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.
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.