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Medical Devices
Provisions for Instruction Manuals, Labels and Packaging Marks of Medical Devices
    Pubtime: 2012-03-20

Article 1 The Provisions are formulated with the view to standardizing the instruction manuals, labels and packaging marks of medical devices and ensuring the safe use of medical devices in accordance with the Regulations for the Supervision and Administration of Medical Devices.

Article 2 All the medical devices for sale and use within the territory of the People’s Republic of China shall be attached with instruction manuals, labels and packaging marks in accordance with the Provisions. For simple and easy-to-use products, where among the instruction manuals, labels and packaging marks, either one or two of them can be omitted in accordance with the provisions of the State Food and Drug Administration, the provisions shall be applied.

Article 3 Users shall follow instruction manuals in their use of medical devices.

Article 4 Instruction manual of medical device refers to the technical document developed by the manufacturer of a device and provided to users along with the medical device, which covers the basic information about the safety and effectiveness of the product and can be used to guide proper installation, adjustment, operation, use, and maintenance of the product.

Label of medical device refers to the word explanations, figures or symbols on a medical device or its packages, which are used to identify the features of the product.

Packaging mark of medical device refers to the word explanation, figure or symbol on packages of a medical device, which reflect its major technical features.

Article 5 The information in the instruction manual, label and packaging mark of a medical device shall be authentic, complete, accurate and scientific and shall conform to the features of the product.

The information in the label and packaging mark of a medical device shall be consistent with relevant information in the instruction manual.

Article 6 Words in the instruction manual, label and packaging mark of a medical device shall be in Chinese and their translations into other languages can be supplemented. The use of Chinese shall conform to the language norms commonly practiced in China.

Words, symbols, figures, tables, numbers, photos and pictures in the instruction manual, label and packaging mark shall be accurate, clear and standard.

Article 7 The instruction manual of a medical device shall comply with relevant requirements of the national or industry standards and shall include the following:

1. product name, model and specification;

2. manufacturer name, registered address, manufacture address, contact and after-sales service office;

3. the serial number of the Medical Device Manufacturing Enterprise License (Class I medical device excluded), the serial number of the Medical Device Registration Certificate;

4. the serial number of the product standard;

5. performance, main structure and indications of the product;

6. contraindications, precautions and matters which need to be informed, warned or reminded of;

7. explanation of figures, symbols and abbreviations used in the label of medical device;

8. installation and operation instructions or diagrams ;

9. maintenance methods, including the special storage conditions and methods;

10. term of validity, if the product could only be used within a time limit ;

11. other information that shall be included in the instruction manuals as stipulated in the product standard.

Article 8 The label and packaging mark of a medical device shall include the following information:

1. product name, model and specification;

2. manufacturer name, registered address, manufacture address and contact;

3. Medical Device Registration Certificate number;

4. serial number of the product standard;

5. production date or batch number (manufacturing code) ;

6. conditions for power connection and input power;

7. term of validity, if the product could only be used within a time limit;

8. figures, symbols and other relevant information as required by the product features.

Article 9 The following contents shall not be included in the instruction manual, label and packaging mark of a medical device:

1. phrases which make assertions or guarantees about the effectiveness of the medical device, such as “most effective”, “cure guaranteed”, “cure-all”,“permanent cure”, “instant effect”, “free from any toxic or other side effects”, etc.

2. language expressions of absoluteness, such as “state-of-the-art technology”,“most scientific”, “most advanced”, “the best”, etc.

3. the cure rate or the rate of effectiveness;

4. comparison with the products made by other manufacturers in effectiveness and safety;

5. words of commitment, such as “insured”, “refund if ineffective”, etc.

6. testimony or recommendation given in the name or image of any entity or individual;

7. expressions which can lead to the feeling that one has suffered from certain disease, or the misunderstanding that if one does not use the medical device, a certain disease will occur or become worse;

8. other information which is prohibited by laws and regulations.

Article 10 The product name of a medical device shall conform to the related standards and provisions of the State.

Article 11 The product name shall appear clearly in the prominent position of the instruction manual, label and packaging mark and shall be consistent with the product name in the Medical Device Registration Certificate.

Article 12 Where the medical device has a trade name, the trade name can also appear in the instruction manual, label and packaging mark and shall be consistent with the trade name in the Medical Device Registration Certificate. Where both product name and trade name are marked, they shall be in separate lines, (instead of being in a row,) and the words of the trade name shall not be more than twice those of the product name in size.

The trade name of a medical device shall not contain absolute expressions, which exaggerate or assert the effectiveness of the product, and it shall not violate the provisions in other laws and regulations.

Article 13 The instruction manual of a medical device shall give precautions, warnings and suggestions in the following major aspects:

1. side effects which may result from the use of the product;

2. protective, emergency and corrective measures to be taken for the benefit of operators and users where accidents occur in the proper use of the product,;

3. a disposable product should be marked with words or signs indicating “for single use”;

4. a sterilized product shall be marked as “sterilized”in words or signs with the sterilization procedure specified, and the way of handling in case of package damage shall also be specified ;

5. where the product needs to be disinfected or sterilized before use, the procedure shall be specified;

6. where the product needs to be installed or operated in conjunction with other products, the requirements for the combined use/co-operating shall be specified;

7. interference with other products that may occur in use and its possible dangers;

8. where the product needs to be disposed of after use, the disposal procedure shall be specified;

9. other warnings for operators and users, in accordance with the product features.

Article 14 The instruction manual shall include the following information about installation to ensure proper installation and use on the part of operators and users;

1. illustrations of installation, technical and circuit diagrams;

2. environmental conditions for installation and technical information identifying whether the installation is proper;

3. other special requirements for installation.

Article 15 When applying for medical device registration, manufacturers shall submit the instruction manual to the (food and) drug regulatory departments in accordance with the Provisions for Medical Device Registration and the contents in the submitted instruction manual shall be consistent with those in other materials used for registration application.

Article 16 Manufacturers shall be responsible for the authenticity and integrity of the contents in their medical device instruction manuals.

Article 17 Without authorization, no alternations shall be made to the contents of the medical device instruction manuals which have passed the examination for product registration by the (food and) drug regulatory departments.

Article 18 Where the change of the instruction manual is subject to the situation for medical device re-registration specified by the Provisions for Medical Device Registration, it shall not be dealt with as an instruction manual change.

Article 19 Where the change to the content of the instruction manual that has passed the examination for product registration is irrelevant to technical aspects of the product, a manufacturer shall submit relevant documents and notify the original approval authority of medical device registration in written form. The following information is essential in the relevant documents:

1. a copy of the instruction manual which has been examined for registration and filed;

2. the changed instruction manual to be filed;

3. explanations about the changes in the instruction manual (including a comparison table on changes);

4. documents of the changed standards of the registered product (restricted only to the case where the changes of the instruction manual result in changes of word expressions concerning the product standards);

5. statement on the authenticity of the submitted materials.

Within 20 working days from the date the written document about the instruction manual change is submitted to the original examination and approval authority of registration, where no written notice is issued stating different opinions, the changed instruction manual becomes valid and shall be filed with the original examination and approval authority of registration. Where a written notice is issued within 20 days, the manufacturer shall act in accordance with the notice.

Article 20 Violation of the Provisions by committing any of the following acts shall be warned, ordered for correction within a time limit and be put into the supervision files of manufacturers by the drug regulatory departments at or above the county level:

1. to make unauthorized changes to the instruction manuals which have been examined for registration and filed;

2. the labels and packaging marks of the marketed products do not conform to the contents in the instruction manuals which have been examined for registration and filed, or violate other requirements in the Provisions;

3. the product names or trade names of medical devices are incompliance with the Provisions;

4. the marketed products are not attached with instruction manuals, labels and packaging marks as required, with the exception of simple and easy-to-use products, for which the State Food and Drug Administration has stipulated other provisions.

Article 21 Where application scope or indications of a medical device in the instruction manual is added without authorization, the manufacturer concerned shall be punished by the (food and) drug regulatory departments at or above the county level, in accordance with provisions regarding production without registration certificates in Article 35 of the Regulations for Supervision and Administration of Medical Devices.

Article 22 The Provisions shall be interpreted by the State Food and Drug Administration of the People’s Republic of China.

Article 23 The Provisions shall come into force as of the date of promulgation. The Provisions for the Instruction Manuals of Medical Devices, issued on January 4th, 2002, shall be annulled there from.
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