Centre Mandates Sterilisation Subcontractor Disclosure on Medical Device Labels
· Business · Business Standard
The Union government has issued a directive requiring medical device manufacturers to explicitly disclose the names and addresses of subcontractors involved in sterilisation processes on product labels. This mandate aims to enhance traceability and accountability within the medical device supply chain. Companies must now ensure that any third-party facility performing sterilisation is clearly identified on the packaging. The move follows concerns regarding the safety and quality control of devices that undergo outsourced processing. Manufacturers are expected to comply with these updated labelling standards to maintain regulatory approval for their products in India.
Why it matters
This mandate increases transparency for healthcare providers and patients by ensuring that every entity involved in the critical sterilisation of medical devices is identifiable, thereby improving safety oversight.
Read the original report — Business Standard
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