructions shall be submitted to the Food and Drug Administration for review or filing by the registration applicant or recorder when the medical device is registered or filed. The content of the instructions submitted shall be consistent with other registration or filing materials.
Article 16 The contents of the medical device instructions that have been registered and reviewed by the Food and Drug Administration shall not be changed without authorization.
If there is a registration change for a registered medical device, the applicant shall modify the instructions and labels according to the change file after obtaining the change file.
If there are changes in other contents of the manual, it shall be notified in writing to the approval department of the medical device registration, and relevant documents such as a comparative explanation of the changes in the manual shall be submitted. If the examination and approval department fails to issue a notice of disapproval within 20 working days from the date of receipt of the written notification, the modification of the specification shall take effect.
Article 17 For medical devices that have been filed, if the content posted in the filed information sheet, the technical requirements of the filed product, and other contents of the manual change, the filer shall modify the relevant content of the manual and label by himself.
Article 18 If the instructions and labels do not meet the requirements of these regulations, the food and drug administration department at or above the county level shall be punished in accordance with Article 67 of the Regulations on the Supervision and Administration of Medical Devices.
Article 19 These regulations shall come into force on October 1, 2014. The Regulations on the Administration of Medical Device Instructions, Labels and Packaging Marks (formerly Order No. 10 of the State Food and Drug Administration) promulgated on July 8, 2004 shall be repealed simultaneously.
