In early March, the Korean Ministry of Food and Drug Safety (MFDS) announced proposed amendments to the Standards for Medical Device Manufacturing and Quality Management. These amendments aim to speed up the process of granting compliance certification for medical devices. Under this system, the exporters of the device will be able to apply simultaneously for domestic Good Manufacturing Practice (GMP) certification and the Medical Device Single Audit Program (MDSAP) through newly introduced combined review mechanisms. This has been a joint scheme that many countries have adopted in order to ease the regulatory burden on device manufacturers and allow for quicker market entry. Furthermore, to speed up reviews, class 3 device GMP assessments will be delegated to specialized quality management review organizations. The MFDS invites public comments on the proposed amendments now.
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.