Table of Contents
- Cosmetics Manufacturing Regulation Overview
- Who Must Register
- GMP Facility Requirements
- Required Documents
- Application Procedure
- Post-Registration Obligations
- FAQ
1. Cosmetics Manufacturing Regulation Overview
Cosmetics manufacturing in Korea is regulated under the Cosmetics Act. Both the manufacturer (제조업) and the responsible distributor (책임판매업) must be registered separately with the MFDS.
2. Who Must Register
Any company that manufactures cosmetics products in Korea (including OEM/ODM manufacturers) must register as a cosmetics manufacturer. This applies regardless of whether products are sold domestically or exported.
3. GMP Facility Requirements
- Separate manufacturing zones for different product types
- Clean room or controlled environment for relevant products
- Quality control laboratory
- Raw material and finished goods storage
- Pest control and waste management systems
- GMP (Good Manufacturing Practice) documentation
4. Required Documents
- Cosmetics manufacturing registration application
- Facility floor plan
- Lease or ownership of manufacturing facility
- GMP compliance documentation
- Representative's ID
5. Application Procedure
- Prepare facility to meet GMP standards
- Submit application to the regional MFDS office
- On-site facility inspection
- Registration certificate issued (approx. 7–14 business days after inspection)
6. Post-Registration Obligations
- Maintain GMP records and product quality records
- Report any serious adverse events related to products
- Register individual product formulas with the MFDS (for domestic sales)
- Maintain separate cosmetics manufacturer and responsible distributor registrations
FAQ
Q. Can a foreign cosmetics company manufacture in Korea through a contract manufacturer?
A. Yes. The Korean contract manufacturer holds the manufacturing registration; the foreign company or its Korean entity holds the responsible distributor registration.
Q. Does this registration cover quasi-drugs (의약외품)?
A. No. Quasi-drugs require a separate pharmaceutical manufacturing or import license.
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