Quasi-drugs Certification


The term "Quasi-drugs" means any of the following commodities:

  • Textile, rubber products or similar things used for the purpose of treating, reducing, treating, or preventing diseases of persons or animals
  • Something similar to something that does not have a weak or direct effect on the human body, and is not a device or machine
  • Sanitizer used for sterilization, deinsectization, and similar purposes to prevent infectious diseases
Applied Product

Article 1 나.clase in accordance with [Designation of Scope of Quasi-drugs].

  • Surgical mask: Products used for the purpose of preventing infection during medical treatment, treatment, or surgery
  • Health masks: Products used for the purpose of protecting the respiratory system from particulate harmful substances, such as yellow dust and fine dust, or sources of infection
  • Masks for preventing smear: Products used for the purpose of preventing smear infections in daily life
Certification Procedure
Certification Preparation

1) Application form
2) Data on representatives
3) Copy of manufacturing manager's approval or pharmacist's license
4) A copy of the corporate register
5) Building registration register
6) Facility details
7) One or more manufactured and sold (imported) item reports or applications for item permission;
= Manufacturing permit 25 days + due diligence 30 days (Manufacturing permit processing period is 55 days)