Complying with UDI regulations from various regulatory bodies is a complex task. With the UDI Platform, you keep control of your UDI data at all times.
With our cloud-based UDI Platform, you can manage the data of your medical devices centrally in one place and exchange it directly with the regulatory authorities – flexible, simple, and compliant.
The UDI Platform is tailored to your needs and internal processes. It allows you to easily prepare data, quickly validate, and easily transfer your UDI data to the authorities. With the UDI Platform you always keep track of your data.
Stay on top of markets and UDI regulations. We make ensuring your UDI compliance easy. We constantly analyze the requirements of relevant markets and promptly implement changes. This ensures that your data is always up-to-date.
The UDI Platform can be seamlessly integrated into your existing system landscape, allowing you to incorporate existing data. A close integration with the authorities’ systems enables you to directly exchange data both, from and into the UDI Platform and your internal systems.
Dr. Antje Giffing, Head of Regulatory Affairs, Raumedic AG
Sebastian Deeg, Head of Information Technology, Raumedic AG
USA | FDA (GUDID) | AVAILABLE
✓ GUDID Data Model with all required attributes
✓ All validation and changeability rules
✓ Grace period handling
✓ Unlocking functionality for critical corrections
✓ M2M Data submission to GUDID database
COLOMBIA I INVIMA (ESTÁNDAR SEMÁNTICO) I AVAILABLE
✓ Estándar semántico Data Model with all required attributes
✓ All validation and changeability rules
✓ Data submission via Estándar semántico Excel template
EUROPE I EC (EUDAMED) I AVAILABLE
✓ Eudamed Data Model with all required attributes
✓ All validation and changeability rules
✓ M2M Data submission to Eudamed database
SAUDI ARABIA I SFDA (SAUDI-DI) I AVAILABLE
✓ Saudi-DI Data Model with all necessary attributes
✓ All validation and changeability rules
✓ Data submission via Saudi-DI Excel template
CHINA | NMPA (CUDID) | AVAILABLE
✓ CUDID Data Model with all required attributes
✓ All validation and changeability rules
✓ M2M Data submission to CUDID database
AUSTRALIA I TGA (AUSUDID) I AVAILABLE
✓ AusUDID Data Model with all required attributes
✓ All validation and changeability rules
✓ Grace period handling
✓ Correction functionality for critical corrections and updates
✓ M2M Data submission to AusUDID database
TAIWAN I TFDA (TUDID) I AVAILABLE
✓ TUDID Data Model with all necessary attributes
✓ All validation and changeability rules
✓ Data submission via TUDID Excel template
SOUTH KOREA | MFDS (IMDIS) | AVAILABLE
✓ IMDIS Data Model with all required attributes
✓ All validation and changeability rules
✓ M2M Data submission to IMDIS database
JAPAN I MEDIS-DC (KIKIDB) I AVAILABLE
✓ Compliance with KIKI DB is only voluntary!
✓ KIKI DB Data Model
✓ Data transfer supported with KIKI DB Excel template
BRAZIL I BRAZIL (SIUD) I UNDER DEVELOPMENT
✓ SIUD Data Model with all required attributes
✓ All validation and changeability rules
✓ Grace period handling
✓ Unlocking functionality for critical corrections
✓ M2M Data submission to SIUD database
SWITZERLAND I SWISSMEDIC (SWISSDAMED) I UNDER DEVELOPMENT
✓ Swissdamed Data Model with all required attributes
✓ All validation and changeability rules
✓ M2M Data submission to swissdamed database
(incl. Lichtenstein)
SINGAPORE | HSA (SMDR) | UNDER DEVELOPMENT
✓ SMDR Data Model with all necessary attributes
✓ All validation and changeability rules
✓ Data submission via SMDR Excel template
Active monitoring and rapid implementation of new UDI requirements
Reuse existing data for new markets
Configuration and automation of processes for faster UDI compliance
Global and scalable concept for upcoming UDI regulations
Experienced team of experts for global UDI compliance
Learn how to stay GxP-compliant in the cloud.
