Provisions for Instructions and Labels of Medical Devices (Decree No.6 of China Food and Drug Administration)
Issued on July 30, 2014
Decree No.6 of China Food and Drug Administration
The Provisions for Instructions and Labels of Medical Devices, adopted at the executive meeting of China Food and Drug Administration on June 27, 2014, is hereby promulgated and shall be effective as of October 1, 2014.
Minister: Zhang Yong
July 30, 2014
Provisions for Instructions and Labels of Medical Devices
Article 1 The Provisions is formulated according to the Regulations on Supervision and Administration of Medical Devices for the purpose of regulating instructions and labels of medical devices and ensuring safe use of medical devices.
Article 2 All medical devices sold or used within the territory of the People's Republic of China shall be accompanied by the instructions and labels in accordance with the requirements of the Provisions.
Article 3 Medical device instructions refer to those technical documents that are formulated by registrants or filing entities of medical devices, provided to users together with the products, covering their basic safety and effectiveness information, to guide the correct installation, testing, operation, use, repair and maintenance of products.
Medical device labels refer to the information in the forms of text, graphics and symbols that are printed or attached on medical devices or their packages, and are used for identifying product features and indicating safety warnings, etc..
Article 4 Contents in the instructions and labels of medical devices shall be scientific, authentic, complete, accurate, and shall be consistent with product characteristics.
Contents in the instructions and labels of medical devices shall be consistent with the relevant information in their registration or filing.
Contents in medical device labels shall be consistent with those in medical device instructions.
Article 5 Descriptions of disease names, professional terms, processes and results of diagnosis and therapies in the instructions and labels of medical devices shall adopt nationally publicized or authorized terminology. Metrological units shall meet the requirements in corresponding national standards.
Article 6 Symbols or identification colors used in the instructions and labels of medical devices shall meet corresponding national standards. Where no such standards exist, the symbols and identification colors shall be described in the instructions.
Article 7 Instructions shall be attached to the minimal sale unit of medical devices.
Users of medical devices shall use medical devices following the instructions.
Article 8 Product names of medical devices shall adopt general names, which shall meet the rules of nomenclature of medical devices formulated by China Food and Drug Administration. Product names of class II and class III medical devices shall be consistent with the product names in the corresponding medical device registration certificates.
Product names of medical devices shall be clearly placed on prominent position of the instructions and labels.
Article 9 Text in the instructions and labels of medical devices shall be in Chinese, and the use of Chinese shall meet the national general rules for language and words. Other languages are optional in the instructions and labels of medical devices, but the Chinese version shall prevail.
Words, symbols, tables, figures and graphics in the instructions and labels of medical devices shall be accurate, clear and standardized.
Article 10 In general, the following content shall be included in medical device instructions:
(1) Name, model and specification of the product;
(2) Name, residence, contacts of registrant or filing entity and after-sales service agency. For import medical devices, name, address and contacts of the agent shall be also specified.
(3) Name, residence, manufacturing address, contacts and production license number or filing number of medical device manufacturer. For contract manufacturing, name, address, manufacturing address, production license number or filing number of contracted manufacturer shall be also specified.
(4) Registration certificate number or filing number of the medical device.
(5) Number of product technical requirements.
(6) Performance, main structure, composition or ingredients and scope of application of the product.
(7) Contraindications, precautions, warnings and suggestive descriptions.
(8) Installation and use instructions or illustrations; medical devices intended for personal use shall also be attached with special instructions for safe use.
(9) Product repair and maintenance methods, special conditions and methods for storage and transportation.
(10) Manufacturing date, service life or expiration date.
(11) Accessories list, including accessories, appendants, and instructions for replacement interval and replacement methods of consumables.
(12) Description for graphics, symbols and abbreviations used in medical device labels.
(13) Compilation or revision date of the instructions.
(14) Other information which should be indicted.
Article 11 Precautions, warnings and suggestive descriptions in medical device instructions mainly include:
(1) User of the product.
(2) Potential safety hazards and use restriction.
(3) Protective measures for operators and users, and emergent and corrective measures that shall be taken, when accidents occur in proper use of the product.
(4) Necessary monitoring, evaluation, and control methods.
(5) The word “Single-use” or a symbol shall be marked for disposable products. For sterilized products, sterilization methods and handling methods for the occasion when sterile package is broken shall be indicated. For product needs to be disinfected or sterilized before use, methods of disinfection or sterilization shall be specified.
(6) For a product needs to be installed or used in combination with other medical devices, requirements, use methods and precautions of the combining medical devices shall be provided.
(7) Interferences with other products and possible harm that may occur during the use of the products.
(8) Potential adverse events in the use of product, or ingredients or excipients in product composition that may introduce side effects.
(9) Precautions for medical device discarding or disposal. For products that need to be disposed after use, disposal methods shall be provided.
(10) Other issues, according to product features, that the operators or users shall be alerted of.
Article 12 For reusable medical devices, treatment processes, including methods of cleaning, disinfection, packaging and sterilization, as well as times of reuse and other restrictions, shall be provided in instructions.
Article 13 Generally, the following content shall be included in medical device labels:
(1) Name, model and specification of product.
(2) Name, address, contacts of registrant or filing entity; for import medical devices, name, address and contacts of the agent shall be also specified.
(3) Registration certificate number or filing number of the medical device.
(4) Name, residence, manufacturing address, contacts and production license number or filing number of medical device manufacturer. For contract manufacturing, name, address, manufacturing address, production license number or filing number of contracted manufacturer shall be also specified.
(5) Manufacturing date, service life or expiration date.
(6) Conditions for power connection and input power.
(7) Graphics, symbols and other relevant information, according to product features, that shall be marked.
(8) Necessary warnings and precautions.
(9) Conditions or explanations for special storage and operation.
(10) For a medical device causing hazard to or having negative effects on the environment, a warning symbol or a warning description in Chinese shall be included in the label.
(11) For medical devices that are radioactive or with radiation, a warning symbol or a warning description in Chinese shall be included in the label.
Where all the above-mentioned information may not be covered completely in the label due to the limits of its position or size, the label shall at least contain name, model, specifications, manufacturing date, service life or expiration date of the product, and a sentence of "Refer to instructions for other details" shall be clearly indicated in the label.
Article 14 Medical device instructions and labels shall not contain the following contents:
(1) Asserts or assurances indicating functions or effects, such as "best therapeutic effect", "guaranteed cure", "cure all", "complete cure", "immediate effect" and "completely free from toxicity or side-effect", etc..
(2) Absolute expression or words, such as "the highest technology", "the most scientific", "the most advanced", "the best", etc..
(3) Claim of cure rate or effective rate.
(4) Comparisons of effectiveness and safety with products of other manufacturers.
(5) Promissory descriptions like "secured by insurance company" or "refund for no effect".
(6) Using name or image of any entity or person for proof or recommendation.
(7) Misleading descriptions that make people feel they might have some diseases or misunderstand or they might get certain diseases or the diseases would be aggravated without using the medical devices, and other false, exaggerated and misleading information.
(8) Other contents forbidden by laws or regulations.
Article 15 Medical device instructions shall be submitted by registration applicant or filing entity to food and drug regulatory authorities for review or filing in application for medical device registration or filing. The submitted instructions shall be consistent with registration or filing documents.
Article 16 The instructions approved by food and drug regulatory authorities shall not be changed without authorization.
For registration changes to the registered medical device, registration applicants shall modify the contents of the instructions and labels by themselves according to the change certificate obtained.
For changes of other contents of the instructions, registration applicant shall inform the regulatory authorities responsible for registration approval in writing, and submit comparison descriptions and relevant documents of changes. Instructions change takes effects, if the regulatory authorities responsible for registration approval do not send a formal notice of rejection within 20 working days from the date they are informed in writing by the registration applicant.
Article 17 Where changes occur to contents included in the filing information form, the technical requirements of filed medical device, and other contents in the instructions, the filing entities shall modify the relevant contents of the instructions and labels by themselves.
Article 18 Where the instructions and labels fail to comply with the Provisions, punishment shall be imposed by the food and drug regulatory departments at or above the county level according to stipulations of Article 67 of Regulations on Supervision and Administration of Medical Devices.
Article 19 The Provisions shall be effective as of October 1, 2014. The Provisions on the Administration of Instructions, Labels and Package Marks of Medical Devices promulgated on July 8, 2004 (Decree No.10 of the former Sate Food and Drug Administration) is annulled simultaneously.
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