Abstract

Patient safety is maintained through medical device traceability by enabling precise identification and swift action on faulty or counterfeit products throughout the supply chain. Traceability supports risk reduction in care and recalls of affected devices in cases of defects or adverse events, thereby facilitating timely corrective actions and minimising patient risk. The Central Drugs Standard Control Organization (CDSCO) in India has implemented the Medical Device Rules (MDR), 2017 and has introduced requirements for unique device identifiers (UDIs), marking a significant step towards structured device identification. However, the current framework remains largely labelling-focused with limited digital integration for end-to-end traceability.

This article critically examines India’s regulatory evolution, implementation challenges and the role of GS1 standards in advancing traceability. It argues that global medical device traceability and alignment with best practices will depend on improved international harmonisation, centralised database architecture and regulatory clarity.