How to Obtain CDSCO Loan License for Medical Device Manufacturers in 2025?

How to Obtain CDSCO Loan License for Medical Device Manufacturers in 2025?

A CDSCO Loan License allows a medical device manufacturer who does not own a factory to use another licensed firm’s manufacturing premises, to make or assemble devices legally. In 2025, the rules under Medical Devices Rules, 2017 still allow it, but with stricter oversight and updated documentation requirements.

What is the Loan License under Medical Devices Rules?

CDSCO (Central Drugs Standard Control Organization) regulates medical devices under MDR-2017. (“Loan License” or “Loan Licence”) is a permit for firms that outsource manufacturing. If you lack your own facility, you can partner with one that holds a valid manufacturing license, and apply for loan license. The licensor must make the same kind of device, and must comply with standards.

Why you may need a loan license

Many small firms or startups cannot build full plants early. They may still want to launch products. A loan license lets them do so by using another firm’s facility. It reduces initial investment. It helps with faster market entry while you build your own space later.

Which medical device classes need this license?

Devices under Class C and Class D (higher risk) strictly need manufacturing or loan licence from the Central Licensing Authority (CLA). For Class A and B (lower risk), state licensing authority (SLA) may be responsible depending on device and label. The rules and forms differ per device class.

Read More What is CDSCO Medical Device Import Certificate?

Steps to apply for a loan license (2025 version)

Step 1: Classify your medical device

First check risk class (A, B, C, D) under Schedule I of MDR-2017. Decide whether you need CLA license (for higher risk) or SLA (for lower risk).

Step 2: Find a licenced manufacturer/facility

You must partner with a factory that has valid manufacturing license for the same device category. Prepare a contract/agreement between you and that facility.

Step 3: Prepare required documents

Collect all necessary documents (list below). Ensure they are recent and correct.

Step 4: Application filling on SUGAM portal

Use CDSCO’s SUGAM or other online system. Fill the correct loan license form (MD-8 or as applicable), upload documents, pay fees.

Step 5: Inspection and evaluation

CDSCO or State Licensing Authority inspects the facility where production will happen. They check quality systems, sterility (if needed), technical staff, premises.

Step 6: Grant of loan license

If all documents, inspection, and contract are okay, CDSCO grants loan licence. You can then start manufacturing under that licensed facility legally.

Documents needed (2025 checklist)

You must prepare these documents carefully:

• Application Form MD-8 (or specified loan license form) with accurate details.
• Mutual agreement/contract between applicant and facility.
• Manufacturing License of the manufacturing facility (valid).
• Site Master File / Plant Master File.
• Device Master File including device description, drawings, risk analysis.
• Quality Management System documents (e.g., ISO 13485 if applicable).
• Technical personnel details.
• Test reports of device design/performance.
• Proof of GST, company incorporation, address.
• Sterilization validation reports if the device is sterile.

Fees, timelines and validity

Fees

You must pay application fees to CDSCO, plus inspection fees. Fees vary by class of device, and whether application is for CLA or SLA. Also costs associated to labs, validation, contract legal costs.

Timelines

If everything is ready, CDSCO processes loan license in 4-10 weeks for simple cases. For higher risk devices/device needing sterilization or special validation may take longer. Delays often arise due to lab test backlogs or paperwork mismatch.

Validity & renewal

License typically valid for five years but subject to retention or renewal fee. If any major change in device design, sterilization method, or facility, you may need to re-apply or submit amendment.

Read More MD 15: CDSCO Medical Device Import License?

Obligations after grant

• You must manufacture only at licensed facility.
• Maintain records of production, batch, QA testing.
• Use the contract and agreement documentation for tracing.
• Comply with labeling, packaging, safety and performance norms.
• Allow CDSCO inspections & audits.
• Any change in manufacturing site, technical staff, or design must be notified and sometimes re-validated.

Common hurdles and how to avoid them

Sample case what changed in 2025

A company wanted to outsource sterilization. Earlier they needed separate loan license. After 2025 update, if outsourced facility is already licenced, you may avoid loan license rules for sterilization. But for full manufacturing by another facility the full loan licence still applies. This change came from DTAB and FAQ clarifications. 

Conclusion 

Getting CDSCO Loan License under Medical Devices Rules, 2017 in 2025 is complex but doable. You need correct classification, strong partner facility, full documents, lab tests, inspections. Agile Regulatory helps you through each step. With expert support, you avoid delays and errors. Contact Agile Regulatory to begin your CDSCO loan license journey today; ensure your medical device business grows legally and smoothly.