Description And Labeling Of Medical Devices Regulations

Original Language Title: 医疗器械说明书和标签管理规定

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Description and labeling of medical devices regulations

    (July 30, 2014 the State food and drug administration released 6th come into force October 1, 2014) first to standardize medical device instructions and labels, ensure the safety of medical devices used, under the supervision and administration of medical devices Ordinance, these rules are formulated.

    Article in the People's Republic of China territory sales and use of medical devices, shall be in accordance with the requirements of this provision include directions and labels.

Article medical device specification is defined by register or record people, supplied with the product to the user, cover basic information that the product is safe and effective, for the guidance of correct installation, commissioning, operation, use, maintenance and repair of technical documents.

    Medical device label refers to the medical device attached is used to identify the product or its packaging characteristics and indicate the safety warning information such as text and graphics and symbols.

Article fourth medical equipment specification and labelling ought to be science, true, complete, accurate, and consistent with the product characteristics.

Medical equipment manuals and labels should be consistent with the relevant elements of the registration or filing.

    The labelling of medical devices shall be compatible with the instructions about the content.

    Fifth Disease medical device instructions and labels names, terminology, diagnosis, treatment and outcome statement, shall use national unity publishing or standard terminology, weights and measures units shall comply with the provisions of the relevant national standards.

    Article sixth medical equipment instructions and labels use symbols or colors should be consistent with the provisions of relevant State standards; no relevant standards and regulations, the symbols and colors should be described in the manual.

Seventh smallest sales unit of medical devices shall be accompanied by instructions.

    Users should follow the instructions for medical devices medical devices. Article eighth of medical device product name should use the common name, generic name should be consistent with national food and drug supervision and administration of medical device naming conventions.

Class II and class III medical device product name should be consistent with the product name in the registration certificate of medical devices.

    Product name should be clearly indicated in the instructions and labels prominently. Nineth medical device instructions and labels the text shall be in Chinese, Chinese written language in common use shall conform to the national standard.

Instructions and labels can be attached to other types of medical devices, but it should be subject to the Chinese.

    Medical device description and tags text, symbols, tables, numbers, graphics, and so on should be accurate, clear, standardized.

Article tenth medical instrument specifications should generally include the following:

(A) the product name, model number, specifications;

(B) the register or record people's names, addresses, contact information, and service units, and imported medical devices shall include the agent's name, domicile and contact;

(C) manufacturer's name, residence, address, contact information and license number or registration certificate number, entrusted to him shall also be marked OEM corporate name, residence, address, license number or registration certificate number;

(D) registration number or registration certificate number of medical devices;

(E) the technical requirements of the product number;

(Vi) product performance, main structure or composition, scope of application;

(G) the contraindications, precautions, warnings and tips content;

(H) the installation and use instructions or diagrams, up to the consumer to use the safe use of medical devices should also have special instructions;

(I) the product maintenance and repair methods, special storage and transportation conditions, methods;

(J) the date of manufacture, use term or expiry date;

(11) parts list, including replacement parts, accessories, loss cycle and replace the description of the method;

(12) the labelling of medical devices used in the graphical interpretation, symbols, abbreviations, and so on;

(13) description date of preparation or revision;

    (14) other annotation contents.

11th medical device specifications the note, warning, and informational content includes:

(A) the products use objects;

(B) the potential safety hazard and use restrictions;

(C) when an accident occurs in the correct use of the product, to operators, consumer protection measures, as well as emergency response and corrective action should be taken;

(D) the necessary means of monitoring, evaluation and control;

(E) single-use products should be marked with "single-use" words or symbols, sterilized product shall be indicated sterilization and treatment since the sterile packaging is damaged, need to be disinfected or sterilized before use, shall state the method of sterilization or disinfection;

(F) the product when it is installed or used in combination with other medical devices, you should indicate the requirement of joint use of equipment, methods of use, attention;

(G) in the course of using, and other products may interfere with each other and their harm that may occur;

(H) the product may cause adverse events or product components contain ingredients that may cause side effects or accessories;

(I) the disposal of medical devices should be aware of products after use, need to be addressed, you should indicate the appropriate approach;

    (10) according to the product characteristics, should prompt the operator and the users ' attention to other matters.

    12th reusable medical devices should be made clear in a statement to reuse part of the process, including cleaning, disinfection, packaging and sterilization and reuse a number or other restrictions.

13th the labelling of medical devices should generally include the following:

(A) the product name, model number, specifications;

(B) the registered person or record the person's name, address, contact, import medical devices shall include the agent's name, domicile and contact;

(C) the registration number or registration certificate number of medical devices;

(D) the manufacturer's name, residence, address, contact information and license number or registration certificate number, entrusted to him shall also be marked OEM corporate name, residence, address, license number or registration certificate number;

(E) the date of manufacture, use term or expiry date;

(F) the conditions of power supply, input power;

(G) according to the product characteristics shall label graphics, symbols and other relevant content;

(H) the necessary warning and cautions;

(I) special storage, handling conditions or instructions;

(J) the damage or negative impact on the environment in the use of medical devices, its label should contain the warning marks or warning specifications in Chinese;

(11) medical device with radiation or radiation, its label should contain the warning marks or warning specifications in Chinese.

    Labelling of medical devices because of location or size restriction but not all indicated above, at least marking product name, model number, specifications, production date and shelf life or expiry date, and clearly in the label "other content as described in the manual."

14th medical device instructions and labels may not have the following:

(A) the "best", "guarantee a cure", "cure", "radical", "immediate effect", "totally harmless" and other terms of assertions or assurances;

(B) contain "high technology", "Science" and "the most advanced" and "best" and absolute language;

(C) that the cure rate, or the efficiency of;

(D) the product efficacy and safety compared with other businesses;

(E) "insurance", "invalid refund" commitments such as language;

(Vi) use on behalf of any unit or individual, image or recommendation;

(VII) contains a misleading description, makes people feel already suffer from a disease, or misleading not to use the medical device will suffer from some kind of illness or aggravate the condition, and the other false, exaggerated or misleading content;

    (VIII) other contents prohibited by laws and regulations.

    15th medical equipment manuals should be a registered applicant or record when medical device registration or filing, submitted to the food and drug administration or filing, submitted content should be consistent with the other registration or filing information.

16th registered by the food and drug administration review of the manuals of medical devices must not alter the content.

Registered medical device registration changes, the applicant shall, after having secured changes file, according to the changes file to modify the instructions and labels. Specifications of other content changes shall be made to the medical device registration in informed in writing of the competent departments and submit instructions change the comparative description and other related documents.

    Approval authority within 20 working days of receipt of the written notice does not agree with a notice not one, manual changes to take effect.

    Article 17th record of medical devices, filing information sheet posted content, record technical product requirements and specifications other content changes, record people modify directions and labels of related content.

    18th does not comply with the requirements of the specification and labelling, food and drug supervision and administration departments at or above the county level shall, in accordance with the regulation on supervision and administration of medical devices 67th of the rules will be punished. 19th article of the regulations come into force on October 1, 2014. Released on July 8, 2004, the medical equipment manuals, labeling and packaging regulations (formerly the national food and drug administration, 10th) repealed simultaneously.

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