1. Background

Following amendments to the Medical Devices Act (Act No. 21263, December 30, 2025), a legal basis was established for KGMP conformity assessments and the management of auditors responsible for evaluating medical device manufacturing and quality management systems.

In response, the MFDS reorganized the existing Standards for Medical Device Manufacturing and Quality Management by transferring provisions concerning the designation and management of assessment bodies and training organizations to a separate regulation.

Separately, the MFDS revised medical device adverse event reporting requirements to clarify the scope of reportable events and establish reporting timelines based on potential risks to patients.

2. Revision to the Regulation on the Management of Medical Device Safety Information, Including Adverse Events

Revision and Effective Date: September 22, 2026

The MFDS revised the Regulation on the Management of Medical Device Safety Information, Including Adverse Events to clarify the scope of reportable adverse events and adjust reporting timelines for product issues presenting a relatively low risk of harm to patients.

2.1 Clarification of Reportable Events and Reporting Timelines

The revised Article 5(1)(3) specifies the reporting timeline for medical device product issues, such as defects or malfunctions, that did not cause any health-related or clinical impact on patients at the time of occurrence but could potentially result in adverse effects.

Under the revised provision, such product issues must be reported within one month after the end of the relevant calendar quarter.

Other adverse reportable events remain subject to their applicable reporting timelines, depending on the nature and severity of the event.

This amendment introduces a more risk-based reporting approach by distinguishing reporting timelines according to the nature and potential impact of medical device incidents.

2.2 Regulatory Implications

Medical device manufacturers and importers should distinguish between incidents involving actual health-related or clinical impacts on patients and product issues that present only a potential risk of harm when determining the applicable reporting requirements.

The revised quarterly reporting timeline applies only to the specific category of product issues defined under Article 5(1)(3). Manufacturers and importers should review their adverse event reporting procedures to ensure that incidents are appropriately classified and reported within the applicable timelines.

3. Revision to the Standards for Medical Device Manufacturing and Quality Management (KGMP)

Revision and Effective Date: July 1, 2026

Following amendments to the Medical Devices Act, the MFDS revised the Standards for Medical Device Manufacturing and Quality Management to improve the clarity and usability of regulations governing KGMP conformity assessments.

3.1 Separation of KGMP Assessment Requirements

Previously, the regulation covered both KGMP conformity assessments and administrative requirements concerning the designation and management of quality management assessment bodies and training organizations for quality managers.

Under the revised framework, provisions concerning the designation and management of these organizations have been transferred to the newly established Regulation on the Designation of Organizations Related to Medical Device Manufacturing and Quality Management.

As a result, the revised KGMP regulation now focuses primarily on requirements related to KGMP conformity assessments, providing a clearer regulatory framework for manufacturers and importers.

3.2 Regulatory Implications

The revision primarily reorganizes the regulatory framework rather than introducing substantial changes to KGMP conformity assessment requirements.

For medical device manufacturers and importers, the revised KGMP standards continue to serve as the regulatory basis for KGMP conformity assessments. Manufacturers and importers should ensure that their regulatory documentation and references are aligned with the updated provisions.

4. Establishment of the Regulation on the Designation of Organizations Related to Medical Device Manufacturing and Quality Management

Establishment and Effective Date: July 1, 2026

Following amendments to the Medical Devices Act, the MFDS introduced the Regulation on the Designation of Organizations Related to Medical Device Manufacturing and Quality Management.

The new regulation consolidates provisions previously included in the KGMP standards concerning the designation and management of assessment bodies and training organizations. It also establishes detailed requirements for the qualification, appointment, and training of auditors responsible for assessing medical device manufacturing and quality management systems.

The key provisions are summarized below.

4.1 Designation and Management of Quality Management Assessment Bodies

Articles 5–14

These provisions establish procedures and requirements for the designation and management of quality management assessment bodies, including their responsibilities and compliance obligations.

The relevant provisions were transferred from the previous Standards for Medical Device Manufacturing and Quality Management.

4.2 Qualification, Appointment, and Training of Auditors

Articles 15–19

These provisions specify qualification requirements, appointment and revocation procedures, and training requirements for auditors responsible for evaluating medical device manufacturing and quality management systems.

They provide detailed requirements for implementing the auditor management framework established under the amended Medical Devices Act.

4.3 Designation and Management of Auditor Training Organizations

Articles 20–22

These provisions establish detailed procedures for the designation of auditor training organizations, including training content, methods, and compliance obligations.

4.4 Designation and Management of Training Organizations for Quality Managers

Articles 23–26

These provisions specify the procedures for designating and managing organizations responsible for providing training to medical device quality managers.

The relevant requirements were transferred from the existing KGMP regulation to the newly established regulation.

5. Key Effective Dates

Regulation	Regulatory Action	Effective Date
Regulation on the Management of Medical Device Safety Information, Including Adverse Events 의료기기 부작용 등 안전성 정보 관리에 관한 규정	Revised September 22, 2026	September 22, 2026
Standards for Medical Device Manufacturing and Quality Management 의료기기 제조 및 품질관리 기준	Revised July 1, 2026	July 1, 2026
Regulation on the Designation of Organizations Related to Medical Device Manufacturing and Quality Management 의료기기 제조 및 품질관리 관련 기관 지정 등에 관한 규정	Established July 1, 2026	July 1, 2026

6. Conclusion

The recent MFDS regulatory updates primarily focus on revising medical device adverse event reporting timelines and restructuring the KGMP regulatory framework.

The amendment to the regulation on medical device safety information introduces a quarterly reporting timeline for certain product issues that did not cause actual health-related or clinical impacts on patients but may present potential risks.

Meanwhile, the revision to the KGMP standards and the establishment of a separate regulation for relevant organizations clarify the distinction between KGMP conformity assessment requirements and the management of assessment bodies, auditors, and training organizations.

These regulatory updates took effect on September 22, 2026, and July 1, 2026, respectively.

Stay Compliant with South Korean Latest MFDS Regulations

Navigating the updated adverse event reporting requirements and KGMP framework? With our local office in Seoul, Qualtech provides on-the-ground regulatory support to ensure compliance with MFDS requirements and facilitate medical device market access in South Korea.

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