Table of Contents
- What Is a Responsible Distributor?
- Difference from Manufacturer Registration
- MFDS Requirements
- Required Documents
- Application Procedure
- Post-Registration Duties
- FAQ
1. What Is a Responsible Distributor?
Under Korea's Cosmetics Act, a responsible distributor (책임판매업자) is the entity legally responsible for ensuring a cosmetic product's safety, labeling, and compliance before it enters the Korean market.
2. Difference from Manufacturer Registration
- Manufacturer: physical production facility, GMP required
- Responsible Distributor: brand/distributor responsible for product safety and market compliance — can source from manufacturers
- One company can hold both registrations
3. MFDS Requirements
- Must designate a Quality Control Manager with relevant qualifications
- Must establish a product quality management system
- Must maintain product safety data sheets for all marketed products
4. Required Documents
- Responsible distributor registration application
- Quality Control Manager's qualification documents
- Business registration certificate
- Facilities description (office is sufficient; no manufacturing facility required)
5. Application Procedure
- Submit application to regional MFDS office
- Document review (approx. 7–14 business days)
- Registration certificate issued
- Report each product to MFDS before launch
6. Post-Registration Duties
- Report adverse events to MFDS within 15 days
- Maintain product labeling in Korean
- Annual quality management review
- Notify MFDS of any changes to key personnel or business details
FAQ
Q. Can a foreign company be a responsible distributor in Korea?
A. Yes, but the foreign company must designate a Korean legal entity or agent as the registered responsible distributor in Korea.
Q. Do I need a separate registration for each product?
A. No. One responsible distributor registration covers all products. However, each product must be reported to MFDS before sale.
Register as a Cosmetics Responsible Distributor
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