Serialization And Traceability Compliance In Pharma And Med Device: What Should You Know?

By John Carlin

The lack of standardized medical device identification between product manufacturers, distributors, and healthcare institutions makes it difficult to quickly find and identify devices, which leads to increased medical errors, product counterfeiting, and diversion. To prioritize patient safety and the transparency of the global supply chain, China’s National Medical Product Administration (NMPA), the EU Commission, US Food and Drug Administration, and regulators in other countries have introduced Unique Device Identification (UDI). However, to make the transition to the new system possible, medical device manufacturers and labelers must overcome considerable implementation challenges.

Since economies and supply chains are highly interconnected and interdependent, compliance in today’s globalized economy poses a myriad of questions and requires manufacturers to maintain a global perspective and avoid getting lost in details. Learn how to achieve compliance with medical device regulations worldwide and stay compliant long-term in spite of the ever- changing requirements. Additionally, explore the role of traceability and serialization and the business benefits they offer beyond compliance along with a global perspective on how to approach UDI implementation and choose an appropriate solution.