Labeling errors can potentially result in lawsuits or product recalls, which can be extremely costly in terms of labor and time
Fremont, CA: In the medical industry, Unique Device Identification (UDI) represents the process of identifying any product that is not pharmaceutical in nature. UDI system is essential to keep track of the devices in the supply chain. The United States Food and Drug Administration (FDA), and other regulators have made patient safety a priority by developing legislation for UDI, in which case manufacturers also need to accept the regulations on medical devices.
Though these standards are important to ensure patients' safety and boost efficiency in the processes for all stakeholders worldwide, it can create regulatory challenges for manufacturers.
Let us discuss the challenges in managing regulatory labeling:
Many senior medical supply chain executives claim that regulatory compliance is among the industry's biggest challenges. And, when the regulation involves identifying products correctly, labeling has become the focal point. Device manufacturers are facing several challenges in reducing expenditure in the supply chain, maintaining quality, and decreasing labeling errors. Labeling errors can potentially result in lawsuits or product recalls, which can be extremely costly in terms of labor and time.
As medical device and pharmaceutical organizations seek to utilize existing products in new markets or extend product ranges in existing geographies, ensuring that packaging is accessible to the people of a particular market has become important. Therefore, it is mandatory for manufacturers to carefully control the medical devices' labels at a global level for the sake of patient safety. Labels must be accurately and safely customized in accordance with local languages and country-specific requirements.
Label update is a time-taking process in which every single edit/update in the template needs to follow a workflow and approval process before it is approved for production printing.
The persistent demand to focus resources on medical device regulation has led to reprioritizing and/or delaying other project initiatives, thereby forcing manufacturers to hire, retrain, or rely on outsourcing work. It increases departmental costs.