The Ministry of Food and Drug Safety (MFDS) has revised the Regulation on Permission, Notification, Review, Etc. of Medical Devices, with the amendment taking effect on January 26, 2026.

This revision clarifies the legal basis for cybersecurity submissions for devices using wired or wireless communication, expands acceptable clinical evidence in line with global regulatory practices, and improves several administrative procedures identified during operation of the prior system.

The major updates are outlined below according to their regulatory themes.

 

1. Clinical Documentation

Clinical evaluation data has been added as an acceptable submission type.

MFDS accept:

• Clinical trial data from institutions designated by MFDS
• Overseas clinical data recognized as reliable and considered compliant with Korean GCP
• Clinical trial data reviewed for approval in an OECD member country and confirmed or notarized by the relevant authority
• Articles published in SCI or SCIE indexed journals
• Clinical evaluation data (CER)

 

2. Integration of Class II Certification Responsibilities

Certification of Class II devices had been conducted by NIDS, while confirmation of equivalence to already approved or certified products had been handled by MFDS.

Under the amendment, applications seeking confirmation that a device is identical to an already certified Class II product must also be submitted to NIDS, thereby centralizing the authority.

 

3. Innovative Medical Devices

Devices applying entirely new principles of operation or intended uses must obtain approval based on clinical trial data and are subject to post-market surveillance for four to seven years.

In contrast, subsequent applicants may, in certain situations, pursue authorization through equivalence review by referencing a previously approved innovative device without submitting comparable clinical data.

To address this difference in regulatory requirements, the amendment includes innovative medical devices within the priority review framework, enabling priority examination upon application.

In addition, approval or review based on equivalence to Class III and IV innovative devices is restricted while post-market surveillance remains ongoing.

 

4. Scope of Technical Documentation

As documentation requirements vary by product type, the amendment provides clearer examples for certain categories to specify when clinical trial data are required.

 

5. Cybersecurity and Notification Procedures

For devices using wired or wireless communication:

• Cybersecurity information must be included in the Shape and Structure and Precautions for Use sections of the technical documentation.
• Technical documentation requirements now include materials demonstrating the application of cybersecurity measures.

Procedures for acceptance of manufacturing and import notifications have also been clarified.

 

Regulatory Impact

Through this amendment, the scope of acceptable clinical documentation has been expanded, administrative responsibilities have been streamlined, and cybersecurity requirements have been reinforced.

These changes are expected to facilitate the preparation and progress of certification and approval procedures while maintaining regulatory oversight and device safety standards.

Keeping pace with South Korea's evolving medical device regulations is essential for smooth certification and approval. Qualtech supports manufacturers in preparing compliant submissions under the updated MFDS framework.

Contact us to ensure your Korean regulatory strategy remains aligned with the 2026 amendment.

 

Reference

https://www.law.go.kr/행정규칙/의료기기허가ㆍ신고ㆍ심사등에관한규정/(2026-6,20260126)