Save your company thousands of hours and dollars before your company enter the Korean market. Your company need to thoroughly review the regulations. We include the following in the Regulatory Assessment Report.
Required Data List for registration / notification / approval
COMVALIS provides notification/registration/approval and import EDI services for imported cosmetics, functional cosmetics, quasi-drugs, and medical devices.
COMVALIS offers regulatory labeling services in accordance with MFDS regulations.
Medical Device Labeling
Functional Cosmetics Labeling
MFDS has its own safety requirements, even if your product has notified / registered / approved in the EU or other countries and has multiple data. Sometimes the required safety data of MFDS may be only available in Korea. COMVALIS will receive your product and request a test to the test lab. in Korea.
Translation of GMP documents
If your company need to translate GMP documents to be submitted to MFDS, our experts with GMP knowledge will be able to translate at a competitive price.
If your product is innovative and does not have a similar product, you may have difficulty notifying, registering, and approving it. We will visit the MFDS and arrange the meeting for you to check the necessary procedures and guide you with your questions.