Indian Regulators Ease Medical Device Sterilization Norms

The Drugs Consultative Committee (DCC) first deliberated on this matter in June 2023, subsequently forming a sub-committee for an in-depth examination. The sub-committee’s recommendations, finalized after reviewing all aspects of Quality Management Systems (QMS), suggested that the loan license requirement was unnecessary, provided the final product was released from the actual manufacturing site following comprehensive Quality Control (QC) checks. They proposed that such outsourcing could be facilitated through mutual third-party agreements, contingent on the sterilization facility possessing a valid license for the specific medical device.

Crucially, recognizing sterilization as a critical activity, the sub-committee also recommended that the device label must include the license number of the outsourced sterilization site. This provision was suggested for inclusion in Rule 44 of the Medical Device Rules, 2017, as part of the labeling requirements.

These recommendations were subsequently placed before the 65th DCC meeting on December 20, 2024. The DCC concurred with the sub-committee’s findings but added a vital condition: manufacturers must submit appropriate documentary evidence to the Licensing Authority prior to obtaining their manufacturing license to substantiate the outsourced sterilization activity. This evidence would include the mutual agreement between the device manufacturer and the sterilization site, as well as QMS documents like the Plant Master File and Device Master File detailing the outsourced process. The DCC also reinforced the labeling requirement for the sterilization site’s license number.

The final consensus was reached at the 92nd Drugs Technical Advisory Board (DTAB) meeting held on April 24, 2025, which fully agreed with the DCC’s recommendations.

This regulatory clarification aims to reduce the compliance burden on medical device manufacturers while reinforcing accountability and transparency in the supply chain. By removing the loan license requirement but mandating robust documentation and clear labeling, the authorities seek to ensure that product quality and patient safety remain paramount.

The Drugs Controller General of India (DCGI) has disseminated this information to all Zonal and sub-zonal offices of CDSCO and to all stakeholders in the Medical Device Industry, urging necessary action to comply with the updated requirements.

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