Registering a Health Food or Quasi-Drug Product?

Health functional foods and 의약외품 (quasi-drugs) run on two separate regulatory tracks — the Health Functional Food Act and the Pharmaceutical Affairs Act, respectively — but both sit adjacent to ordinary food and cosmetics manufacturing, and it's easy to register the wrong business type or miss a product-level step that a company-level license doesn't cover.

General Food Manufacturing Registration — the Baseline Reference Point

Before either specialized track, a plain food manufacturing/processing business (식품제조가공업) registration illustrates the baseline pattern both health functional food and quasi-drug registration build on: confirm the building's registered use matches a Category 2 neighborhood-living-facility classification for manufacturing (never residential use) before signing a lease or starting construction, clear the product against HACCP applicability, and confirm compliance with the full stack of adjacent laws (National Land Planning, Sewerage, Farmland, School Health, Outdoor Advertising, River, water-quality-protection, and noise/vibration laws, among others) via the local building department or the토지이음 land-use lookup site before installing equipment. Required documents: the registration application, a hygiene-training completion certificate, a health certificate, an approval opinion on other applicable laws, a groundwater quality test report (if using well water), and an LPG completion inspection certificate (if applicable) — a site inspection may happen before or after document submission depending on the local office.

Quasi-Drug Manufacturing: Two Legal Categories With Different Facilities and Managers

의약외품 (quasi-drug) is defined by the Pharmaceutical Affairs Act Article 2(7) in two parts that carry real regulatory consequences:

• 가목 (Category A) — fiber/rubber products used to treat, relieve, address, or prevent disease in humans or animals (e.g., surgical/health/splash-guard masks).
• 나목 (Category B) — products with weak or no direct action on the body that aren't instruments or machines (e.g., topical external disinfectants like hand sanitizer).

Facility standards differ by category. Category A follows a lighter facility standard (pest/dust barriers, a work bench, sterilization equipment when needed, hygienic storage). Category B follows the same facility rigor as pharmaceutical manufacturing — a dedicated water-supply system, pest/dust barriers, hygienic restrooms/changing rooms/handwashing stations, disinfection facilities (for sterile/liquid/ointment workshops), dust-removal equipment for powder-handling rooms, humidity control for hygroscopic products, and auto-temperature-controlled drying equipment where used.

Manufacturing manager qualifications differ by category too, and this is the detail most first-time applicants miss. Category B manufacturing requires a licensed pharmacist or herbalist pharmacist at each manufacturing site — no substitute qualification exists. Category A allows a tiered alternative: a physician, pharmacist, or 4-year science/engineering degree holder needs no further approval; a non-science-degree holder needs 2+ years of quasi-drug manufacturing experience; declining education levels require correspondingly longer experience, down to 4+ years for a high school graduate — but a Category A manager candidate without a pharmacist license must first obtain regional MFDS office approval as a qualified technician before manufacturing begins, not after.

Quasi-Drug Import Registration

Importing quasi-drugs manufactured overseas requires its own registration, distinct from manufacturing. No production facility is needed, but a business office and warehouse are mandatory, plus a test room (waivable if testing is outsourced under contract). Warehouse requirements include pest-control measures, cold storage and light-blocking facilities where applicable, and — critically — documented environmental monitoring: temperature/humidity is checked and logged daily, with written procedures for rodenticide/pesticide use and a documented basis for selecting any outsourced pest-control vendor.

Import manager (수입관리자) requirements mirror the manufacturing-manager split — Category A imports need at minimum a pharmacist or herbalist pharmacist; Category B imports (fiber/rubber products) allow the same tiered physician/pharmacist/science-degree/experience-based alternative as Category A manufacturing. The import manager must complete training within 6 months of starting the role (waived if trained within the prior 2 years) and 16+ hours every 2 years after, may not hold any other job duties concurrently, but — a useful efficiency — a company that both manufactures and imports at the same site can let its manufacturing quality manager also serve as import manager, provided that dual role is separately reported to the regional MFDS office.

Real Product Example: Sanitary Pads — Notification or Approval?

Sanitary pads are consistently the largest single category in Korea's annual quasi-drug approval statistics, and they illustrate the notification-vs-approval fork every quasi-drug product has to navigate:

• Product notification (filed with the regional MFDS office) applies when the product exactly matches a codified standard — listed in the Korean Pharmacopoeia or a recognized foreign pharmacopoeia (USP/NF, JP, BP, EP, DAB, Ph.F), an MFDS-notified standard/test-method item, or a product meeting an MFDS-notified standard manufacturing specification.
• Product approval splits further: MFDS headquarters reviews safety/efficacy for products that aren't identical in active ingredient, concentration, formulation, and indicated use/dosage to an already-approved product, use a genuinely new additive with no domestic precedent, or fall into specific flagged categories (portable oxygen/air products, insect repellents outside the standard specification, electronic/heated smoking-cessation aids). Regional MFDS offices handle approval for products that match an already-approved product's active ingredient, specification, and use but aren't eligible for simple notification. Required materials differ sharply between the two paths — notification needs proof the product meets the notified standard plus the test-method documentation (Korea's quasi-drug standards compendium is officially termed the Korean Quasi-drug Codex, KQC); approval needs the full safety/efficacy package (origin and development history, stability data, a full toxicology battery — single-dose, repeat-dose, reproductive/developmental, genetic, immune, carcinogenicity, and local toxicity — efficacy evidence, foreign-market usage history, and comparison against similar domestic products).

Health Functional Food Manufacturing: License, Not Just Registration

Manufacturing health functional foods requires an actual business license (not a lighter registration) from the regional MFDS office, in one of two forms: specialized manufacturing (전문제조업), manufacturing directly, or venture manufacturing (벤처제조업), where a certified venture company commissions a licensed specialized manufacturer to produce under contract. Required documents include the facility layout and major-equipment list, a quality-control-manager appointment filing, and (for venture manufacturing) the technical documentation on the functional ingredient plus the commissioned-manufacturing contract.

GMP facility requirements are extensive — the manufacturing site must sit a documented distance from contamination sources (livestock waste facilities, chemical-handling sites); the workshop must be physically separated from other uses, with clean zones and general zones divided by walls (not just a line on the floor) except where automation eliminates cross-contamination risk; floors need waterproof, crack-free, puddle-free finishing with proper drainage; interior walls need a bright, waterproof or antibacterial finish up to 1.5m; lighting needs to hit 220+ lux generally and 540+ lux in inspection areas; groundwater sources (if used instead of municipal water) must sit 20m+ from any contamination source; and a quality-control room needs dedicated test equipment unless testing is outsourced to an accredited lab or shared with a same-company facility. The company must also hold all 4 mandatory standard documents (product standard, manufacturing control, manufacturing hygiene control, and quality control documents) — the same 4-document structure as cosmetics CGMP — and complete operator training covering functionality/safety evaluation, GMP operations, and market conditions before the license issues.

Quality manager (품질관리인) qualifications run on the same tiered structure as other Korean regulatory-manager roles: a food-technology national certificate holder qualifies outright; a food-related bachelor's degree plus 1 year of experience; a non-food-related bachelor's plus 2 years; a related associate degree plus 2–3 years (depending on program length); a non-related associate degree plus 4 years; or a high school diploma plus 5 years. One quality manager is required per business site, must work there full-time, and has to be appointed before or simultaneously with the manufacturing license application — not after.

Health Functional Food Product Notification — A Separate Step After the License

The manufacturing license is a company-level approval (does the facility meet GMP standards); 품목제조신고 (product manufacturing notification) is a separate product-level filing confirming each specific product's formulation, manufacturing method, and specifications meet legal standards — required for every product listed in the Health Functional Food Codex or using a recognized individually-recognized ingredient, and also for repackaging bulk functional ingredients or finished capsules/tablets into smaller retail units (though pre-packaged consumer-ready product is excluded from this repackaging rule). No product can be sold until both the manufacturing license and its own product notification are complete. Required documents: the notification form, a manufacturing-method description with process flow and a shelf-life justification, an ingredient/content table stating functional-component amounts per daily serving, and quality test reports for the finished product and raw materials (export-only product is exempt). Filed with the regional MFDS office, for a KRW 20,000 stamp-duty fee, with a 7-business-day processing window — one of the fastest turnarounds across this office's regulatory practice areas.

Cited vs. Individually-Recognized Functional Ingredients — A Strategic Choice, Not Just a Filing

Whether a product's core ingredient is already listed in the Health Functional Food Codex (고시형, "cited") or not (개별인정형, "individually-recognized") determines both the regulatory path and the competitive positioning:

• Cited ingredients (vitamins, minerals, dietary fiber, and most common ingredients) are usable by any manufacturer meeting the codex specification, with no individual review — just the standard product notification. Fast to market, but with heavy price competition since every competitor can use the identical ingredient.
• Individually-recognized ingredients require the company to submit its own safety and efficacy data for MFDS review — typically 1–2+ years of research and human clinical trials — but grant something close to exclusive use of that specific ingredient once recognized, since a competitor generally needs a supply contract with the recognized company (or its ingredient supplier) to use it. This supports more specific, differentiated functional claims and premium positioning built around the research investment itself.
• Individually-recognized ingredients aren't permanently exclusive — once 6 years have passed since recognition and the ingredient has been used in 50+ product notifications with actual production history, it can be added to the Codex and becomes a cited ingredient available to everyone.

The Individually-Recognized Ingredient Approval Process

1. Define the target health claim (e.g., blood cholesterol, body fat reduction, sleep/fatigue improvement) and confirm the ingredient is genuinely differentiated enough to justify the individual-recognition route over a cited alternative.
2. Pre-screen for regulatory conflicts — confirm the ingredient isn't classified as a pharmaceutical substance, a hazardous substance of concern, or caught by novel-food restrictions — and design the required safety and efficacy studies.
3. Assemble safety data: acute/subacute/chronic toxicity and genotoxicity studies scaled to the ingredient's risk profile, plus dietary-history-based intake justification and allergy/interaction screening.
4. Assemble efficacy data — a human clinical trial is mandatory (randomized, double-blind, controlled design, with statistically significant results), typically supported by animal or in-vitro mechanism-of-action studies.
5. Set the ingredient's own specification (active-ingredient content, impurities, heavy metals, microbial limits, pesticide residue for plant-based ingredients) and validate the analytical test methods (HPLC, GC, etc.).
6. File the recognition application — original documents plus summaries, with a Korean translation required for any non-English source material, and a documented justification for any omitted data.
7. MFDS review runs through document screening, substantive expert-committee review, and any correction requests, targeting 120 days or less under the current streamlined process. A successful recognition comes with an ingredient recognition number, daily intake amount, approved functional claim language, and required precautions — published on the public data portal.