In the pharmaceutical and medical device industries, the term “Loan Licence” refers to a manufacturing arrangement in which one company (the Licensor) grants permission to another company (the Licensee) to use its facilities, processes, and technology to manufacture a product.

A licence may be required by medical device manufacturers who intend to sell or distribute their products in a new market but do not already have a physical presence there or established distribution channels.

A loan license allows the manufacturer to grant a temporary license to a third-party distributor or importer, who will then distribute the medical device in the authorized region. This can be an attractive option for manufacturers who want to test the market before investing in a more permanent presence or for those who are looking to expand their reach without committing to a long-term investment.

Types Of Forms

Class Of Device 

Form Type 

Licensing Authority 

Class A & Class B MD-4 form & granted in MD-6 State Licensing Authority
Class C & Class D MD-8 & granted in MD-10.  Central Licensing Authority

Applied Govt. Fees

Class of device

Description of manufacturing
licence fee

Fees

Class A & Class B One site ₹5000
Each distinct medical device ₹500
Class C & DOne site ₹50000
Each distinct medical device ₹1000

Basic List Of Document Required For Grant Of Loan Licence

Constitution of the firm
The Establishment/Site ownership/Tenancy Agreement.
Quality Certificate in respect of manufacturing sites
Copy of Certificate supporting quality managements system (ISO: 13485)
Plant Master file from the Manufacturer
Device Master File from the Manufacturer
Test Licences obtained for testing and generation of quality control data.
Undertaking signs stating that the manufacturing site is in compliance with the provision of the
fifth schedule.

Fees Challan
Legal Form (Digital Sign Mandatory)

Timeline

It takes approx 90 to 120 working days.