Primer on South Korea’s Medical Device Regulatory System

By Sora Lee, JaeYeong Noh, Dayeon Choi, and Evangeline Loh

As the Korea International Medical & Hospital Equipment Show (March 14-17, 2024, KIMES) has concluded, we share a primer on South Korean medical device regulations in this article series.

The medical device regulatory system in South Korea

The Ministry of Food and Drug Safety (MFDS) is the medical device regulator in South Korea. The medical device regulatory system is designed to be analogous to other global regulatory systems.

Devices need to be classified based on the degree of risk posed to the patient by using the device. It is the risk classification as well as the existence of predicate devices that determines the regulatory route/submission to be filed. In addition, manufacturers of higher-risk medical devices must be compliant with the quality management system and possess a certificate compliant with the Administrative Rules of the Medical Device Act, Good Manufacturing Practices, K-GMP.

Similar to the Japan MHLW/PMDA regulator, the South Korean regulatory system also uses a mix of reviews by third-party auditors (TPA), third-party reviewers (TPR) and the MFDS, based on the risk classification of the devices. One difference with Japan is that the lowest-risk devices in South Korea only need to be registered with the National Institute of Medical Device Safety Information (NIDS).

Risk classification system in South Korea

The classification rules and procedures are outlined in South Korea’s medical device legislation. The system is similar to that of the U.S. FDA in that each device type is assigned an explicit classification, Class 1-4.

The Table below describes the risk classification of devices in South Korea.

The MFDS risk-based classification of medical devices

*The class may vary depending on the exact intended use of the medical device.

Regulatory routes/marketing authorizations

There are three regulatory routes modestly aligned with the Japanese PMDA/MHLW. Class I devices require a Pre-market Notification. Manufacturers of Class 2 devices with a predicate device must file a Pre-market Certification. Novel Class 2 devices without a predicate device and Class 3 and 4 devices require a Pre-market Approval.

Pre-market Notifications are only reported to the NIDS. The Technical Documentation for a Pre-market Certification is reviewed by a TPR unless the Class 2 device is exempted as a Recognized Substantial Equivalent device, in which case the TPR will only review to confirm the device is indeed a Recognized Substantial Equivalent.

The Technical Documentation for Class 3 and 4 devices subject to Pre-market Approval are reviewed by the MFDS

K-GMP Certificates

Only manufacturers of Class 2, 3, and 4 devices are required to obtain a K-GMP certificate.

The MFDS is engaged in international activities

The MFDS is a member of the International Medical Device Regulator Forum (IMDRF). In addition, the MFDS is an Affiliate Member of the Medical Device Single Audit Program (MDSAP). There have been developments with the MFDS and use of MDSAP certificates which will be reported on in one of our subsequent regulatory updates.

Concluding remarks

The regulatory system in South Korea is complicated. For more information about the process of registering devices with the MFDS, please review our webinar.

Engaging a reputable partner is an important aspect of navigating the regulatory system. Emergo by UL  provides consulting services in South Korea and provides services as the Korean License Holder to manufacturers who are not based in South Korea.