South Korea Updates Medical Devices Oversight Framework

South Korea has proposed comprehensive amendments to strengthen regulatory oversight of medical devices through updated enforcement and classification rules

Compliance Analysis: Proposed Amendments to South Korea’s Medical Device Regulations

The Republic of Korea’s Ministry of Food and Drug Safety (MFDS) has proposed four key regulatory amendments to strengthen oversight of medical devices. These amendments update the Enforcement Rule of the Medical Devices Act, the Regulation on the Permission, Notification, Review, etc of Medical Devices, the Regulation on Medical Device Group and Class by Group, and the Regulations on the Classification Categories of Digital Medical Products. The changes aim to enhance post-market surveillance exemptions for orphan devices, clinical evidence standards, classification harmonization, and digital health product definitions, while streamlining administrative procedures.

1. Key Amendments Overview

Below is a structured summary of the proposed changes, organized by regulation and core requirement:

2. Detailed Breakdown by Regulation

2.1 Enforcement Rule of the Medical Devices Act¹

• GMP Conformity Assessment: The amendments introduce detailed procedures for Good Manufacturing Practice (GMP) conformity assessments, delegating authority to designated bodies¹.
• Technical Documentation Review Institutions: Establishes criteria and renewal processes for institutions authorized to review technical documentation, ensuring consistency in evaluations¹.
• Orphan Device Exemptions: Expands post-market surveillance exemptions for orphan medical devices (devices for rare conditions), reducing regulatory burden while maintaining safety oversight¹.

2.2 Regulation on the Permission, Notification, Review, etc of Medical Devices²

• Grace Period for Class 1 Devices: Manufacturers/importers of Class 1 devices (lowest risk) may continue production/importation for 6 months post-approval changes without re-notification, provided no safety risks are identified².
• Real-World Evidence (RWE): Broadens the acceptable scope of RWE (e.g., observational studies, registries) as valid clinical investigation documents, aligning with global trends².
• Document Translation: Eliminates notarization requirements for translations of foreign-language documents (excluding English), simplifying administrative processes².

2.3 Regulation on Medical Device Group and Class by Group³

• New Items: Adds five new medical device items to the classification system, addressing previously unclassified or temporarily designated devices³.
• Reclassification: Adjusts the risk class of one item to align with international standards (e.g., IMDRF, EU MDR) and ensure equity with similar devices³.
• Definition Updates: Modifies definitions for five items, including corrections of clerical errors, to improve clarity and regulatory precision³.

2.4 Regulations on the Classification Categories of Digital Medical Products⁴

• Scope Designation: Formally defines the boundaries of digital medical products and health support devices, distinguishing between regulated medical devices and non-regulated health tools (e.g., wellness apps)⁴. This amendment took effect on 24 January 2026⁴.

3. Stakeholder Implications

• Manufacturers/Importers:
  • Class 1 devices benefit from the 6-month grace period for post-approval changes².
  • Orphan device manufacturers gain reduced post-market surveillance obligations¹.
  • Digital health developers must reassess product classification under the new scope definitions⁴.
• Review Institutions: Must comply with new designation/renewal procedures for technical documentation reviews¹.
• Clinical Investigators: May leverage expanded RWE for clinical data submissions².

4. Comment Periods and Compliance Timelines

Note: Stakeholders may submit comments to the Korea WTO TBT Enquiry Point (¹(mailto:tbt@korea.kr)) before the respective deadlines^{1, 2, 3}.

Summary Answer

South Korea’s proposed amendments to its medical device regulations introduce four key updates to enhance oversight and reduce administrative burdens:

1. GMP conformity assessments, technical review institution procedures, and post-market surveillance exemptions for orphan devices under the Enforcement Rule of the Medical Devices Act¹.
2. 6-month grace periods for Class 1 devices, expanded RWE use, and abolished notarization requirements in the Regulation on the Permission, Notification, Review, etc of Medical Devices².
3. New device classifications, reclassification of one item, and definition updates in the Regulation on Medical Device Group and Class by Group³.
4. Formal scope designation for digital medical products, effective 24 January 2026⁴.

These changes aim to harmonize with international standards, streamline approval processes, and clarify regulatory boundaries for emerging technologies. Stakeholders should review the proposed rules and submit comments by the respective deadlines^{1, 2, 3, 4}.

Sources

1. ↩ Proposed amendments to the “Enforcement Rule of the Medical Devices Act” https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=Q:/G/TBTN26/KOR1349.pdf&Open=True
2. ↩ Proposed amendments to the “Regulation on the Permission, Notification, Review, etc of Medical Devices” https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=Q:/G/TBTN26/KOR1348.pdf&Open=True
3. ↩ Proposed amendments to the “Regulation on Medical Device Group and Class by Group” https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=Q:/G/TBTN26/KOR1339.pdf&Open=True
4. ↩ Proposed amendment to the “Regulations on the Classification Categories of Digital Medical Products” https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=Q:/G/TBTN25/KOR1321.pdf&Open=True