Import License for Medical Devices in India: Procedure

Deepti Mudgal

Deepti Mudgal

Published on: Mar 27, 2026

Shatakshi Sharma

Updated on: Mar 27, 2026

Introduction

An Import License for Medical Devices is an important regulatory document, as it acts as a formal permission to bring foreign medical products into the country. This license is required to legally bring medical devices, instruments, and in-vitro diagnostics from overseas into the country.

APPLICABLE PROVISIONS

Rule 34, 36 of Medical Devices Rules, 2017

DOCUMENTS REQUIRED

Documents to be submitted with the application for grant of Import Licence or licence to manufacture for sale or for distribution of a 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	A 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 (IFU, etc.), user manual, wherever applicable	Manual, wherever applicable, labels and package inserts (IFU, 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 to be submitted with the application for grant of licence to manufacture or import Class B, Class C or Class D medical device –

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

Constitution details of the manufacturer or agent
Site or plant master file (Appendix I)
Device master file (Appendix II for medical devices or Appendix III for IVDs)
Essential Principles safety and performance checklist
Domestic test licenses and quality control data, if any
Signed undertaking of Fifth Schedule compliance
Overseas site registration (notarized copy) and Free Sale Certificate from the country of origin as per rule 36
Notarized copy of Quality Management System or Quality Assurance certificates for the manufacturing site
Valid wholesale or manufacturing license issued under these rules (self-attested copy)
Latest inspection/audit report (from the last 3 years, if any) by a Notified Body or Regulatory Authority
For in vitro diagnostic medical devices, a performance evaluation report from a registered laboratory

PROCESS FOR LICENSE

Applicant shall submit Form MD-14 along with the prescribed fee given below and required documents to obtain import license for medical devices from the Central Licensing Authority, the license will be issued through Form MD-15.

Particulars	Fees payable ($)
Import licence for Class A medical device other than in vitro diagnostic medical device for:
(A) One site	$1000
(B) Each distinct medical device	$50
Import licence for Class B medical device other than in vitro diagnostic medical device for
(A) One site	$2000
(B) Each distinct medical device	$1000
Import licence for Class A or Class B in vitro diagnostic medical device for:
(A) One site	$1000
(B) Each distinct than in vitro diagnostic medical device	$10
Import licence for Class C or Class D medical device other than in vitro diagnostic medical device for:
(A) One site	$3000
(B) Each distinct medical device	$1500
Import licence for Class C or Class D in vitro diagnostic medical device for:
(A) One site	$3000
(B) Each distinct than in vitro diagnostic medical device	$500

PROCESS OF RENEWAL

The import license for medical devices shall continue to remain valid without the need for a separate renewal application, provided the licensee deposits the license retention fee as specified in the Second Schedule at intervals of every five years from the date of issue. Updated documents should be submitted only if there are changes to the device, manufacturing site, or other relevant information.

VALIDITY OF LICENSE

The license valid in perpetuity i.e., permanently, as long as the payment of license retention fee is done from time to time, as specified in the Second Schedule. The license retention should be paid each time before completion of the period of 5 years from the date of issue of the license unless it is suspended or cancelled by the Central Licensing Authority.

Procedure for Import License for Medical Devices								
Introduction
An Import License for Medical Devices is an important regulatory document, as it acts as a formal permission to bring foreign medical products into the country. This license is required to legally bring medical devices, instruments, and in-vitro diagnostics from overseas into the country.
APPLICABLE PROVISIONS
Rule 34, 36 of Medical Devices Rules, 2017
DOCUMENTS REQUIRED
Documents to be submitted with the application for grant of Import Licence or licence to manufacture for sale or for distribution of a 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
            A 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 (IFU, etc.), user manual, wherever applicable
            Manual, wherever applicable, labels and package inserts (IFU, 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 to be submitted with the application for grant of licence to manufacture or import Class B, Class C or Class D medical device -
The domestic manufacturer or authorised agent shall submit the duly signed following information pertaining to Manufacturing site:

Constitution details of the manufacturer or agent
    Site or plant master file (Appendix I)
    Device master file (Appendix II for medical devices or Appendix III for IVDs)
    Essential Principles safety and performance checklist
    Domestic test licenses and quality control data, if any
    Signed undertaking of Fifth Schedule compliance
    Overseas site registration (notarized copy) and Free Sale Certificate from the country of origin as per rule 36
    Notarized copy of Quality Management System or Quality Assurance certificates for the manufacturing site
    Valid wholesale or manufacturing license issued under these rules (self-attested copy)
    Latest inspection/audit report (from the last 3 years, if any) by a Notified Body or Regulatory Authority
    For in vitro diagnostic medical devices, a performance evaluation report from a registered laboratory

PROCESS FOR LICENSE
Applicant shall submit Form MD-14 along with the prescribed fee given below and required documents to obtain import license for medical devices from the Central Licensing Authority, the license will be issued through Form MD-15.

Particulars
            Fees payable ($)
        
        
            Import licence for Class A medical device other than in vitro diagnostic medical device for:
        
        
            (A) One site
            $1000
        
        
            (B) Each distinct medical device
            $50
        
        
            Import licence for Class B medical device other than in vitro diagnostic medical device for
        
        
            (A) One site
            $2000
        
        
            (B) Each distinct medical device
            $1000
        
        
            Import licence for Class A or Class B in vitro diagnostic medical device for:
        
        
            (A) One site
            $1000
        
        
            (B) Each distinct than in vitro diagnostic medical device
            $10
            
        
            Import licence for Class C or Class D medical device other than in vitro diagnostic medical device for:
        
        
            (A) One site
            $3000
        
        
            (B) Each distinct medical device
            $1500
            
        
            Import licence for Class C or Class D in vitro diagnostic medical device for:
        
        
            (A) One site
            $3000
        
        
            (B) Each distinct than in vitro diagnostic medical device
            $500

PROCESS OF RENEWAL
The import license for medical devices shall continue to remain valid without the need for a separate renewal application, provided the licensee deposits the license retention fee as specified in the Second Schedule at intervals of every five years from the date of issue. Updated documents should be submitted only if there are changes to the device, manufacturing site, or other relevant information.
VALIDITY OF LICENSE
The license valid in perpetuity i.e., permanently, as long as the payment of license retention fee is done from time to time, as specified in the Second Schedule. The license retention should be paid each time before completion of the period of 5 years from the date of issue of the license unless it is suspended or cancelled by the Central Licensing Authority.

Industry Specific

Procedure for Import License for Medical Devices