1. Certification Overview
In Taiwan, cosmetics are defined as products used on the outside of the human body, teeth, or oral mucosa to add shine to the skin and hair, stimulate the sense of smell, improve body odor, change appearance, or cleanse the body, and there are a total of 14 product categories.
As of July 1, 2024, Taiwan fully implemented a cosmetics registration system, applying the registration system to all cosmetics and making prior registration with the Taiwan FDA mandatory.
In addition, starting July 1, 2026, the completion of a PIF and compliance with GMP will be mandatory for all cosmetics.
2. Regulatory Agencies and Basic Information
| Regulatory Agencies | Taiwan FDA (Taiwan Food and Drug Administration) |
| Testing Agency | Super laboratory Bioresource Collectoin and Research Center TCI GENE |
| Lead time / Price | Varies by product |
| Agent | Designation of a representative in Taiwan is mandatory |
3. Registration Process
- Designation of an agent in Taiwan for product registration with the Taiwan FDA
- Preparation for product registration (label, packaging design, product ingredient list, test reports, etc.)
- Preparation of GMP certificate (ISO 22716) for specific products
- Product Registration Application (Taiwan FDA Cosmetic Product Notification Platform)
- Creation and Storage of Product Information Files (PIF)
- The product is assigned a TFDA registration number and displayed on the label.
4. Required Documents
| Materials to be submitted for cosmetic registration | • Product Registration Number • Product Name in Chinese and English • Product Type and Use • Product Type, Series Product Model Number, and Color Code • Product Capacity • Product Precautions • Name, Address, and Phone Number of the Product Manufacturer or Importer • Name, Address, Nationality, and Other Good Manufacturing Practice (GMP) Standards of the Manufacturing Site • All Ingredients, and Weight or Volume Percentage Indicating Content in Case of Usage Restrictions Set by the Central Competent Authority (Taiwan FDA) • Other Related Descriptions |
| Cosmetic product information file | • Basic Product Information 1) Product Name 2) Product Category 3) Dosage Form 4) Use 5) Name and Address of Manufacturing Facility 6) Information on Product Manufacturer or Importer • Documentary Evidence of Completed Product Declaration • Full names and individual details of ingredients • Product outer packaging, container, label, or leaflet • GMP Compliance Certificate or self-declaration confirming that the manufacturing facility complies with Cosmetic GMP regulations • Manufacturing Methods and Procedures • Method of Use, Body Areas of Application, Dosage, Frequency, and Target Group • Adverse Effects of Product Application • Physical and Chemical Properties of the Product and Individual Ingredients • Toxicological Data of Ingredients • Product Stability Test Report • Microbiological Test Report • Antimicrobial Effect Test Report • Supporting Information for Functional Evaluation • Information on Packaging Materials in Contact with the Product • Product Safety Information 1) Conclusions and recommendations of the safety assessment with the signature and date of the signatory of the safety report 2) Certificate confirming that the signatory of the safety report complies with the qualifications specified in the ‘Regulations on the Management of Cosmetic Product Information Files’ |
5. Validity Period
- Validity Period: 3 years
- Renewal: Extend validity period 3 months prior to expiration