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Laws & Regulations - Medical Devices - Provisions for Instruction Manuals, Labels and Packaging Marks of Medical Devices
Provisions for Instruction Manuals, Labels and Packaging Marks of Medical Devices
 
2012/3/20 14:45:03¡¡Source: ¡¡Hits:

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 contai

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