Amendments to the Regulation on the Permission, Notification, Review, etc. of Medical Devices
The Ministry of Food and Drug Safety (MFDS) amended the Regulation on the Permission, Notification, Review, etc. of Medical Devices on April 28, 2026.
The amendments aim to reduce administrative and financial burdens on manufacturers and importers while improving several aspects of the regulatory framework that required clarification during implementation.
Key Changes under the Regulation on the Permission, Notification, Review, etc. of Medical Devices
1. Expansion of the Grace Period for Products Manufactured or Imported Prior to Change Approval
Previously, manufacturers and importers of Class II, III, and IV medical devices were permitted to continue manufacturing and importing products under the pre-change approval for up to six months after obtaining approval or certification for a change.
However, this provision did not apply to Class I medical devices.
Under the revised regulation, Class I medical devices are now also eligible for the six-month grace period, allowing continued manufacturing and importation of products before the approved change during the transition period.
2. Expanded Acceptance of Real-World Evidence (RWE) as Clinical Data
Previously, real-world evidence could be used in place of clinical trial data only for:
- Orphan medical devices;
- Medical devices requiring emergency introduction;
- 3D-printed medical devices; and
- Medical devices incorporating digital technologies such as big data and artificial intelligence.
The amendment expands the scope of RWE acceptance to include applications involving modifications to existing medical devices, providing greater flexibility in demonstrating clinical safety and performance.
3. Removal of Notarization Requirement for Non-English Documents
Under the previous requirements, foreign-language documents other than English had to be accompanied by a notarized full translation.
MFDS determined that this requirement imposed excessive costs and extended preparation timelines for applicants.
Following the amendment, notarized translations are no longer required. Instead, applicants may submit translations accompanied by a manufacturer-issued confirmation verifying that the translation accurately reflects the original document.
Amendments to the Medical Device Act
The Medical Device Act was amended on December 30, 2025, and is scheduled to take effect on July 1, 2026.
The amendments establish a clearer legal basis for the Medical Device Manufacturing and Quality Management System (QMS) Conformity Recognition Scheme, strengthen regulatory oversight, and promote fair market practices within the medical device industry.
Key objectives include:
- Clarifying legal grounds for conformity recognition of manufacturing and quality management systems;
- Establishing sanctions against fraudulent conformity recognition;
- Strengthening oversight of medical device distribution practices; and
- Improving transparency and order within the medical device market.
Key Changes under the Medical Device Act
1. Introduction of a Four-Year Validity Period for Designated Review Organizations
The designation of technical documentation review bodies and organizations performing conformity recognition-related activities will be valid for four years.
Organizations wishing to continue their activities must apply for renewal before the expiration of the validity period.
2. Restrictions on Transactions with Affiliated Medical Institutions
Medical device distributors and related parties will be prohibited from directly or indirectly selling or leasing medical devices to medical institutions with which they have special relationships.
This measure is intended to promote fair competition and prevent conflicts of interest within the market.
3. Regular Market Practice Surveys
The Minister of Health and Welfare will conduct surveys on medical device distribution practices every three years and publicly disclose the results.
The purpose is to obtain an accurate understanding of market conditions and support policy development.
4. Establishment of the QMS Conformity Recognition Framework
Medical device manufacturers and importers will be required to undergo an assessment of their manufacturing and quality management systems and obtain conformity recognition from MFDS.
Where the assessment results are satisfactory, MFDS will issue a certificate of conformity recognition.
5. Legal Basis for Qualification and Training of QMS Auditors
The amendments establish the legal basis for:
Appointment of QMS auditors;
Training and continuing education programs; and
Delegation of training activities to qualified organizations.
6. Stronger Enforcement Measures
MFDS will be authorized to revoke conformity recognition or amended conformity recognition obtained through false or fraudulent means.
In addition, corrective orders and other necessary measures may be imposed when manufacturers or importers fail to comply with QMS-related requirements.
7. Introduction of Assessment Fees
The amended Act establishes a legal basis for charging fees to applicants seeking conformity recognition through QMS assessments.
Conclusion
MFDS continues to refine the medical device regulatory framework to improve efficiency and strengthen regulatory oversight. Stakeholders should review these amendments and consider their applicability to future registration and compliance activities in Korea.
As South Korea continues to refine its medical device regulatory framework, manufacturers and importers should proactively evaluate the impact of these changes on their registration and compliance strategies. Qualtech team in Seoul office can support your market access and compliance activities in Korea. Contact us now!