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Food and Drug Administration

Instructions of the License Application

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Principles of Drafting Chinese/English Product Names and Application Form

【Update Date：2022-07-07】unit：醫療器材及化粧品組

    Only one product name is applied in one registration case. Products with same class and category but different names should be applied in different registration cases.

    Principles of drafting both Chinese and English product names:
1. It shall not use the medical device trademark or firm name of others. However, this shall not apply when said product has obtained the trademark or the use has been authorized.
2. It shall not be the same as or similar to the medical device product name of other firms, thereby causing confusion with the medical devices of other firms.
3. It shall not involve any false or exaggerated statements, or lead people to have improper association or confusion on the intended use and effectiveness of medical device.
4. The Chinese product name shall not contain any characters in other language or any numbers. However, this shall not apply when the central competent authority deems that they have direct meaning or the English trademark has special meaning.
5. The Chinese and English product names of medical devices exclusively for export shall not be the same as the Chinese and English product names of medical devices that are sold domestically.
    The determination of medical device product names being the same or similar shall be decided based on the precedence of trademarks, company names, or other identifiable names.

    Regarding imported medical devices, English product names must be drafted according to the Free Sale Certificates, product labels, and products’ efficiency. For local medical devices, Chinese product names must be drafted based on products’ efficiency.

    It is not suitable to draft Chinese or English product names using generic names, in order to avoid similarity with other companies’ product names. It is an option to add the manufacturer name or the trademark in front of the product name to manifest the singularity of the name. The names of trademarks of other companies can be used only under the condition of authorization grant.

    The application form must involve the stamps of both company and representative, category, model number (specification), and the performance of product. The category can be determined based on the “Regulations Governing the Classification of Medical Devices.” The product performance must be filled out accurately.

    Products with the same classification category, product name, manufacturer, and purpose, but with different model numbers, may be applied in one registration case and registered on the same certificate. For example, the category of medical endoscopes and accessories involves many products (pins, tweezers, dissectors, scissors, aspiration/perfusion probes, etc.), with different product names and purposes, such as gastroscopes, colonoscopes, and resectoscopes, and their accessories should be applied in different registration cases.