The South Korean Ministry for Food and Drug Safety (MFDS) has established new regulations for registration of IVD products in order to improve oversight of these devices’ safety and quality, according to the agency.

The new MFDS requirements, known as the In-vitro Diagnostic Medical Devices Act (link in Korean), goes into effect in May 2020. MFDS has now devised IVD regulations distinct from its Medical Devices Act of 2017, in which market authorization requirements for IVDs had previously been included. As healthcare models in markets including South Korea move toward greater emphasis on prevention and early diagnosis of diseases and conditions, more targeted requirements for IVD devices was necessary, according to MFDS.

Overview of the new IVD regulation

According to Emergo by UL consultants in Seoul, the In-vitro Diagnostic Medical Devices Act remains a high-level regulation, with no specific application methods or requirements yet developed.

So far, MFDS has provided the following information regarding the new regulation:

• IVD product definitions, in keeping with how other regulators define these devices;
• Registration requirements for IVDs that comprise pharmaceutical and medical device components;
• Procedures for conducting clinical performance tests for IVD devices, including importation requirements for IVDs undergoing clinical performance tests in South Korea;
• Certification requirements from MFDS for hospitals or laboratories conducting IVD testing;
• Labeling requirements for IVDs.

Emergo by UL sources in South Korea will provide updates and additional details on the new IVD regulations as we learn them.

Related South Korean IVD and medical device regulatory resources:

• South Korea MFDS medical device registration consulting
• South Korea KGMP quality management system compliance support
• Regulatory process chart: South Korea MFDS medical device approval requirements