Overview of market access process for Korea

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Ministry of Food and Drug Safety (MFDS)Previously known as Korea Food and Drug Administration (KFDA), MFDS grants commercial approval (i.e., a license) for medical devices or diagnostics with established safety and efficacy. It is responsible for the implementation of the regulations and standards for medical devices and diagnostics, such as productregistration (based on four classifications, class I through IV), implementing quality systems, post-market surveillance, pre-market clinical study review and approval, etc.National Evidence-based Healthcare Collaborating Agency (NECA)NECA is the HTA organization which assesses through systemic review methodology the safety and effectiveness of new non-pharmaceutical technologies,including associated clinical procedures, prior to HIRA considering reimbursement coverage and pricing (note: economic evaluations are excluded; for pharmaceutical products, HIRA itself undertakes the assessment of pharmacoeconomic evidence submitted by manufacturers). NECA is supervised by MoHW (Ministry of Health and Welfare).Health Insurance Review and Assessment Services (HIRA)HIRA manages reimbursement coverage, coding and pricing of medical devices and diagnostics under the supervision of MoHW (Ministry of Health and Welfare. In addition to these roles, HIRA has various responsibilities including medical claim reviews, appropriate medical service management, pharmaceutical reimbursement application reviews, Drug Utilization Review (DUR), on-site investigations, etc.Collaborating 3rd Party Organization· Medical device testing laboratories: Test labs for medical devices (Testing laboratories designated by the MFDS commissioner)· Medical device quality evaluation institutions: GMP audit & issue certificate with MFDS (Institutes designated by the MFDS commissioner)· Technical document review agency: Review of Technical Document on Class 2 devices (Technical Reviewing agencies designated by the MFDS commissioner)