License maintenance is an important consideration for manufacturers selling medical devices in South Korea as failures to comply could lead to loss of market access, revocation of approval, suspension of business activities and administrative sanction fines that can significantly affect sales. License Maintenance in South Korea is specified in Article 12 Paragraph (1) – Amending Approvals or Certifications of the Medical Device Act. Manufactures must obtain approval or certification to file an amended report to the Ministry of Food and Drug Safety (MFDS) in the case of any changes to the specifics of the license or certification, including the change in location of the manufacturer.
Contact Asia Actual with any medical device license amendment questions in South Korea. Our local, bi-lingual regulatory experts are well positioned to assist.