Global UDI Compliance
Manage and exchange accurate regulatory data for global compliance and patient safety
Accurate management of product data is critical in healthcare and life sciences because the data associated with these products has a direct impact on human health, patient safety, and the availability of regulated medical devices.
This is why regulatory requirements for Unique Device Identification (UDI) and compliance are so stringent.
In the United States, the Food & Drug Administration (FDA) has set the UDI standards and established a database called the Global Unique Device Identification Database (GUDID). This allows medical device manufacturers to register their products to ensure their compliance with the UDI standards. In the European Union, the European Commission has defined the UDI standard, known as the Medical Device Regulation (MDR), and established a database called EUDAMED. Similar to GUDID, this database allows medical device manufacturers to register their products to ensure their compliance with the standards of MDR UDI.
These regional and country-specific regulations are constantly evolving, and there are rapidly approaching deadlines that must be met long before they take effect. There are an estimated 10-15 regulatory agencies releasing new UDI requirements over the next five years!
Global medical device manufacturers are required to submit UDI data to a variety of country-specific regulators, each with their own standards and data sharing requirements, and it remains difficult to manage and share accurate regulatory data due to:
- Evolving Global Requirements: Harmonizing data across different regions of the world adds cost and effort for medical device providers as the regulatory environment continues to change and the various global standards become significantly more complex.
- Multiple Country Standards: Each country is developing its own standards and guidelines for tracking and monitoring medical devices (EU, UK, China, South Korea, Saudi Arabia, and Australia).
- Single Source of Accurate Data: Clean up all your regulatory data in one centralized solution to ensure validated and up-to-date information for new product launches and give your company a competitive edge.
- Patient Safety: Ensure safe, accurate, and rapid product recalls by fully communicating product registration data to ensure patient safety.
An additional challenge is continuous maintainability when staff and resource changes occur, resulting in loss of business knowledge and skills related to all aspects of UDI.
We understand the complexity of managing and sharing validated regulatory data required to meet ever-changing global regulatory compliance deadlines and the commercial needs of healthcare providers.
Take full control of your compliance processes with Innovit UDI compliance solutions!
Innovit UDI compliance solutions enable medical device manufacturers to implement a single data maintenance and syndication system for global coverage. They use a single solution to aggregate, validate and submit product data at a market-specific level to regulatory authorities worldwide. This enables your company to:
- Simplify the process of managing and sharing validated regulatory data with hospitals, GPOs, and regulators around the world with a global, scalable solution
- Leverage seamless machine-to-machine (M2M) connectivity to meet global compliance requirements from GUDID, EUDAMED, China NMPA and others, while adhering to the stringent US FDA 21 CFR Part 11 and European Union Medical Device Regulation Annex 11, which provide guidance for electronic records and signatures
- Clean and validate your data to ensure patient safety by providing high-quality data
- Work with the leader in global healthcare compliance, regularly working with the EU Commission, US FDA, Australian TGA, Saudi FDA and other regulatory agencies
- Easily share validated product data with lower total cost of ownership
Features & Benefits
Deliver trusted, high-quality product data by leveraging Innovit’s built-in data quality and data validation tools.
Ensure that product data is accurate and compliant with any pre-defined set of validation rules from regulatory agencies, as well as any internal, user-configured data attributes and validation rules.
GAMP 5 Validated
Innovit systems and processes are fully validated to comply with GAMP 5 standards software development, quality assurance, technical support, system implementation.
Built-in functionality for data versioning and electronic signatures to comply with 21 CFR Part 11 requirements (and EU Commission’s Annex 11).
M2M Data Submission
Proven machine-to-machine (M2M) capabilities for regulatory data submissions that ensures data accuracy and a scalable process for data compliance in all markets.
Ease of enabling new countries at a fraction of the cost of alternatives such as data submission services or standalone country-level compliance solutions.
Ready to get started?
Top 12 things to prepare for your global UDI journey
Manufacturers distributing products multi-nationally need to address the rapidly approaching global UDI requirements in play in the U.S. and Europe.
Download our guide to learn the key steps for global UDI compliance.
UDI Solutions, build or buy?
Wondering if you should buy a UDI solution? Why not customize an existing system? Or, just build one?
Read our eBook to learn the pros and cons of each option.