Health supplement is regulated by MFDS and divided into two categories: generic health functional food (HFF) and product specific HHF.
HFF Code includes all the functional ingredients that can be used in generic HFF, and if product contains only functional ingredients in the Code it falls under generic HFF and no registration is required. But products need to comply with all Korean tests as specified in the Code. Marketing of HHF can be very quick as it doesn’t need registration/pre-marketing approval. However as MFDS test methods are different from Canadian/US methods companies are advised to test their products in a MFDS authorized lab in Korea before launching to ensure product will pass the tests at Customs when importing for the first time. Failing the quality tests will lead to stricter monitoring each time product is imported.
Product specific HHF includes functional ingredient(s) not described by the Code and therefore needs a full safety, efficacy, specifications, and health claims evaluation. The MFDS has 120 days to review the application. In certain cases, i.e., where the ingredient has been approved, review process may be expedited to minimum 90 days. If a product uses a product specific functional ingredient from the same manufacturer who has obtained the approval of the ingredient then no approval is further needed.
Cosmetic is regulated by MFDS and divided into two categories: general cosmetics and functional cosmetics. In order to import products to Korea both manufacturer and importer shall be registered, with the later as “marketing authorization holder”. Quality tests are conducted on the products but the tests performed differ based on the category of the product. Korea Pharmaceutical Traders Association (KPTA) is authorised by MFDS to conduct all import registration.
General cosmetics need to be registered with MFDS and are subject to post-market supervision. Functional cosmetics refer to those aiding in brightening skin, improving wrinkles, etc. and are subject to more stringent evaluation than general cosmetics. Functional cosmetics need to be registered with full evaluation of safety and efficacy. Once gaining approval, the manufacturer and importer are permitted to manufacture/import however, prior to marketing the products for sale, a second approval process must be undertaken.
NHP Consulting will provide all regulatory documentation to achieve market compliance for the South Korea marketplace