Korea Amends Medical Device Regulations: MFDS Updates Classification & Grouping
Country: Korea, Republic of
Notification Date: 2026-01-29
The Republic of Korea's Ministry of Food and Drug Safety (MFDS) proposes significant amendments to its "Regulation on Medical Device Group and Class by Group." This WTO TBT notification signals key changes aimed at enhancing medical device safety management efficiency through clearer classification and addressing existing regulatory issues. Businesses exporting medical devices to Korea should pay close attention to these updates.
Key Details- Country: Korea, Republic of
- Document Symbol: G/TBT/N/KOR/1339
- Notification Date: 2026-01-29
- Comment Deadline: 2025-12-05 (for domestic consultation of the draft)
- Effective Date: To be determined
The proposed amendments cover three main areas:
- Establishment of New Items: Five new medical device items are being established to properly classify temporarily designated items. Examples include 'Myopia control lens' (Class 2), 'Vertebral body replacement implant' (Class 3), 'Fixative system for laminoplasty and laminectomy' (Class 3), 'Surgical Gown' (Class 2), and 'Sustained Release Drug Delivery' (Class 4).
- Adjustment of Medical Device Class: One item, 'Impression pre-treatment material' (C26020.01), is reclassified from Class 2 to Class 1. This adjustment considers international harmonization and equity with other medical devices.
- Modification of Item Definition: The definitions of five medical device items are being modified, including corrections of clerical errors. This includes spelling corrections for terms like 'Pritoneal' to 'peritoneal' and 'seperating' to 'separating,' as well as refining the definition of 'Absorbable nerve cuff' and 'Adhesion barrier dressing.'
- Affected Products/Sectors: Manufacturers and exporters of medical devices, particularly those involved in ophthalmology, orthopedics, surgical supplies, drug delivery systems, and dental materials, will be directly impacted.
- Potential Impact on International Trade: These changes may necessitate re-evaluation of existing product classifications and potentially new registrations or certifications for certain devices entering the Korean market. Clarity in classification can streamline processes but also requires proactive compliance.
- Compliance Requirements for Exporters: Exporters must align their product classifications, labeling, and documentation with the updated regulation. New product items will require formal classification and approval pathways under the revised framework.
- Market Access Implications: The establishment of new classifications aims to provide clearer regulatory paths, while reclassification (e.g., to a lower class) could simplify market entry for specific products. However, failure to comply with new classifications or definitions could lead to market access delays or restrictions.
- Recommended Actions: Companies should thoroughly review the full amended regulation once it is officially published. Verify if any of your medical devices fall under the newly established items, reclassified items, or have modified definitions.
- Compliance Timeline: While many changes are expected to take effect upon official announcement, there are special provisions. For instance, manufacturers/importers of surgical gowns (B07010.03) may continue under previous regulations for up to three years from the effective date, while also being able to obtain approval under the new rules.
- Resources/Contacts: For further details and guidance, businesses should consult the Ministry of Food and Drug Safety (MFDS) of Korea or relevant trade associations.
The Republic of Korea's MFDS is actively updating its medical device regulations to enhance safety and streamline management. These amendments, covering new item establishment, reclassification, and definition modifications, are crucial for international trade compliance. Proactive engagement and a thorough review of these changes are essential for all medical device companies exporting to Korea to ensure continued market access and avoid regulatory hurdles.
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