Business reports & registrations

How to Report a General Health Functional Food Sales Business — 2-Hour Prior Training and Filing a Medical Device Sales Report Together

To sell health functional foods anywhere other than a pharmacy, you must report a general health functional food sales business to the head of the city, county, or district with jurisdiction over each business place, under Article 6(2) of the Health Functional Foods Act. You must complete 2 hours of safety and hygiene training before reporting, and the authority must notify you of acceptance within 3 days. If you also sell medical devices such as blood pressure monitors or thermometers, you file a separate sales business report under Article 17 of the Medical Devices Act with the same city, county, or district, and if you sell online you also check the mail-order business report requirement.

Procedure

  1. 1. Confirm your sales method and which report applies

    Selling health functional foods made by others in a store, through door-to-door sales, or online is a general health functional food sales business, while selling products made by a specialized manufacturer under your own brand is a distribution-specialized sales business that is reported separately. Pharmacies registered under the Pharmaceutical Affairs Act and customized health functional food sales business places do not file a general sales business report. If you also plan to sell medical devices, check at this stage whether the items are exempt from the sales business report.

  2. 2. Complete 2 hours of safety and hygiene training

    A person who intends to run a general health functional food sales business must complete 2 hours of safety and hygiene training before reporting (Enforcement Rule Article 19(3)). If you intend to run the same type of business within 2 years from the date of training, you do not need to take it again, and after opening you must complete 2 hours of training every year for each business place.

  3. 3. Check the facility standards for the business place

    An independent business place is the rule, but if it does not interfere with business, you may share another business place or keep only an office (Enforcement Rule Annex 1). For door-to-door, telephone solicitation, multi-level, e-commerce, or mail-order sales where buyers do not visit the office, a building used as a house may serve as the office. If you open a store, check before signing the lease that the use on the building register allows a retail store.

  4. 4. Submit the health functional food business report

    Submit the business report in Form No. 6 with proof of training to the business report department of the city, county, or district where the business place is located; you can also file through Government24. The authority checks disqualification grounds through shared administrative data and must notify acceptance within 3 days, and if no notice is given within that period, the report is deemed accepted on the day after the period ends. Once accepted, a business report certificate in Form No. 8 is issued.

  5. 5. File the medical device sales report and the mail-order business report together

    To also sell or rent medical devices such as massage chairs, blood pressure monitors, or thermometers, submit a separate medical device sales (rental) business report in Form No. 36 for each business place to the same city, county, or district; the processing period is 3 days and no attachments are prescribed for the reporter. A person who has filed a sales business report does not need to file a rental business report again. If you sell online, also check whether you must file a mail-order business report under Article 12 of the Act on Consumer Protection in Electronic Commerce.

Required documents

  • Health functional food business report (Enforcement Rule of the Health Functional Foods Act, Form No. 6, with 'general health functional food sales business' checked as the business type)
  • Proof of completing safety and hygiene training (if taken in advance; may be omitted if the official can verify it directly)
  • For a foreign reporter, documents from the home country confirming no disqualification grounds (with consular confirmation or an apostille)
  • For business inside a pleasure boat or ferry terminal, military facility, or railway or urban railway station, the relevant license, use permit, or use contract
  • Medical device sales (rental) business report (Enforcement Rule of the Medical Devices Act, Form No. 36, if you also sell medical devices)
  • Corporate registration certificate (for corporations; verified by the official through shared administrative data)
  • Report fees (health functional food business report: 25,000 won online, 28,000 won in person; medical device sales business report: 9,000 won online, 10,000 won in person)
  • Letter of authorization (if an administrative agent submits on your behalf)

Fees

Generally in the range of tens of thousands to a few hundred thousand won. We provide a quote after consultation based on the sales method (store or online), whether the medical device sales report and mail-order business report are filed together, and the number of business places. Government report fees and training fees are separate.

Legal basis and review date

  • Health Functional Foods Act, Article 4
  • Health Functional Foods Act, Article 6
  • Health Functional Foods Act, Article 9
  • Health Functional Foods Act, Article 13
  • Health Functional Foods Act, Article 44
  • Enforcement Decree of the Health Functional Foods Act, Article 2
  • Enforcement Rule of the Health Functional Foods Act, Articles 5, 6, 7 and 19
  • Enforcement Rule of the Health Functional Foods Act, Annex 1
  • Enforcement Rule of the Health Functional Foods Act, Form No. 6
  • Medical Devices Act, Article 17
  • Enforcement Rule of the Medical Devices Act, Articles 37 and 38
  • Enforcement Rule of the Medical Devices Act, Form No. 36
  • Act on Consumer Protection in Electronic Commerce, Article 12

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

  • If the trade name, representative's name, or business place location changes, file a change report (Form No. 13), and if you close the business, submit a closure report (Form No. 14) within 1 month from the closure date. The medical device sales business also requires separate change, suspension, and closure reports.
  • Health functional food sales operators must complete 2 hours of safety and hygiene training every year for each business place, so manage the training schedule after reporting as well.

Frequently asked questions

Do I need to file a report to sell health functional foods in a shop that is not a pharmacy?
Yes. Except for pharmacies and customized health functional food sales business places, you must report a general health functional food sales business to the city, county, or district for each business place. Operating without reporting is punishable by imprisonment of up to 5 years or a fine of up to 50,000,000 won (Article 44).
Do I need a business report if I only sell health functional foods on an online store?
Yes. Online sales are also subject to the general health functional food sales business report, and for mail-order sales where buyers do not visit the office, you can report a building used as a house as your office. The mail-order business report is determined separately under the Act on Consumer Protection in Electronic Commerce.
How many hours is the hygiene training for a general health functional food sales business?
The training before reporting is 2 hours. After opening, you must take 2 hours every year for each business place, and if you report the same type of business within 2 years from the date of training, it is deemed completed.
If I also sell blood pressure monitors and thermometers, do I need a medical device sales report?
As a rule, yes. Under Article 17 of the Medical Devices Act you file a sales business report with the city, county, or district for each business place, but condoms, blood glucose meters built into or combined with mobile phones or home appliances, and items designated by notice of the Minister of Food and Drug Safety may be sold without reporting (Enforcement Rule Article 38). Pharmacy founders and pharmaceutical wholesalers also do not need to report.
How long does the health functional food sales business report take?
You are notified of acceptance within 3 days. Both the health functional food business report and the medical device sales report have a 3-day notification period set by law, and if no notice or extension notice is given within that period, the report is deemed accepted on the day after the period ends.
Does an administrative agent handle the health functional food sales business report?
Yes. Hwang Yunsang Administrative Office reviews your sales method and business place facilities, prepares the health functional food business report and the medical device sales (rental) business report, and submits them to the city, county, or district on your behalf. The safety and hygiene training must be completed by the business operator (or a designated responsible person) in person.

Contact us

Hwang Yunsang Administrative Office in Songdo, Incheon prepares and submits administrative documents and explains the procedure. If your situation is similar, send us a message.

📍 2697, 26F POSCO Tower-Songdo, 165 Convensia-daero, Yeonsu-gu, Incheon, Republic of Korea · 📞 010-3374-2687 · 🌐 hwangadmin.com

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.