MFDS - Partial Amendment Notice of Regulations Related to Medical Device Product Renewal and Standard Code System

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Medical Devices


MFDS - Partial Amendment Notice of Regulations Related to Medical Device Product Renewal and Standard Code System


The MFDS (Ministry of Food and Drug Safety) announced that it is amending two regulations related to medical device product renewal and the standard code system to improve and enhance the safety management system for distributed medical devices in a more rational manner.

● Product Renewal: Preparation of Submission Materials Considering the Characteristics of Products Subject to Reporting for Production or Import Discontinuation of Medical Devices and Others. (Effective on October 26, 2023)

● Standard Code: Exemption from the Obligation to Create a New Standard Code Due to Product Name or Model Name Changes. (Effective on October 20, 2023)




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