Procedure
Procedure
- Registration Difficulty Medium
The authority checks whether the statutory registration requirements, such as facilities, staff and capital, are met before issuing a registration certificate. Registration can be refused if the requirements are not met.
- 01
Define the manufacturing scope: Under Article 2 of the Enforcement Decree, decide whether you manufacture directly, manufacture on consignment, or only do primary packaging. Filling and dividing bulk also count as primary packaging, so the required facilities and registration type depend on the scope.
- 02
Check the site and building use: Before signing a lease, confirm the building use in the building register, permitted industries if it is a knowledge industry center, and water supply, drainage and ventilation. Ask the local government whether container-washing water requires a wastewater facility report.
- 03
Lay out facilities and prepare the facility statement: Following Article 6 of the Enforcement Rule, mark the workroom (pest and dust protection, workbenches, powder removal equipment), storage room and laboratory on a floor plan and prepare the facility statement. If quality inspection is outsourced, omit the laboratory and prepare the consignment contract.
- 04
Prepare disqualification medical certificates: Obtain a physician's certificate that the representative is not a person with a mental illness and not a narcotics addict. A person with a history of mental illness needs a specialist's certificate that they are suitable to be a manufacturer.
- 05
Submit the registration application: Submit the Form No. 1 application with the certificates and facility statement to the regional Food and Drug Administration having jurisdiction over the plant, including through the NEDRUG electronic filing. The administration checks the corporate registry certificate through shared administrative information.
- 06
Receive the certificate and keep up duties: Once requirements are confirmed, the administration enters the registration and issues the Form No. 2 registration certificate. Afterwards, follow the duties in Article 11 of the Enforcement Rule such as keeping manufacturing and quality records, file change registrations within 30 days, and report suspension or closure on Form No. 11.
Filing route
Filing route
Confirm the current filing office, jurisdiction, and online availability on the official website.
Official checkDeadlines & processing notes
Deadlines & processing notes
Basic documents
Basic documents
화장품제조업 등록신청서(별지 제1호서식)
Many applicants finish the lease and interior work and then find the building use or workroom layout does not meet the standards, so confirm these before signing the lease.
Scope of services
Scope of services
Hwang Yunsang Administrative Agent Office prepares and translates documents for administrative agencies, submits them on your behalf, and guides you through permit, application, and notification procedures. Services that require the principal’s personal appearance, principal’s application, or electronic signature may be limited in delegation.
