Legal basis: According to Article 5 of the Regulations Governing Categorization and Classification of Medical Device

Medical device firms or the public may make an inquiry to the central competent authority regarding the classification of medical devices or other relevant matters.

Inquirers of the preceding paragraph shall fill out an inquiry form, provide the following related documents and information, and pay the required fees for submission to the central competent authority:

Application fee: 3500 NTD/application.

Documents to be submitted:

1. Inquiry about the classification of a medical device

2. Instructions for use of the manufacturer: including operating instructions, function, and working principle. If they are not in the traditional Chinese or English version, a translation copy in traditional Chinese or English shall be provided as well.

3. Classification reference information: reference information from the United States of America, European Union, or other countries on the classification of the inquired product. If such reference information is not available, it is not required to be provided.

4. In addition to the above documents and information, when necessary, the central competent authority may request the inquirer to provide other relevant documents and information.

Note:

1. Applications that cover more than one product must be made separately.

2. Please refer to the latest announcements from the Ministry of Health and Welfare and the TFDA.