Apply for only one product name per application. Please handle separately for products with different names under the same classification and class.

Principles of drafting Chinese/English product names:

1. Do not use the medical device trademark or firm name of others (unless the trademark has been obtained or authorized for use)
2. The product name of the medical device shall not be identical to that of another medical firm’s product, nor should it involve imitation or allusion.
3. There shall not be falsehood, exaggeration, or improper association or confusion about the medical device and its effectiveness.
4. 4. Chinese product names shall not contain foreign characters or numbers.

For the foreign language product name of an imported medical device, please draft it based on the manufacture and free sale certificate of the country of origin, instruction manual of the original manufacturer, and actual product effectiveness; for the Chinese product name of a domestic medical device, please draft it based on the actual effectiveness.

It is not advisable to use generic names for Chinese and English product names to avoid similarities with product names of other medical device firms. The firm’s name, trademark name, or brand name can be added in front of the product name to indicate distinction. When using the trademark of another firm’s medical device or the name of the firm, an original certificate of authorization for use shall be attached.

The name and address of the medical device firm shall be stamped. Please fill in the category column with the medical device classification number announced by the Ministry of Health and Welfare, and also properly fill in the effectiveness section.

Principles of splitting an application:

Where the products have the same medical device classification number, identical product name, manufacturer, and intended use, but only differ in their model numbers, they may be combined in the same application for registration and market approval and registered under the same license. If the accessories of an instrument are Class 2 or 3 medical devices announced by the Ministry of Health and Welfare and are not exclusive accessories for the proposed device (e.g., ultrasound gel, universal self-adhesive electrodes, and EEG needle electrodes), they shall be filed as a separate application for registration and market approval.