22-2 · Cosmetics manufacturing & sales

Cosmetics Manufacturer Registration

To manufacture cosmetics or carry out filling and primary packaging, you must register as a cosmetics manufacturer with the head of the regional Food and Drug Administration having jurisdiction over the plant, under Article 3 of the Cosmetics Act and Article 3 of its Enforcement Rule. The registration requirements are the facility standards in Article 6 of the Enforcement Rule: a workroom protected against rodents, insects and dust, a storage room, and a laboratory with quality-inspection equipment. Facilities may be omitted if you only perform part of the process or outsource quality inspection to a qualified institution. A representative who falls under the disqualifications in Article 3-3 of the Act (a person with a mental illness, a person under adult guardianship, a narcotics addict, etc.) cannot register. Changes to the representative, trade name, location or manufacturing type must be registered within 30 days of the change.

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#Cosmetics Manufacturer Registration#Official check#22-2
🌐 How to Register a Cosmetics Manufacturing Business
01

Procedure

Procedure

Procedure type
  • 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.

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

02

Filing route

Filing route

Regional Food and Drug Administration having jurisdiction over the plant (including NEDRUG electronic filing)

Confirm the current filing office, jurisdiction, and online availability on the official website.

Official check
Actual processing agencyCompetent Korean authority or official service
Statutory and policy authorityMinistry of Food and Drug Safety
Online routeCompetent Korean authority or official service
03

Deadlines & processing notes

Deadlines & processing notes

Check deadlines and next steps against the notice, filing date, and any request for additional documents.Official check
04

Basic documents

Basic documents

Basic documents0 / 8

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.