According to the “Medical Devices Act” Article 32, medical device firms that manufacture or import medical devices shall attach labels in Chinese to the smallest packaging unit for sale and provide Chinese instructions before engaging in the sale, wholesale, and retail. However, this shall not apply to those announced or approved by the central competent authority due to the difficulty in compliance.

    Registration application documents must include two copies of draft labels, instructions or packaging. The following particulars shall be indicated on the labels, instructions, or packaging of medical devices:
1. Product name.
2. License number or listing number.
3. Effectiveness, intended use, or indications.
4. Date of manufacture and shelf-life or expiration date.
5. Model number, specifications, or major components.
6. Warnings, cautions, use limitations, or expected and foreseeable side effects.
7. Name and address of the license holder or the person who completed the listing.
8. Name and address of the manufacturer.
9. Lot number or serial number.
10. Other particulars that shall be indicated as announced by the central competent authority.

    For specific medical devices announced by the central competent authority, the instructions set forth in the preceding paragraph may be replaced by electronic instructions.

    The labels, instructions or packaging can be arranged by the rule listed as below: the smallest package labels, Chinese labels, and Chinese instruction leaflet. Notably, all the labels must be stuck on the form of medical device, instructions or packaging paste sheet.

    In addition, upon collecting the license, the other two copies of the labels and instruction manuals must be provided based on the label and instruction draft approved by the TFDA.

    The smallest package label may be the original. If many models have the same label form, it is permitted to attach the representative label. If the size of the outer box label is too large, a photo of the label may replace it. The Chinese product name, lot number, manufacturing date or shelf life, certificate number, manufacturer name and address and product importer’s name and address must be printed on the Chinese label. If the product is condom, sanitary pad, sterilized or implanted product, or in vitro diagnostic reagent, both date of manufacture and shelf-life or expiration date must be printed on the Chinese label.
 
    Preparation of Chinese Instructions:
The Chinese instructions must be written mainly in Chinese in A4 format. The contents may include product description, indications/intended use (or purpose and function), warnings or precautions, side effects or complications, contraindications, model number and specifications. If the product involves accessories, the model number, quantity, and specification of accessories shall also be prepared. Contraindications, warnings, side effects and precautions must be accounted in detail and accurately, printed in rubic or boldtype font, or highlighted with a red frame. Font type on the Chinese instructions shall not be smaller than 7-pt. All the foreign language word size shall be smaller than Chinese words.

    For imported products, the contents of Chinese instructions must be based on the translation of original manufacturer’s instructions, which must be attached in the registration documents. The original manufacturer’s instructions involve catalogs, instructions for use, or operator’s manual. If the original manufacturer’s instructions are thick, please use tags to highlight the translation basis parts. Not all the contents of original manufacturer’s instructions must be translated. Only important information such as indications, warnings and precautions, specifications, model names, etc., must be translated and listed on the Chinese instructions.

    Principles for preparing labels and instructions must follow the latest proclamation.

For more information, please find the announcement below.
1.Principles of drafting Chinese instructions of medical devices (Chinese only) 醫療器材中文說明書編寫原則
2.Principles of drafting Chinese instructions of In Vitro Diagnostic Device (Chinese only) 體外診斷醫療器材中文說明書編寫原則