What to Know for Medical Device UDI Compliance in South Korea


South Korea Ministry of Food and Drug Safety (MFDS) began UDI activity in 2018 with the MFDS notification No. 2020-29. UDI compliance is mandatory and was implemented by Article 20 of Medical Device Act (No. 14330) and Article 54-2 of Enforcement Regulations of Medical Device Act (No. 1512). Registration in the Integrated Medical Device Information System (IMDIS) is required in order to market a medical device in South Korea. The next mandate for UDI reported and on-label compliance is due 2021 September for Class II. Track and Trace requirements are due 2021 July for Class III.

Screen Shot 2021-06-02 at 3.44.37 PMWith this regulation activity, several key compliance steps must occur. Is your regulatory team prepared for compliance activity and UDI data submissions?

Download a quick reference guide to South Korea IMDIS Registration to learn more.




Multi-Channel Health Authority UDI System Provider

Reed Tech is currently providing machine-to-machine UDI submissions to South Korea IMDIS (UDI database). To meet upcoming mandates, Reed Tech is prepared to store data, establish a connection, and electronically transfer UDI data to South Korea and other regional UDI databases. This arrangement creates a global approach for maintaining UDI product information and allows in-country representatives in China, South Korea, EU, or any region to use the Reed Tech SingleSource™ for Medical Devices platform for UDI data management and submission.

Regulatory compliance teams will benefit from experienced help with the nuances of UDI requirements and product data management. The subject-matter experts at Reed Tech can help:

•   Leverage expertise to current IMDIS machine-to machine submissions in production
•   Utilize know-how gained from experience with US FDA and other health authorities around the globe
•   Centralize product data in a single data hub for all the Health Authorities in your product markets
•   Integrate in-country users (subsidiary or affiliate, agent or distributor) for a team view
•   Gain auditing and versioning peace of mind for maintaining UDI data
•   Share product data internally or externally with downstream customers

Contact Reed Tech for solutions and services for medical device UDI requirements for South Korea MFDS and other global health authorities.

Download a quick reference guide to South Korea IMDIS Registration