Health authorities around the globe, including South Korea's Ministry of Food and Drug Safety (MFDS), have implemented Unique Device Identifier (UDI) database systems for submitting regulatory-mandated medical device product data. The South Korea database is called the Integrated Medical Device Information System (IMDIS).
What is a UDI database?
In 2014, US FDA implemented the first regulatory requirements for UDI. Multiple health authorities around the globe have adopted the concept and created unique regulatory databases. Each medical device product label carries a static device identifier specifying the labeler, model, or version and product identifier that includes the expiration date, serial number, date of manufacture, or the lot/batch number. With UDI, patient safety and product quality issues surface quickly, resulting in improved outcomes for both the device producer and patient.
The South Korean Ministry of Food and Drug Safety (MFDS) rules are mandatory for manufacturers. Compliance timelines are by device classification. UDI compliance became enforced with Article 20 of the Medical Device Act (No. 14330) and Article 54-2 of Enforcement Regulations of Medical Device Act (No. 1512). This regulation activity brought about several UDI compliance requirements:
- Medical device registration and UDI are integrated procedures submitted to the Integrated Medical Device Information System (IMDIS).
- UDI data is reported and applied to labels by class compliance dates.
- A separate Supply Report (Track & Trace) using Form 48-2 (~10 distribution fields) is required each month.
- About 40 Device Identifier (DI) data attributes (15 are similar to US FDA) are required.
- The label UDI includes DI and conditional Production Identifier (PI).
- Direct Marking is required on certain products (multi-use, reprocessed and any products separated from original packaging before use.)
- A local representative (South Korea License Holder) must be appointed to create the IMDIS account and report UDI information. The local representative carries other regulatory responsibilities on behalf of the manufacturer.
Registration and UDI submission options are available on the IMDIS website. The XLS file template may be downloaded for completion and uploaded. Users may utilize manual direct entry to the interface. Or for large datasets, engage with a trusted UDI provider for machine-to-machine API transfer. The IMDIS is production only. No testing or pre-production site is available.
How to Prepare for IMDIS UDI and Registration
Preparing for UDI compliance for almost any health authority requires some basic implementation processes. Creating the UDI environment to assign role responsibilities both for corporate office members and in-country representative is essential. Guidance and technical documents will need translation, approvals and finalization. Next, understanding all the data attributes that need to be collected and where the data resides will require establishing workflows.
Cleansing data and centralizing the source will create efficiencies. A communication process for scenario-based product changes and response to downstream events (when they occur) is needed. A baseline view into the UDI product data for both corporate and in-country representatives will streamline communication.
Lastly, to comply with regulations, an account is set up in the South Korea IMDIS database, registering the medical device with MFDS (via a Korea In-Country Caretaker or Representative) and populating all required fields. UDI data is submitted and acknowledged between the account holder and IMDIS.
Many companies are already marketing medical devices in multiple global regions and preparing for upcoming mandates for South Korea IMDIS, China NMPA, European Union EUDAMED and other emerging regulators. The task of compliance for UDI product data requires a solid workflow plan and gaining knowledge of complex requirements for perhaps multiple health authorities. A shared view of UDI data for all the product markets in your portfolio is a superior strategy over point solutions for each region.
To learn more about UDI in South Korea, see additional resources concerning IMDIS registration and UDI data attributes to share with your team.