Are you truly ready to meet UDI requirements?
Medical devices are crucial life savers. Governments have imposed regulations to secure the supply chain. Systech pioneered pharmaceutical serialization and we know how to meet the requirements.
Medical devices consist of articles, instruments, apparatuses or machines that are used in the prevention, diagnosis or treatment of illness or disease. They can also be employed for detecting, measuring, restoring, correcting or modifying the structure or function of the body for some health purpose. In other words, medical devices are integral to the care and treatment of people—a life and death proposition. Manufacturers know this and governments are acutely aware of the importance of medical device authenticity that they are implementing regulations to protect the supply chain.
The global medical device market is over $400 billion in annual sales. High-profit markets are not ignored by counterfeiters and gray market players. Counterfeiting and diversion are realities for all medical device manufacturers. The World Health Organization (WHO) has stated that one in ten medical products in developing countries are counterfeit. The pervasiveness of the internet and e-storefronts has made it easier than ever for supply chain criminals to create an open market for illicit medical devices. Given that one fake valve or implant being used on a patient is one too many, the medical device supply chain must be as secure and controlled as possible.
Many geographies (US and EU included) have introduced serialization regulations to safeguard the pharmaceutical supply chain. As you are most likely aware, they have introduced similar Unique Device Identifier (UDI) regulations for medical devices. Systech was the first vendor to launch a productized serialization solution for pharma and that same proven platform can be used to secure medical devices with UDIs. Trusted by the world’s leading pharmaceutical companies, this platform runs more serialized lines than any other vendor.
Most UDI requirements involve putting an identifying barcode on a package, but some also have traceability mandates. The Systech Brand Protection Suite™ brings together the key pillars of compliance and safety—serialization, traceability, authentication and insight—for complete item transfer visibility and seamless, secure data exchange throughout the supply chain. So, with one platform, you can meet UDI requirements, secure your supply chain, and do much more than put a barcode on a package.
Learn more about the US FDA definition of medical devices, medical device class specifications and UDI requirement compliance dates.