LOAN LICENCE TO MANUFACTURE FOR SALE – MD10

Medfins International > Services > LOAN LICENCE TO MANUFACTURE FOR SALE – MD10

LOAN LICENCE TO MANUFACTURE FOR SALE OR FOR DISTRIBUTION OF CLASS C OR CLASS D MEDICAL DEVICE

The process for obtaining a Loan Licence to Manufacture for Sale or for Distribution of Class C or Class D Medical Devices in India is governed by the Medical Device Rules, 2017 under the Drugs and Cosmetics Act, 1940. The license is issued in Form MD-10, and the application is submitted in Form MD-8.

Key Indian Medical Device Regulations:

  • The Drugs and Cosmetics Act, 1940 and The Drugs and Cosmetics Rules, 1945
  • Medical Devices Rules, 2017
  • Medical Devices (Amendment) Rules, 2020

The forms required for Manufacturing License in case of class A and B notified medical devices: 

Applicant Type

Application

License

Manufacturer

Form MD-8

Form MD-10

 

Fee Structure:

Subject

Fee (in rupees) INR

Manufacturing licence or loan licence to manufacture Class A (other than non-sterile and non-measuring) or Class B medical device for,-

one site manufacturing

5000

each distinct medical device

500


Process for Loan License (Form MD-10)

  1. Eligibility Check
  • The applicant must be a legal entity (company or individual) with a valid agreement with a licensed manufacturer.
  • The manufacturer must have an appropriate license to manufacture Class C and D medical devices.
  1. Application Submission (Form MD-8)
  • The applicant (loan licensee) must apply to the Central Licensing Authority (CLA) (CDSCO).
  • The application should be submitted through the CDSCO’s online portal.
  1. Documents Required
  • Covering letter.
  • Duly filled Form MD-8.
  • Copy of manufacturing license of the manufacturer showing that their facility is licensed for manufacturing of the same device (s).
  • Quality Management System (QMS) documents in compliance with ISO 13485:2016.
  • Loan License Agreement between the applicant and the licensed manufacturer.
  • List of medical devices with intended use, risk classification, and technical details.
  • Device Master File (DMF) and Plant Master File (PMF) (if applicable).
  • Test reports from accredited laboratories.
  • Site layout and facility details and other technical documents.
  1. Inspection by Licensing Authority
  • The CDSCO may conduct an inspection of the manufacturing facility to verify compliance with quality and safety standards.
  1. Grant of Loan Licence (Form MD-10)
  • If the application is satisfactory, CDSCO issues the loan license in Form MD-10.
  • The loan license allows the applicant to manufacture medical devices using the licensed manufacturer’s facility.
  1. Post-Licensing Compliance
  • Any changes in manufacturing conditions or agreement must be notified to CDSCO.

FAQs:

  • Does a Loan Licensee need a separate ISO 13485 certification?

Not necessarily, but the Loan Licensee must operate under a facility that is ISO 13485 certified and follows regulatory compliance.

  • Can the Loan Licence be transferred to another manufacturer?

No, a Loan Licence is specific to the applicant and the manufacturing site and cannot be transferred to another entity.

  • Can a foreign manufacturer apply for a Loan Licence in India?

No, only Indian entities can apply. However, foreign manufacturers can partner with an Indian loan licensee to manufacture their medical devices in India.

How can Medfins Help you?

As a regulatory consultant, we assist in the Loan Licence (Form MD-10) application process by the following services:

  1. Regulatory Strategy & Consultation
  • Identify the regulatory classification of the medical device.
  • Guide clients on compliance with Medical Device Rules, 2017 and ISO 13485:2016.
  • Advise on documentation requirements and legal agreements.
  1. Application Preparation & Submission
  • Prepare and submit Form MD-8 through the CDSCO Sugam portal.
  • Ensure proper Device Master File (DMF) and Plant Master File (PMF) documentation.
  • Assist in compiling Quality Management System (QMS) documentation.
  1. Loan Licence Agreement & Manufacturer Compliance
  • Draft the Loan License Agreement between the applicant and manufacturer.
  • Verify the manufacturing site’s GMP compliance and other regulatory requirements.
  1. Pre-Inspection Support
  • Conduct internal audits to ensure the manufacturing facility is inspection-ready.
  • Provide guidance on addressing potential compliance gaps before CDSCO’s audit.
  1. Liaison with Regulatory Authorities
  • Act as a point of contact between the client and CDSCO/SLA for queries and clarifications.
  • Follow up on application progress and address any objections.
  1. Post-Licensing Compliance & Maintenance
  • Guide on post-market obligations, adverse event reporting, and license renewal.
  • Support in maintaining compliance with Indian medical device regulations.