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
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
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)