OMC Medical
OMC Medical

Cosmetics Registration in Taiwan

Regulatory Authority:

Taiwan Food and Drug Administration (TFDA)

Link for RA:

https://www.fda.gov.tw/ENG/index.aspx

Local regulation:

Cosmetic Hygiene and Safety Act

Who can register : 

  • Manufacturers
  • importers

Data to be communicated :

According to Article 4 of Regulations Governing Notification of Cosmetic Products, data notification specified in the preceding Article shall include:

  • Notification number of products. 
  • Chinese and English names of products provided that there is no need to notify the English name of domestic products. 
  • Category and usage of products.
  • Type of products: The model number and colour code for series products. 
  • Dosage of products. 
  • Precautions of products. 
  • Names, addresses and telephone numbers of manufacturers or importers of products. 
  • Names, addresses and nationalities of the premises where products are manufactured and other criteria conforming to cosmetics Good Manufacturing Practice (GMP). 
  • Full components of products. If the competent central authorities impose usage restrictions, the weight or capacity percentage defining its content inclusion is used.
  • Additional related descriptions. The data notification must be written in Chinese, English, numbers, or international symbols.

According to Article 3 of Regulations for Cosmetic Product Information File Management, a cosmetic product information file shall establish the following information in Chinese or English: 

  • Essential product information includes the product’s name, category, dosage form, purpose, the names and addresses of manufacturing facilities and information about the product’s manufacturers or importers.
  • Documents proving that the product notification was completed.
  • Full names of the Ingredients, as well as their contents.
  • The product’s outside packaging, including containers, labels, and leaflets.
  • Cosmetic Good Manufacturing Practice Regulations compliance certificates or self-declarations from manufacturing facilities.
  • Methods and techniques for manufacturing: Methods of use, body parts, dose, frequency, and the target population are all factors to consider.
  • Adverse effects of using the product:  The physical and chemical properties of the products and the individual constituents.
  • Ingredients’ toxicological information:  The results of the product stability tests. The results of the microbiological tests.
  • The results of the antimicrobial efficacy tests.
  • The functional assessments’ supporting information.
  • Details on the packing materials that come into contact with the products. 
  • Product safety information:
    • Safety evaluation conclusion and suggestion which has the signature of the signatory for the safety report and the date. 
    • Qualification certificates which the signatory for the safety report complies with Articles 4, 5 and 6.

Process:  

Cosmetic companies can use the TFDA’s online notification system https://cos.fda.gov.tw/TCAL/ to notify their products and print notification certificates. Applicants must first contact the TFDA to receive a system account and password before proceeding with the notification. For the time being, internet notifications are free of charge.

Timeframe and fees: 

  • Review fee charged for cosmetics notification – NT$600 per application.
  • Review fee charged for modification of cosmetics notification – NT$600 per application.
  • Review fee charged for extension of cosmetics notification – NT$600 per application.
  • Review fee charged for animal testing for the safety assessment of cosmetics or cosmetic ingredients – NT$40,000 per application.
  • For reissuing or renewing approved documents of animal testing for the safety assessment of cosmetics or cosmetic ingredients – NT$4,000 per application.  

Additional information:  

The validity period for product notification is three years. 

If any of the information mentioned above changes, the PIF must be updated as soon as possible. Both Chinese and English versions of the PIF are allowed. However, if the original version is not in one of the two languages, a translation in one of the two languages is necessary.

When the product is first sold, the maker or importer must keep the PIF (hardcopy or electronic) for at least five years for future inspections. The competent authorities will provide the company with seven days’ notice before checking the PIF in most cases.