Loan Licenses for Class C & D
(Forms MD-8 & MD-10)
Scale your production of high-risk medical devices efficiently by utilizing existing, fully-compliant licensed manufacturing facilities in India.
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What Are Forms MD-8 & MD-10?
For start-ups or companies lacking their own specialized manufacturing infrastructure, producing high-risk (Class D) or moderate-high risk (Class C) devices presents a massive capital barrier. A Loan License allows you to utilize an existing manufacturer's facility to produce your devices.
Form MD-8: Application
Submitted electronically to the Central Licensing Authority (CLA), this form details your request to manufacture Class C or D devices at a loan facility.
Form MD-10: License
The official Loan License granted by the CLA. It authorizes the legal manufacturing of your high-risk devices at the approved loaned premises.
Strategic Advantages of MD-10
Drastically Reduced Costs
Avoids the massive capital expenditure (CAPEX) required to construct a new, stringent Class C/D compliant manufacturing unit.
Faster Time to Market
By leveraging a facility that already meets complex regulatory demands, you bypass facility construction and initial compliance hurdles.
Unmatched Scalability & Flexibility
Easily adjust production volumes based on market demand, or contract facilities for temporary production boosts without long-term overhead.
The MD-8 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-8 and pay the requisite government base and device-specific fees.
Notified Body Audit
The CLA appoints an approved Notified Body to rigorously audit the actual manufacturing premises.
CLA Scrutiny & Approval
Following a rigorous review of the dossier and the Notified Body's audit report, the CLA issues the MD-10 license.
Streamline Your MD-8 Application
The scrutiny for Class C and D loan licenses is intense. Missing documentation or poorly drafted loanee-licensor agreements can cause months of delays.
- Preparation of robust legal agreements
- MDR 2017 compliant Plant & Device Master Files
- Notified Body audit preparation