04
Health Functional Food
Bringing evidence-based functionality to market
From classification of health, functional, and novel foods through ingredient safety, functional efficacy, GMP, labeling, and post-market surveillance — 9-step consulting that meets both MFDS and global standards.
What we offer
Health Functional Food
Functional Food Licensing
Classification of health functional, functional, and novel foods, plus MFDS licensing consulting.
Individually-recognized Ingredients
Safety and functionality dossier preparation and recognition application for individually-recognized health functional food ingredients.
Notified Ingredients Registration
Registration and labeling standard consulting for notified-type health functional food ingredients.
GMP Certification
GMP certification consulting for health functional foods and pre-audit of manufacturing facilities.
Labeling · Advertising Review
Pre-review of functional food labeling and advertising; guideline advisory.
Consulting Process
A 9-step standard process from classification through post-market surveillance
Product Classification
Determine whether the product is a health/functional food or a general food. Distinguish among health supplement, functional food, and novel food frameworks.
Ingredient · Safety Evaluation
Verify all ingredients comply with regulatory standards. Avoid prohibited/restricted substances; toxicity and allergenicity testing for new ingredients.
Evidence of Functionality
Functional benefit substantiation through efficacy studies. Compilation of clinical and human-application study data.
GMP Compliance
Verification of compliance with health functional food GMP and certification preparation.
License Documentation
Consolidated preparation of all dossier packages required for licensing.
Submission
Submission to MFDS. Review response and deficiency handling.
Review · Approval
Monitoring of review progress, additional data submission, and approval acquisition.
Labeling · Packaging
Mandatory labeling, nutrition info, warnings, multilingual label compliance verification.
Post-market Surveillance
Post-sale adverse event monitoring, periodic reporting, and post-license variation notifications.
If the first step feels difficult
The first decision in regulatory consulting matters most. Book a free 30-minute consultation with MEDISOL to design the most efficient market entry path together.