[MDREX NEWSLETTER] Announcement of MFDS Guidelines Following Announcement of MFDS Guidelines Following the Implementation of the Digital Medical Products Act |
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With the implementation of the Digital Medical Products Act on January 24, 2025, the Ministry of Food and Drug Safety (hereinafter “MFDS”) has published and distributed the “Guidelines on Administrative Procedures Following the Enforcement of the Digital Medical Products Act.” These guidelines include details regarding products subject to the Digital Medical Products Act, methods for categorization and classification of products, procedures to acquire relevant business license and product approval/certification/notification, criteria for exemption from clinical trial plan approval, KGMP certification procedures, methods to secure against electronic infringements, certification of excellent quality management systems, labeling requirements, details regarding management, supervision, and penalties, etc. Additionally, it provides brief responses to frequently asked questions in the Q&A section.
Please find below excerpts from the Q&A section that may be of your interest regarding the application of the Digital Medical Products Act.
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Q. Has the scope of digital medical/health support devices been defined?
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A. The detailed scope of digital medical/health support devices is currently under review and will be finalized with consideration of the relevant section’s enforcement date.
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Q. Should medical device manufacturers/importers who already hold approvals for products transitioning to digital medical devices separately apply for manufacturing/import licenses for digital medical devices?
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A. Existing medical device manufacturing or import business licenses will remain valid, and a separate application must be submitted to obtain a manufacturing/import business license for digital medical devices.
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Q. When conducting data-based clinical trials, must companies comply with procedures under separate laws in addition to MFDS and IRB reviews?
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A. When conducting data-based clinical trials, procedures under the Personal Information Protection Act and the Medical Service Act, in addition to the Digital Medical Products Act, must be followed.
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Q. If a company manufactures/imports both medical devices and digital medical devices, can GMP audits for both be conducted simultaneously?
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A. A combined GMP audit for medical devices and digital medical devices is not possible.
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Q. If a manufacturer of medical devices with AI/ML functions already holds a medical device GMP certification, is a separate GMP certification for digital medical devices required?
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A. If one holds a valid medical device GMP certification, it will remain valid until its expiration; however, the next periodical renewal review will have to be conducted based on the GMP standards for digital medical devices.
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Q. What should companies prepare when applying for a remote site inspection of software manufacturing facilities?
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A. Due to security concerns, such as the leakage of confidential documents during GMP audits, etc., companies must prepare programs or systems that enable secure remote site inspections.
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