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Product Licensing
Product Licensing
Service Progress Procedure

Medical Device Classification

Grade-by-Grade Procedures [Summary]
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Grade 1: If you register and apply online at the 'Medical Device Electronic Civil Complaint Window', the 'Korea Medical Device Safety Information Institute' will process the report and issue a report certificate.
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Grade 2: After the 'Medical Device Technical Document Review' is completed and a Notice of Conformity is issued, you can receive a certificate from the 'Korea Medical Device Safety Information Institute'.
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Grade 3/4: If clinical trial data is not required, a 'medical device technical documentation review' is conducted. If clinical trial data is required, a 'clinical data review' is conducted. If it is deemed appropriate, a license can be issued by the 'National Institute of Food and Drug Safety Evaluation'.







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