Chapter 1 Taiwan TFDA regulatory information brief

1. Eaa and Introduction

Taiwan Food and Drug Administration，TFDA Responsible for approving and supervising market access, sales and post-marketing compliance of food products.

2. Supervision and regulation

Food Safety and Hygiene Administration Law

Health Food Management Act

3. Definition and classification of health food in Taiwan

According to the definition of Article 2 of the Health Food Administration Law, a health food is a food that has a specific "health effect" and is labeled or declared to have such effect, and must have substantial scientific evidence, and should not contain medical treatment, treatment of disease and other medical effects.

"Health food" must pass the examination of the Food and Drug Administration of the Ministry of Health and Welfare, and must be marked on the product package with the approved health efficacy statement, health food label (little green man label) and certificate number.

4. Entry requirement

• Power of attorney

• GMP（Evidence of good practice）

• Formulations, product packaging, labels, instructions

• Stability report, safety assessment report

• Health efficacy assessment report, efficacy component test report and test method

• Process, product health inspection specifications and reports

• General nutrient analysis report

5. Language of record 

English, or traditional Chinese

Chapter 2 Filing process & cycle & Government fee

1. Filing process

2. Filing cycle and official fees（Currency: New Taiwan Dollar）

At present, the application for health food inspection and registration is a two-stage review and charging system: the first review. Ten thousand yuan, reexamined. Ten thousand yuan, plus a license fee of 2,000 yuan.

The number of days for the first review is 60 days, and the number of days for the review is 180 days, excluding the time for the manufacturer to make up the parts.

Chapter 3 FAQ 

Q：If the product has more than 2 health food health benefits, can I apply for health food inspection registration at the same time, and do different health effects have different health food license numbers?

A：1. Consider products with different health efficacy or specifications standards, need different professional review content, according to article 4 of the licensing measures, the central competent authority for each health food inspection registration case only accepts the product application for a single health efficacy or specifications of the inspection registration case is limited.

2. If the health food obtains the health benefits above item 2, the health benefits items and statements will be added to the registration content of its license, and the same health food license number is used, and no other approved number is issued.

Q：What is the number and time limit of health food license extension, inspection and registration content change, transfer, replacement and replacement? 

A：In accordance with the provisions of Article 32 of the licensing measures, the health food license extension, change and transfer registration and replacement and replacement of documents and information recognized by the central competent authority are incomplete, the manufacturer shall make corrections within one month after receiving the notice from the central competent authority; If necessary, it may apply for an extension of one month, and it is limited to one time. If no rectification is made by the time limit, it shall be rejected.