Loan Licenses for Class A & B
(Forms MD-4 & MD-6)
Launch your low-to-moderate risk medical devices efficiently by utilizing existing State Licensing Authority (SLA) approved manufacturing facilities.
Consult Our CDSCO Experts
What Are Forms MD-4 & MD-6?
For startups or companies aiming to manufacture Class A or Class B medical devices without investing in their own manufacturing unit, a Loan License is the ideal pathway. It permits you to contract an existing, licensed manufacturer to produce your devices.
Form MD-4: Application
The official application form submitted electronically via the CDSCO portal, requesting a loan license for low-to-moderate risk devices.
Form MD-6: License
The final Loan License issued by the State Licensing Authority (SLA), granting legal authorization to manufacture at the loaned facility.
Strategic Advantages of MD-6
Rapid Time to Market
Bypass the lengthy facility construction and QMS setup phases by leveraging an existing compliant facility.
Capital Efficiency
Eliminates the significant initial capital expenditure (CAPEX) required to establish a new manufacturing unit.
Agile Scalability
Easily adjust production volumes based on market demand by contracting with a loan facility that has available capacity.
The MD-4 Application Workflow
Documentation Compilation
Gather agreements between loanee and licensor, QMS certificates, valid CDSCO Test Licenses, Plant Master Files, and Device Master Files.
Online Submission
Submit MD-4 and pay the requisite government base and device-specific fees via the CDSCO portal.
Notified Body Audit
The SLA appoints an approved Notified Body to audit the actual manufacturing premises.
SLA Scrutiny & Approval
Following a review of the dossier and the audit report, the SLA issues the MD-6 loan license.
Streamline Your MD-4 Application
While Class A & B devices are lower risk, the legal and documentation requirements between the loanee and licensor must be flawlessly executed.
- Preparation of robust legal agreements
- MDR 2017 compliant Plant & Device Master Files
- Seamless SLA communication