Loan Licence for Class A & B Medical Devices in India

Aryan Panwar

Aryan Panwar

Published on: Apr 20, 2026

Shatakshi Sharma

Updated on: Apr 20, 2026

★★★★★(1 Rating)

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 20, 22, 29 of Medical Devices Rules, 2017.

ESSENTIAL REQUIREMENTS

While making application for grant of loan license to manufacture for sale or for distribution of Class A and Class B Medical device, the applicant shall meet the following requirements:

manufacturing site shall comply with the requirements of the Quality Management System as specified under the Fifth Schedule
appoint competent technical staff under whose direction and supervision the manufacturing activity of a medical device shall be undertaken
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 A medical device:

S.NO.	For medical devices other than in vitro diagnostic medical device	For in vitro diagnostic medical device
1	Device description, intended use of the device, specification including variants and accessories	Device description, intended use of the device, specification including variants and accessories
2	Material of construction	Summary of analytical technology, relevant analytes and test procedure
3	Working principle and use of a novel technology (if any);	working principle and use of a novel technology (if any);
4	Labels, package inserts (instructions for use or electronic instructions for use, etc.), user manual, wherever applicable	Labels and package inserts (instructions for use or electronic instructions for use, etc.), user manual, wherever applicable
5	Summary of any reported Serious Adverse Event in India or in any of the countries where device is marketed and action taken by the manufacturer and National Regulatory Authority concerned	Analytical performance summary including sensitivity and specificity
6	Site or plant master file as specified in Appendix I of this Schedule	Site or plant master file as specified in Appendix I of this Schedule
7	Constitution details of the firm (of domestic manufacturer or authorised agent)	Constitution details of the firm (of domestic manufacturer or authorised agent)
8	Essential principles checklist for demonstrating conformity to the essential principles of safety and performance of the medical device;	Essential principles checklist for demonstrating conformity to the essential principles of safety and performance of the in vitro medical device;
9	Undertaking signed by the manufacturer stating that the manufacturing site is in compliance with the provisions of the Fifth Schedule	Undertaking signed by the manufacturer stating that the manufacturing site is in compliance with the provisions of the Fifth Schedule

Documents too be submitted with the application for grant of loan license to manufacture for sale or for distribution of Class B medical device:

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

Constitution details of 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

PROCESS FOR LICENCE

Applicant shall submit FORM MD-4 along with the fee prescribed below and required documents to obtain loan license to manufacture for sale or for distribution of Class A and Class B Medical device 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-6.

S.NO.	Particulars	Fees
Loan licence to manufacture 28 Class A (other than non-sterile and non-measuring)] or Class B medical device for:
1	One site; and	5000
2	Each distinct medical device	500

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:

S.NO.	Particulars	Fees
Loan licence retention fee for:
1	one site manufacturing Class A (other than non-sterile and non-measuring) or Class B medical device	5000
2	Each distinct medical device of Class A (other than nonsterile and non-measuring) or Class B	5000

LICENCE VALIDITY

A Loan Licence issued under Forms MD-5, remains valid indefinitely provided that the retention fee is paid in every five (5) years and are not suspended or cancelled by the Authority. In Case, the fee is not paid before due date, a late fee of two percent (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) days grace period, the licence will be automatically cancelled.

Procedure for Loan License to Manufacture for Sale or For Distribution of Class A and Class B Medical Devices								
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 20, 22, 29 of Medical Devices Rules, 2017.
ESSENTIAL REQUIREMENTS
While making application for grant of loan license to manufacture for sale or for distribution of Class A and Class B Medical device, the applicant shall meet the following requirements:

manufacturing site shall comply with the requirements of the Quality Management System as specified under the Fifth Schedule
    appoint competent technical staff under whose direction and supervision the manufacturing activity of a medical device shall be undertaken
    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 A medical device:

S.NO.
          For medical devices other than in vitro diagnostic medical device
          For in vitro diagnostic medical device
       
       
          1
          Device description, intended use of the device, specification including variants and accessories
          Device description, intended use of the device, specification including variants and accessories
        
        
            2
            Material of construction
            Summary of analytical technology, relevant analytes and test procedure
        
        
            3
            Working principle and use of a novel technology (if any);
            working principle and use of a novel technology (if any);
        
        
            4
            Labels, package inserts (instructions for use or electronic instructions for use, etc.), user manual, wherever applicable
            Labels and package inserts (instructions for use or electronic instructions for use, etc.), user manual, wherever applicable
        
        
            5
            Summary of any reported Serious Adverse Event in India or in any of the countries where device is marketed and action taken by the manufacturer and National Regulatory Authority concerned
            Analytical performance summary including sensitivity and specificity
        
        
            6
            Site or plant master file as specified in Appendix I of this Schedule
            Site or plant master file as specified in Appendix I of this Schedule
        
        
            7
            Constitution details of the firm (of domestic manufacturer or authorised agent)
            Constitution details of the firm (of domestic manufacturer or authorised agent)
        
        
            8
            Essential principles checklist for demonstrating conformity to the essential principles of safety and performance of the medical device;
            Essential principles checklist for demonstrating conformity to the essential principles of safety and performance of the in vitro medical device;
        
        
            9
            Undertaking signed by the manufacturer stating that the manufacturing site is in compliance with the provisions of the Fifth Schedule
            Undertaking signed by the manufacturer stating that the manufacturing site is in compliance with the provisions of the Fifth Schedule

Documents too be submitted with the application for grant of loan license to manufacture for sale or for distribution of Class B medical device:
The domestic manufacturer or authorised agent shall submit the duly signed following information pertaining to manufacturing site:

Constitution details of 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

PROCESS FOR LICENCE
Applicant shall submit FORM MD-4 along with the fee prescribed below and required documents to obtain loan license to manufacture for sale or for distribution of Class A and Class B Medical device 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-6.

S.NO.
          Particulars
          Fees
       
       
        Loan licence to manufacture 28 Class A (other than non-sterile and non-measuring)] or Class B medical device for:
       
       
          1
          One site; and
          5000
        
        
            2
            Each distinct medical device
            500

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:

S.NO.
          Particulars
          Fees
       
       
        Loan licence retention fee for:
       
       
          1
          one site manufacturing Class A (other than non-sterile and non-measuring) or Class B medical device
          5000
        
        
            2
            Each distinct medical device of Class A (other than nonsterile and non-measuring) or Class B
            5000

LICENCE VALIDITY
A Loan Licence issued under Forms MD-5, remains valid indefinitely provided that the retention fee is paid in every five (5) years and are not suspended or cancelled by the Authority. In Case, the fee is not paid before due date, a late fee of two percent (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) days grace period, the licence will be automatically cancelled.

Industry Specific

Procedure for Loan License to Manufacture for Sale or For Distribution of Class A and Class B Medical Devices