Recently, the Korean Ministry of Food and Drug Safety (MFDS) issued new device renewal requirements. For renewals, the medical device in Korea cannot have had any serious adverse events, and there needs to be a production or import track record and documentation. Required information for renewal should be presented.
Renewal applications must be submitted 180 days before the five-year period ends. Information required includes – information that shows that the medical device has continuously been effective, safety data are strong and consistent, the original import or manufacturing licenses, as well as several other items.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.