Sterilisation licence number made mandatory on medical device labels

The Indian Government has amended the Medical Devices Rules, mandating manufacturers outsourcing sterilisation to mention the sterilisation facility’s licence number on product labels, preceded by “Sterilization Sites Manufacturing License Number”, “Ster. Mfg. Lic. No.” or “S.M.L.” The move strengthens traceability while removing the need for a separate loan licence. Manufacturers get six months to update labels.