India mandates sterilisation facility licence disclosure on medical device labels

India's health regulator has tightened oversight of medical device sterilisation by requiring manufacturers to disclose facility licensing information on product packaging and labelling. The mandate from the Ministry of Health and Family Welfare applies to all manufacturers who contract sterilisation services to third-party facilities rather than conducting the process in-house.

Under the new directive, the licence number of the sterilisation facility must be clearly displayed on medical device labels. This requirement aims to strengthen the traceability of sterilisation processes and ensure that only authorised facilities handle this critical step in device preparation for clinical use.

The measure represents an effort by India's regulatory authorities to improve quality assurance and consumer protection within the medical devices sector. By making facility licensing information visible to healthcare providers and end-users, the government seeks to enhance accountability across the supply chain and reduce the risk of substandard sterilisation practices.

The directive is expected to bring greater consistency to labelling standards across the industry while reinforcing the importance of regulatory compliance among manufacturers. Industry stakeholders will need to update their labelling protocols and documentation systems to align with the new requirements.