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Pharmaceutical & pharmacy licensing

KF94 Health Mask Quasi-Drug Product Approval — 15-Day Manufacturing Report and 55-Day Product Approval Processing Period

Health masks intended to protect the respiratory tract from particulate hazards such as yellow dust and fine dust or from infectious agents are quasi-drugs designated by the Ministry of Food and Drug Safety. To manufacture them, you must equip the required facilities and file a manufacturing report with the Regional Office of Food and Drug Safety under Article 31(4) of the Pharmaceutical Affairs Act, and at the same time apply for product approval or file a product report for at least one product. The processing periods stated on the official forms are 15 days for the manufacturing report and 55 days for product approval requiring review of specifications and test methods. A person who acquires the business must file a succession report within 1 month under Article 89(3) of the Act.

Written by Hwang Yunsang, Administrative Agent · Published 2026-10-27 · Updated 2026-10-27

Procedure

Procedure type
  • Notification Difficulty Low

    You submit the statutory report form and required documents. Once the documents are in order the report is accepted; for some reports the authority checks the contents before accepting it.

  1. 1. Confirm the product is a health mask and choose the KF grade

    The Designation of the Scope of Quasi-Drugs notice divides masks into surgical, health and droplet-blocking masks, and defines products intended for respiratory protection as health masks. Health masks must state KF80, KF94 or KF99 in parentheses in the product name, so decide the target grade first.

  2. 2. Prepare the manufacturing facility and manufacturing manager

    The manufacturing site must have a work area, a test laboratory for quality control of raw materials and products, a storage area, and the facilities and equipment needed for manufacturing and quality control. A quasi-drug manufacturer that makes only masks may appoint a technician approved by the Minister of Food and Drug Safety instead of a pharmacist as manufacturing manager, and the processing period for that approval is 7 days.

  3. 3. File the manufacturing report and product approval application together

    Submit the quasi-drug manufacturing report, with the representative's medical certificate and the manufacturing manager's qualification documents, to the Regional Office of Food and Drug Safety. Under Article 2(3) of the Enforcement Rule on the Safety of Pharmaceuticals, etc., you must apply for product approval or file a product report for at least one product at the same time.

  4. 4. Prepare the product approval application data

    State the raw materials and their quantities, appearance and structural drawing, manufacturing method, and specifications and test methods, and attach the test reports issued by a testing institution. Products applied for the first time must include facial leakage rate test results, with limits of 25.0% or less for KF80, 11.0% or less for KF94 and 5.0% or less for KF99. Whether the product can proceed by product report must be checked against the specifications and test methods or standard manufacturing standards notified by the Ministry.

  5. 5. Change reports, succession and release control

    To change reported matters such as the site location or representative, file a change report, and if you acquire the business, file a succession report within 1 month. The manufacturer must release only products that passed quality testing and must state the items required by Article 65 of the Pharmaceutical Affairs Act, such as the word "quasi-drug", the manufacturing number and the expiry date, on the container or package.

Required documents

  • Quasi-drug manufacturing report (Enforcement Rule on the Safety of Pharmaceuticals, etc., Form No. 2)
  • Application for manufacturing/import product approval of pharmaceuticals, etc. (Form No. 4 of the same Rule) or product report (Form No. 6)
  • Application for manufacturing manager approval (Form No. 43 of the same Rule) with degree and career certificates
  • Physician's medical certificate confirming the representative does not fall under Article 5(1) or (3) of the Pharmaceutical Affairs Act
  • Data on raw materials and their quantities, appearance (exterior photos and structural drawing), and manufacturing method
  • Specifications and test methods data with test reports from a testing institution
  • Facial leakage rate test results (for products applied for the first time)
  • Draft container and package labeling (including the KF grade in the product name)

Fees

Administrative service fee
  • from KRW 300,000
All administrative service fees exclude 10% VAT.

Fees for the manufacturing report, product approval application and manufacturing manager approval are paid in the amounts notified by the Minister of Food and Drug Safety, and testing institution costs are separate. Our office fee starts from the amount shown above and may vary depending on whether it is a new report or a change or succession and on the number of products; we will give you an exact quote after reviewing your documents.

See fees and official charges for this service →

Legal basis and review date

  • Pharmaceutical Affairs Act Article 2(7)
  • Pharmaceutical Affairs Act Article 31(4)
  • Pharmaceutical Affairs Act Article 36(2)
  • Pharmaceutical Affairs Act Article 65
  • Pharmaceutical Affairs Act Article 89
  • Enforcement Rule on the Safety of Pharmaceuticals, etc. Article 2
  • Enforcement Rule on the Safety of Pharmaceuticals, etc. Article 4
  • Enforcement Rule on the Safety of Pharmaceuticals, etc. Article 8
  • Enforcement Rule on the Safety of Pharmaceuticals, etc. Article 42
  • Enforcement Rule on the Safety of Pharmaceuticals, etc. Article 48
  • Enforcement Rule on the Safety of Pharmaceuticals, etc. Article 103
  • Enforcement Decree on Facility Standards for Manufacturers and Importers of Pharmaceuticals, etc. Article 3
  • Designation of the Scope of Quasi-Drugs (Ministry of Food and Drug Safety Notice)
  • Regulation on Approval, Notification and Review of Quasi-Drugs Articles 5 and 7

Checked against the statutes on

Statutes and public notices change, so each case needs to be checked individually. Statute titles are given in English for reference. The Korean statutes are the authoritative text.

Check these first

  • Facial leakage rate test data are required for products applied for the first time, and for package products that differ only in size, test data for 1 product may be submitted.
  • To state "close-fitting" in the product name, data confirming the fit must be submitted separately at the first application.

Frequently asked questions

Do I need Ministry of Food and Drug Safety approval to make and sell KF94 masks?
Yes. Health masks are quasi-drugs designated under Article 2(7)(a) of the Pharmaceutical Affairs Act, so you must file a manufacturing report under Article 31(4) of the Act and obtain product approval or file a product report for each product. The product name must state the applicable grade, KF80, KF94 or KF99, in parentheses.
Can I file the quasi-drug manufacturing report first and apply for product approval later?
No. Article 2(3) of the Enforcement Rule on the Safety of Pharmaceuticals, etc. requires a person filing a quasi-drug manufacturing report to apply for product approval or file a product report for at least one product at the same time. The manufacturing report and the product application data are therefore prepared together.
Does the manufacturing manager for masks have to be a pharmacist?
No. A manufacturer that makes only items under Article 2(7)(a) of the Pharmaceutical Affairs Act, such as masks, appoints a technician approved by the Minister of Food and Drug Safety under Article 36(2) of the Act. A person with a bachelor's degree from a 4-year program in natural sciences, engineering or medicine, or with the quasi-drug manufacturing experience set for each education level, is eligible for approval (Article 42(2) of the same Rule).
Can I use the equipment of an industrial mask factory as a quasi-drug manufacturing site?
Yes, under conditions. Article 3(2) of the Enforcement Decree on Facility Standards for Manufacturers and Importers of Pharmaceuticals, etc. allows facilities for other goods to substitute for the quasi-drug site if they meet the facility standards for work area, test laboratory and storage and there is no risk of cross-contamination with the quasi-drugs. You must be able to show in documents how the processes and storage areas are separated.
If I take over a health mask factory, do I need a new approval?
No, you file a succession report instead. Under Article 89 of the Pharmaceutical Affairs Act, a person who acquires the business succeeds to the status of the manufacturer and the product approval holder and must file a succession report for manufacturers, etc. (Form No. 75) with documents proving the transfer within 1 month. Succession does not occur if the acquirer falls under the disqualification grounds of Article 31(8) of the Act.
Can an administrative agent handle a health mask approval application?
Yes. Hwang Yunsang Administrative Agent Office prepares the quasi-drug manufacturing report, the product approval application or product report, and the manufacturing manager approval application, organizes the attachments including testing institution reports, and submits them on your behalf. We also prepare and submit supplementary data, change reports and succession reports.

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This guide is general information based on public sources. Requirements, documents and deadlines differ by case and by the competent agency, so please confirm them before you proceed.