The Taiwan Food and Drug Administration (TFDA), an agency under the Ministry of Health and Welfare, is tasked with the approval and oversight of food market access, sales operations, post-marketing compliance regulation and other relevant functions.
Official Website of the Regulatory Authority: https://www.fda.gov.tw/
Database Portal:http://consumer.fda.gov.tw/Food/InfoHealthFood.aspx?nodeID=162
Act Governing Food Safety and Sanitation
Health Food Control Act
Pursuant to Article 2 of the Health Food Control Act, health food refers to food products that deliver specific health benefits, are labeled or claimed to possess such benefits, must be supported by substantial scientific evidence, and shall not be intended for medical purposes such as disease treatment or therapy.
All health food products must pass the review and approval of the Taiwan Food and Drug Administration (TFDA) under the Ministry of Health and Welfare. Upon approval, the approved health benefit statements, the Health Food Mark (Little Green Man Mark) and the approval number shall be clearly marked on the product packaging.
Letter of Authorization
Good Manufacturing Practice (GMP) certification documents
Product formula, packaging, labeling and instructions for use
Stability test report and safety assessment report
Health benefit assessment report, functional ingredient test report and corresponding test methods
Manufacturing process, product hygiene inspection specifications and reports
General nutritional composition analysis report
English or Traditional Chinese
Application form (including product name, information of the applicant and manufacturer, etc.)
Specification and content list of product raw materials and ingredients
Product safety assessment report (pre-assessment of safety classification)
Product health benefit assessment report (scientific evidence supporting specific health benefits)
Functional ingredient verification report and inspection methods
Functional ingredient stability report
Summary / flowchart of manufacturing process
Drafts of labeling, packaging and instructions for use
Test samples and relevant inspection reports
Others: GMP certificate, Free Sale Certificate (for imported products), authorization documents, etc.
1.Registration Procedure
Ingredient & Labeling Review--Registration Documentation Preparation--Submission for Review & Approval--Registration Approval
2.Registration Timeline and Official Fees (Currency: New Taiwan Dollar, TWD)
The current inspection and registration application system for health food adopts a two-stage review and charging mechanism:
Preliminary review fee: NT$160,000
Secondary review fee: NT$340,000
Certificate issuance fee: NT$2,000
The preliminary review takes 60 working days, and the secondary review takes 180 working days, excluding the time allocated for the applicant to submit supplementary materials.
A：According to Wiselink's experience, it currently takes about 2 weeks to approve.