CDSCO 2025 Update: Loan License No Longer Required for Medical Device Sterilization

CDSCO loan license for medical devices was once a mandatory approval for companies that didn’t own a manufacturing or sterilization unit. It allowed them to legally manufacture or sterilize their products by partnering with a licensed third-party facility. However, the CDSCO 2025 update states that medical device manufacturers no longer need to license if they are using an already licensed sterilization facility. This change is to decrease unnecessary documentation, speed up product approvals, and promote ease of doing business while still maintaining high safety standards. 

What is The CDSCO Loan License for Medical Devices?

A CDSCO Loan License is an approval that allows a company (that does not own a manufacturing unit) to legally manufacture medical devices by using another company’s registered manufacturing facility. You can understand it as if you want to sell your brand of medical devices but don’t have your factory. You could use another manufacturer’s facility with their permission, and for that, you need a license from the CDSCO.

What Role Did the Loan License Play in Medical Device Sterilization Before 2025?

Before 2025, the CDSCO loan license is important in medical device sterilization for companies that do not own sterilization plants. In simple words, if a medical device company wanted to sterilize its products using someone else’s facility, it had to apply for a license to do so legally.

• The medical device owner used a third-party sterilization facility.
• To follow the CDSCO rules, they needed a license for that facility.
• The loan license made sure that even outsourced sterilization was regulated safely and properly documented. 
• It was issued under the form MD 6 and linked to the manufacturer’s holding a form MF 5 license.

What is the 2025 CDSCO Update About the Loan License Requirement?

S.No.	Aspect	Before 2025	After 2025 Updates
1.	Loan License Requirement	Mandatory to have a loan license (form MD 6/MD 8) for sterilization	No longer required if the sterilization facility is already licensed
2.	Who Needed the License	Medical device companies that outsourced sterilization to third-party units	Not needed if the third-party sterilizer is already CDSCO licensed
3.	Applicable Form	Form MD 6 (for own brands) or MD 8 (for loan license)	No additional form required if outsourcing to a licensed sterilizer
4.	Sterilization Facility Conditions	It could be owned or third-party, but a loan license was compulsory	A third-party facility should hold a valid manufacturing license from the CDSCO
5.	Purpose of Rule	Ensure better control and traceability	Ease of doing business and reducing redundant approvals
6.	Still Need CDSCO Oversight?	Yes	Yes
7.	Impact on Manufacturers	An extra step and paperwork are required to obtain a loan license	Faster approvals, lower compliance burden, less documentation

Why Has CDSCO Removed the Loan License Requirement for Sterilization in 2025?

Here, check the pointer to know why CDSCO removed the loan license requirements for sterilization in 2025:

• To Simplify the Process – Earlier, manufacturers had to apply for a license if they wanted to outsource sterilization. Now this extra step has been removed to make the compliance process quicker and smoother.
• No Companies on Safety – Even though the loan license is not required for anyone, the sterilization should still be done at a facility that holds a valid license for sterilization under the Medical Device Rules, 2017. So the product safety and hygiene standards will be maintained.
• Industry Demands – Many manufacturers felt the loan license was an unnecessary burden, especially when outsourcing to already approved and licensed sterilization facilities. CDSCO took this feedback seriously.
• Based on Expert Recommendation – The change was made after careful review and approval by DTAB, which are top-level regulatory bodies.

What Does the CDSCO 2025 Update Mean for Medical Device Manufacturers?

• Easier outsourcing of sterilization – You no longer need a separate loan license if you’re sending a device to a facility that already has CDSCO approval for sterilization.
• Faster Time to Market – By skipping the loan license step, you save time and avoid extra paperwork, which speeds up production and distribution.
• No Compromise on Quality – Sterlization should still take place at a CDSCO-licensed facility, and compliance standards remain intact.
• Cost Savings – Eliminating the loan license reduces application fees and administration costs, making processes more efficient and budget-friendly.

Documents Required Instead of a Loan License in 2025

• Mutual Agreement
• Manufacturing Site License of Sterlizer
• Sterlizer Details on Product Label
• Evidence of Sterlization Process
• Plant Master File
• Device Master File
• Quality Assurance Documents
• Sterilization batch records
• Sterlization Certificate
• Process Validation and Verification Reports
• Risk management file
• Environmental monitoring records
• Declaration from the manufacturers

How Can Regulatory Consultants Help With CDSCO in 2025?

Regulatory consultants are important in helping businesses deal with CSCO compliance smoothly, especially with changing rules like the CDSCO 2025 updates on the loan license for sterilization.

• Understand the latest CDSCO updates
• Documents Preparation & Review
• Coordination with Sterilization Vendors
• Regulatory Filing & Application Support
• Label Compliance Check
• Audit & Inspection Readiness
• QMS & Risk File Guidance
• Avoid Delays and Penalties