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India: Streamlining Sterilization Outsourcing for Medical Device Manufacturers

The Medical Device Rules, 2017 (MDR-2017) have been instrumental in ensuring the quality and safety of medical devices in India. However, one area that has raised concerns among manufacturers is the regulatory requirements for outsourcing sterilization activities.


Sterilization is a critical process in medical device manufacturing and ensuring compliance while outsourcing this activity has been a point of discussion. Recently, the Drugs Consultative Committee (DCC) and other regulatory bodies have reviewed the existing framework and recommended key changes to simplify the process.


Previously, manufacturers outsourcing sterilization to a third-party facility were required to obtain a loan license which is a regulatory hurdle added to the complexity of the process. Stakeholders argues that since the final product release happens at the manufacturers’ site with full quality control checks, the additional loan license requirement was redundant.


Key Recommendations by the Sub-Committee (2023)

After thorough deliberation, a DCC sub-committee made the following recommendations in June 2023:

  • No Mandatory Loan License

    • Since the final QC release is done by the manufacturer, a loan license should not be mandatory

    • Sterilization can be outsourced via a third-party agreement, provided the sterilization facility holds a valid MDR-2017 license for the process

  • Sterilization Facility Must Have a Valid License

    • The facility performing sterilization must hold a valid license for the specific medical device category that the original manufacturer is licensed to produce

  • Labelling Requirements for Sterilization Outsourcing

    • Given the critical nature of sterilization, the license number of the sterilization facility should be mentioned on the device label

    • Rule 44 of MDR-2017 should be amended to include this labelling requirement


DCC Approval & Further Recommendations (December 2024)

The 65th DCC meeting (December 2024) accepted these recommendations with an additional requirement:

  • Manufacturers must submit documentary evidence (example: third-party agreement, QMS documents) to the Licensing Authority before obtaining a manufacturing license


Final Approval by DTAB (April 2025)

The 92nd Drug Technical Advisory Board (DTAB) meeting on April 2025 endorsed these changes paving the way for a more streamlined sterilization outsourcing process.


What Does This Mean for Manufacturers?

  • No more loan license requirement for outsourced sterilization

  • Clear third-party agreements & QMS documentation must be submitted

  • Sterilization facility’s license number must appear on the device label


This regulatory update reduces compliance burdens while maintaining strict quality control for medical device sterilization. Manufacturers should ensure proper documentation and labelling to align with the new guidelines.

 

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