COMPANY PROFILE

Regulatory Assessment Report

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.

  • Product Classification
  • Required Data List for registration / notification / approval
  • Regulatory Roadmap
  • Conclusion
 
Notification/Registration/Approval

COMVALIS provides notification/registration/approval and import EDI services for imported cosmetics, functional cosmetics, quasi-drugs, and medical devices.

Labeling Compliance

COMVALIS offers regulatory labeling services in accordance with MFDS regulations.

  • Medical Device Labeling
  • Cosmetics Labeling
  • Functional Cosmetics Labeling
  • Quasi-drugs Labeling
Quality Testing

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.

Visit MFDS

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.