STANDARDS FOR AUTHENTICATION AND TRACEABILITY OF HEALTH PRODUCTS AND TECHNOLOGIES

The healthcare landscape is constantly evolving, demanding robust systems to ensure patient safety and product integrity. In this ever-changing environment, Authentication and Traceability (A&T) for medical products has become paramount. A&T safeguards patients from falsified or substandard Health products and Technology (HPT), protects public health, and fosters trust within the healthcare supply chain.

Due to the expansion and worldwide integration of commerce, medical products are today produced and supplied through intricate supply chains. On their way to the patient, products go via a number of different entities. They are frequently manufactured in one nation and sent across borders to be promoted or sold in other countries. The ability of national regulatory bodies to oversee the supply chain grows more fragmented, and distribution expands geographically. As a result, there is less effective supply chain oversight, which increases the possibility that substandard or falsified HPT would infiltrate the legitimate supply chain and pose risk to unsuspecting public. This may result in a decline in public trust, which in turn may cause hesitation, poor adherence, and underutilization of health interventions. Patient safety must thus be prioritised when addressing these vulnerabilities and bolstering the supply chain's efficiency and integrity.

In order to improve the near real-time monitoring of the supply chain integrity and the location data of HPT along the supply chain, there is need to embrace traceability technologies, as outlined in this document.