Last Updated on July 25, 2025 by The Health Master
Sterilization
In a move to streamline operations and increase efficiency within the medical devices industry, the Central Drugs Standard Control Organisation (CDSCO) has issued an important directive regarding the sterilization of medical devices.
This new guidance, informed to all State and Union Territory drug controllers, clarifies that a “loan license” will no longer be a mandatory requirement for outsourced sterilization of medical devices.
Importance of the change:
For a long time, medical device manufacturers have raised this issue regarding the mandatory “loan license” for outsourcing sterilization of medical devices.
This requirement often presented logistical hurdles and additional regulatory steps as per the Medical Devices Rules (MDR), 2017.
This important decision comes from a sub-committee, established by the Drugs Consultative Committee (DCC) in June 2023.
Thorough examination of the issue by DCC, followed by an agreement from the Drugs Technical Advisory Board (DTAB) in April 2025, is a result of a well-considered and collaborative effort to amend medical device regulations.
Ensuring Quality:
While the “loan license” requirement has been relaxed, the emphasis on maintaining medical device quality control remains important.
The sub-committee, after in-depth deliberation, concluded that from a Quality Management System (QMS) perspective, a loan license isn’t essential when the final product is released from the actual manufacturing site.
The core principle here is that the primary manufacturer retains full responsibility for monitoring the entire quality control process before the device is released to market.
This outsourcing strategy for sterilization activities can now be effectively managed through a mutual third-party agreement between the device manufacturer and the sterilization facility.
Crucially, the facility performing the sterilization must possess a valid license to carry out such processes under the existing rules.
New Labeling Requirements:
Keeping in view the critical nature of medical device sterilization, the CDSCO, in alignment with the recommendations, has introduced new labeling requirements for the medical devices.
The manufacturers will now need to mention at least the license number of the sterilization site on the device label itself to ensure medical device traceability and transparency.
The Journey of Key Decisions
June 2023: A sub-committee is constituted by the Drugs Consultative Committee (DCC) to examine the concerns regarding loan licenses for outsourced sterilization.
December 20, 2024: The DCC approves the sub-committee’s recommendations, mentioning the need for robust documentary evidence submitted to the licensing authority before obtaining a medical device manufacturing license. This evidence should include mutual agreements and detailed QMS documents.
April 24, 2025: The DCC’s recommendations are forwarded to the Drugs Technical Advisory Board (DTAB).
April 24, 2025 (Same Day): The DTAB fully agreed with the recommendations for the official notification.
Q: What is the change regarding the “loan license” for medical device sterilization?
A: The CDSCO has clarified to state and UT drug controllers that a “loan license” is no longer strictly required for medical device firms that outsource their sterilization activities to another facility, provided that facility has a valid license to perform such sterilization for the medical devices.
Q: What documents are required for outsourcing the sterilization process now?
A: Manufacturers should have a mutual third-party agreement with the sterilization facility. Further, documentary evidence, including details of the outsourced activity within the manufacturer’s QMS document, must be submitted to the licensing authority prior to obtaining the manufacturing license.
Disclaimer: This article contains information obtained from the source mentioned below. Our team made changes in the format to rewrite and present the news or article in a unique format.
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