Procedure for Loan Licence to Manufacture For Sale or for Distribution of Class C or Class D Medical Devices

Aryan Panwar

Aryan Panwar

Published on: Apr 22, 2026

Shatakshi Sharma

Updated on: Apr 22, 2026

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Introduction

Loan license is a legal authorization issued by the Central Drugs Standard Control Organization (CDSCO) that allows an entity without its own manufacturing facility to produce medical devices at the licensed premises of another manufacturer. This further enables companies to manufacture and sell devices by utilizing the existing infrastructure of a third-party manufacturer.

APPLICABLE PROVISIONS

Rules 21, 22, 23, 24, 25 and 29 of Medical Devices Rules, 2017.

ESSENTIAL REQUIREMENTS

While making an application for a grant of a loan license to manufacture for sale or for distribution of a Class C or Class D Medical device, the applicant shall meet the following requirements:

1. Manufacturing site shall comply with the requirements of the Quality Management System as specified under the Fifth Schedule
2. Appoint competent technical staff under whose direction and supervision the manufacturing activity of a medical device shall be undertaken
3. Appoint competent technical staff

DOCUMENTS REQUIRED

Documents to be submitted with the application for the grant of a loan license to manufacture for sale, or for distribution of Class C or Class D medical devices as per Schedule II:

The domestic manufacturer or authorised agent shall submit the following information, duly signed, pertaining to the manufacturing site:

• Constitution details of the domestic manufacturer or authorised agent
• Site or plant master file as specified in Appendix I of this Schedule
• Device master file as specified in Appendix II for medical devices other than in vitro diagnostic medical devices, or Appendix III for in vitro diagnostic medical devices of this Schedule
• Essential Principles checklist for demonstrating conformity to the Essential Principles of Safety and Performance of the Medical Device, including in vitro diagnostic medical device
• Test licence obtained for testing and generation of quality control data (for domestic manufacturers only), if any
• Undertaking signed stating that the manufacturing site is in compliance with the provisions of the Fifth Schedule
• In case of in vitro diagnostic medical devices, a copy of the performance evaluation report issued by the central medical device testing laboratory or medical device testing laboratory registered under Rule 83(3).

PROCESS FOR LICENCE

Applicant shall submit FORM MD-8 along with the fee prescribed below and required documents to obtain a loan license to manufacture, for sale or for distribution of Class C and Class D medical devices from the State Licensing Authority. Upon successful verification of the application and a physical site inspection, the authority will issue the licence via FORM MD-10.

PROCESS OF RENEWAL

Loan Licensee shall renew the license by depositing the license retention fee as specified below before completion of the period of five (5) years from the date of its issue, to the State Licensing Authority:

LICENCE VALIDITY

A Loan Licence issued under Form MD-10 remains valid permanently, provided that the retention fee is paid every five (5) years and is not suspended or cancelled by the Authority. In case the fee is not paid before the due date, a late fee of two per cent (2%) per month will apply for up to one hundred and eighty (180) days. If both the retention and late fees remain unpaid after one hundred and eighty (180) day grace period, the licence will be automatically cancelled.