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End-to-End Regulatory Partner for Cosmetics in South Korea
Complete strategic Regulatory Service Provider for Cosmetics in South Korea
Artixio is a regulatory consulting company with presence in over 100+ countries and providing our clients with complete support throughout their products’ lifecycle journey. With our regulatory experts team, we offer effective strategies by reducing the time to launch a product in the market and maintaining post approval activities.
Cosmetics in South Korea
The department Cosmetics Evaluation Division in South Korea is responsible for review and evaluating quality, safety and efficacy of cosmetics products.
Artixio provides step-to-step guidance from conceptualization of the cosmetic product up to its successful launch and post marketing surveillance in compliance with the South Korea regulatory requirements.
As per South Korea, Functional Cosmetics are Cosmetics with functions such as aiding in skin whitening, improving skin wrinkles, etc.
A responsible seller who intends to manufacture or sell functional cosmetics by manufacturing or importing them must undergo an evaluation by the Minister of the Ministry of Food and Drug Safety (MFDS) or must submit a report to the Minister of the MFDS for safety and effectiveness of each product.
The procedure for evaluation of functional cosmetics as per the MFDS is as follows
The data requirements for submission are as follows
Data that verify safety, effectiveness or function
- Data concerning the origin and details of R&D
- Data concerning the safety
- Data that verifies effectiveness, or function
- Sun Protection Factor (SPF), waterproof Sun Protection Factor (SPF), and Protection Factor of UV-A (PA) data
Data concerning the standards and test methods (including samples)
Artixio offers following services
- Strategic pre-registration guidance according to MFDS requirements
- Guidance for Successful registration of the product in South Korea Market
- Easy market access strategies by reducing the time to product launch
- Handling Health Authority queries
- Post-Approval maintenance of the product
Why Artixio
Effective product launch strategies
Provides guidance in compliance Health Authority requirements
Successfully commercialized 500+ cosmetic brands worldwide
A team highly experienced in life cycle management
Global reach in over 120+ countries
FAQs
What is the review time for evaluation of cosmetics by South Korea?
South Korea takes 60 days to review cosmetic products.
What are the fees to request evaluation of functional cosmetics in South Korea?
Fees to request for evaluation of functional cosmetics in South Korea is as follows:
Electronic civil petitions – 189,000 KRW
By mail, in-person – 210,000 KRW
KRW: South Korean Won
Electronic civil petitions – 189,000 KRW
By mail, in-person – 210,000 KRW
KRW: South Korean Won
Do you provide documentation services for cosmetic product registration in South Korea?
Yes, we do provide advisory, scientific support and writing as per the regional requirements of South Korea.
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