FAQ
Medical Devices

Are there any details about a product’s package insert and label that I need to note?

刊登日期:2019-07-11  |  點閱次數 : 162 次 

(1) Package insert: In general , the term “package insert” refers to the catalog, instruction for use, or operation manual produced by manufacture to clarify details such as the usage, precaution, model, specification, and images of the product, etc.

(2) Product label: The product label should display the product name (the Chinese name should be displayed for a domestic product, whereas the English product name should be displayed for an imported product), manufacturing batch number, name and address of the manufacturer and pharmaceutical firm (a Chinese label containing this information may be provided for imported products). For condoms, sanitary pads, tampons, sterilization products, and implant products, the date of manufacture and expiration or the shelf life shall be clearly noted on the product label. 

(3) Chinese package inserts: For a package insert originally written in a foreign language, a Chinese package insert should be prepared and submitted for official review. The Chinese package insert shall disclose key information about the product and the scope of its application (e.g., product type, the accessories and specification) to enable understanding users and reviewers.

*Note:                                             

A Chinese package insert shall include the Chinese and English name, the Medical device license number, product descriptions, intended use or indications, precautions and warnings, contraindications, side effects, specification, model, how the product is supplied (e.g., sterilized product or pyrogen-free product; if the product must be sterilized before use or can be used repeatedly; suggestions for cleaning, disinfection, and sterilization should also be added), and the name and address of both the manufacturer and the pharmaceutical firm. The Chinese package insert should not serve any advertising or promotional purposes and should not contain any exaggerated or advertising language or tone. For imported medical devices, the content of the Chinese package insert should accurately reflect the content of the original foreign package insert.    

The name, model, and specification printed on the Chinese package insert should be identical to that printed on the manufacture and free sale certificate. Other technical information described in the Chinese package insert should match the technical and inspection information provided by the original manufacturer. Finally, the information displayed on the product label and package insert should match the information provided by the original manufacturer.

(4) Common mistakes:

a. Incorrect country of origin printed on the label (e.g., the label describes that the product was made in the United States, but the manufacturer was not physically in United States).  

b. Inconsistency regarding information (e.g., “sterile”, “pyrogen-free”, and “for single use only”) printed on the product label and the package insert. For example, the label describes that the product is sterile and for single use only while the package insert describes that the product is non-sterile and can be used repeatedly.

c. Incorrect information about the sterilization method on the label (e.g., the label describes that the product was ethylene oxide (EO)-sterilized whereas the technical and sterilization validation information is supportive to a radiation sterilization product). 

d. The product name, model and specification printed on the label and package insert are incorrect or do not match the information on the manufacture and free sale certificate.

The information describe on the Chinese package insert does not match the technical information provided, or not completely and accurately translated according to the original package insert.

 


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