India’s medical device industry is rapidly evolving, and regulatory reforms continue to shape a more streamlined and innovation-friendly environment. In a significant move aimed at reducing procedural burdens on manufacturers, the Drugs Technical Advisory Board (DTAB) has approved a key proposal that removes the need for a loan license when outsourcing sterilization—provided certain conditions are met. This update, released as part of the 92nd DTAB meeting held on 24th April 2025, reflects the CDSCO’s ongoing commitment to promote ease of doing business without compromising on patient safety or product quality.
Big Update from CDSCO: No Separate Loan License Required for Sterilization of Medical Devices
In a major regulatory update for India's medical device sector, the Drugs Technical Advisory Board (DTAB), during its 92nd meeting held on 24th April 2025, approved a significant relaxation in the licensing process related to device sterilization.
Disclaimer:
This DTAB recommendation is applicable only to the sterilization process when it is outsourced to a third-party facility licensed under Form MD-3 or MD-9. The exemption from loan license does not apply to other outsourced manufacturing activities or to complete contract manufacturing. For all other such scenarios, the requirement of a loan license remains applicable as per the current Medical Device Rules, 2017. Manufacturers are advised to consult their regulatory experts or CDSCO for case-specific guidance.
What’s the Change?
However, as per the new decision:
- Manufacturers holding a valid Form MD-3/MD-4 or Form MD-9/MD-10 license will no longer need to apply for a separate loan license when getting their devices sterilized at a third-party sterilization facility.
- This relaxation applies only if the third-party sterilization facility is already licensed under Form MD-3 or MD-9.
✅ Conditions to Comply
- Documentary evidence of proper sterilization must be submitted to the Licensing Authority at the time of the manufacturing license application.
- The license number of the sterilization site must be clearly mentioned on the product label.
๐ญ Who Benefits from This?
- Ease compliance for small and medium-sized device manufacturers.
- Speed up market entry by reducing unnecessary paperwork.
- Enhance operational flexibility without compromising product safety or regulatory oversight.
Background
This update follows the recommendations of the DCC Sub-Committee and reflects CDSCO’s move towards risk-based and practical regulation. It shows a shift towards enabling ease of doing business while ensuring product safety.
This reform brings much-needed relief to medical device manufacturers in India, allowing for efficient and regulated outsourcing of sterilization services. As always, compliance with documentation and labeling requirements remains key.
What’s Next?
While the DTAB’s recommendation marks a significant procedural relief, this change is currently based on expert committee consensus. An official amendment to the Medical Device Rules, 2017 is expected in the coming months or years to formally incorporate this exemption and define the compliance obligations in legal terms. Manufacturers should stay alert for draft notifications and future updates from CDSCO, as these will clarify documentation formats, timelines, and enforcement mechanisms associated with sterilization site disclosures. Until then, strict adherence to the current conditions—especially proper labeling and submission of sterilization evidence—will be essential to maintain regulatory compliance.