[MDREX NEWSLETTER] MFDS Pre-announces Enforcement Rule
Korean MFDS Pre-announces Enforcement Rule for the Management of Digital Medical/Health Support Devices (Effective January 1, 2026)
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On August 6, 2025, the Ministry of Food and Drug Safety (MFDS) of Korea announced an administrative notice of the amendment to the Enforcement Rule of the Digital Medical Products Act, which stipulates the procedures for manufacturing/import notification, performance certification, and distribution management of digital medical/health support devices (hereinafter referred to as "wellness products"). This proposed revision aims to strengthen procedures related to notification, performance certification, and post-market surveillance of wellness products.
The amendment is scheduled to take effect on January 1, 2026. Key highlights are as follows:
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1. Specific Procedures for Manufacturing or Import Notification of Wellness Products
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Manufacturers or importers of wellness products may submit a prior notification of the products to the MFDS using a newly established form. (Article 47(1) revised)
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Any changes or performance certifications acquired concerning the notified product must also be separately reported to MFDS. (Article 47(3) newly added)
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2. Application and Procedures for Performance Certification of Wellness Products
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- Manufacture's Development Standards Document:
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Procedures and methods for Performance testing (accuracy, reproducibility, etc.)
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In the case of products that provide health information, objective evidence thereof
- Internal test reports according to the manufacturer's development standards
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Product description
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Performance testing report (If performance certification already obtained)
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The certification body shall conduct performance tests based on the submitted materials and the results shall be notified to the applicant and uploaded to the MFDS information system. (Article 47-2(2), (3))
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If any changes to certified performance are required, change certification applications must be submitted. (Article 47-2(4))
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3. Administrative Measures, such as Sales Suspension, Recall, etc.
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If a wellness product in distribution is found to have misleading or exaggerated claims, the MFDS may order the manufacturer, importer or distributor for recall, exchange, disposal, or suspension of sales, and such order shall be publicly disclosed on the MFDS website. (Article 47-5(1) newly added)
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The manufacturer, importer or distributor must implement the measure and report the results to the MFDS within 30 days. (Article 47-5(2), (3))
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Failure to comply may lead to:
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Administrative penalties under Article 58 of the Digital Medical Products Act (fine up to KRW 5 million)
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Referral to the Fair Trade Commission for additional sanctions under the Act on Fair Labeling and Advertising, including fines (up to 2% of sales or KRW 500 million), and criminal liability
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Although notification and performance certification applied to wellness products may seem like voluntary options, because they can be considered as procedures that are essential for manufacturers and importers to reduce regulatory risk during sales and marketing activities, and the presence (or absence) of such certification can be used as the basis for administrative measures in the post-market surveillance, they could very well be considered as matters that must be observed in practice.
Therefore, manufacturers and importers of wellness devices need to carefully review this regulatory amendment and establish a proactive compliance strategy in preparation for its enforcement.
If you have any questions or require tailored consulting, feel free to reach out.
Thank you.
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C 922, 7, Beobwon-ro 11-gil, Songpa-gu, Seoul, Korea
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