How long does it take to get the MD-15 license?

The standard timeline is 6 to 9 months after submitting a complete application, depending on document quality and query response time.

Can I modify my MD-15 license?

Yes. Modifications are allowed to add devices or update manufacturer and agent details through CDSCO approval.

Are refurbished medical devices allowed under MD-15?

No. Only new medical devices with valid regulatory approvals are allowed for import into India.

CDSCO MD-15 License: Step-by-Step Guide for Medical Device Import in India

Importing a medical device into India is not as simple as shipping a product and putting it on a shelf. India's healthcare market is one of the fastest-growing in the world. It is already the 4th largest medical device market in Asia and the government takes safety very seriously. Before any medical device can legally enter and be sold in India, the importer must obtain a CDSCO medical device license, officially known as the MD-15 license. Without it, you cannot import, sell, or distribute your device in India no matter how well-known it is in other countries.

The challenge is that the process involves multiple government forms, a long checklist of documents, inspections, and queries from regulatory authorities. Many foreign manufacturers and even Indian importers find the system confusing and end up with delays, rejections, or penalties. At PSR Compliance, we simplify this entire journey. We help you understand exactly what you need, prepare every document correctly, file your application on the CDSCO portal, and respond to any government queries so you get your MD-15 medical device import license faster, with fewer headaches.

What Is the MD-15 License?

The MD-15 license is the official import license for medical devices in India. It is issued by the Central Drugs Standard Control Organization (CDSCO), which works under the Ministry of Health and Family Welfare (MoHFW). This license is based on the Medical Devices Rules, 2017.

Think of the MD-15 as a "green light" from the Indian government. Once you have it, you are legally allowed to bring your medical device into India and sell it here. Without an MD-15 license, importing medical devices is illegal and can result in heavy fines and seizure of your products.

Which Medical Devices Need the MD-15 License?

Not every single device needs this license, but most do. Here is a simple breakdown:

Medical Device Class	MD-15 License Required	Examples
Class A Sterile Devices	Yes	Sterile bandages, sterile surgical gloves, sterile dressings, sterile cotton swabs
Class A Measuring Devices	Yes	Thermometers, blood glucose meters, weighing scales used for medical purposes
Class B Devices	Yes	Blood pressure monitors, needles, syringes, suction equipment, infusion pumps
Class C Devices	Yes	Catheters, orthopedic implants, artificial heart valves, dialysis equipment
Class D Devices	Yes	Pacemakers, ventilators, heart-lung machines, implantable defibrillators

Devices that DO NOT need an MD-15 license

Medical Device Class	MD-15 License Required	Detailed Products / Examples
Class A Non-Sterile & Non-Measuring Devices	No	Basic tongue depressor, plain bandage, non-sterile examination tools, simple medical trays
Registration Requirement	CDSCO Medical Device Registration Only	These devices only need a CDSCO medical device registration, which is a simpler process
Need Help With Classification?	Support Available	Not sure which class your device falls under? That is the very first step and we can help you figure it out quickly.

Understanding the Four Device Classes

India classifies medical devices into four risk levels under the Medical Devices Rules, 2017:

Class A - Low Risk

Examples : stethoscopes, plain bandages, tongue depressors
These cause little to no harm if used correctly.

Class B - Low to Moderate Risk

Examples : blood pressure monitors, syringes, needles
These can cause harm if used incorrectly.

Class C - Moderate to High Risk

Examples: catheters, orthopedic implants, dialysis machines
These could cause serious injury if they malfunction.

Class D - Highest Risk

Examples: pacemakers, ventilators, heart-lung machines
Failure of these devices can directly lead to death.

The higher the class, the more documents and scrutiny are required for your CDSCO medical device license.

Who Is Eligible to Apply?

This section explains exactly who can apply, what conditions must be met, and what pre-requirements are necessary before you can even submit your application. Meeting all eligibility criteria upfront avoids rejections.

Indian Importers or Wholesale Distributors

Must be a legally registered business entity in India (Pvt Ltd, LLP, Proprietorship, etc.)
Must hold a valid Wholesale Drug License or Wholesale Medical Device License (Form MD-42) from the State Licensing Authority.
Must have a physical office or storage premises in India for device storage and distribution.
Must be willing to take legal responsibility for the devices imported under their license.

Indian Authorized Agents (IAAs) Acting for Foreign Manufacturers

Must hold a valid Form MD-42 wholesale license for medical devices.
Must have a legally executed Power of Attorney from the foreign manufacturer, notarized and apostilled.
Must be ready to sign an undertaking (as per Part I of the Fourth Schedule of MDR 2017) confirming they will comply with all Indian medical device regulations on behalf of the foreign manufacturer.
Must maintain regular communication with CDSCO and handle all queries, inspections, and compliance obligations within India.

Foreign Medical Device Manufacturers

Cannot apply directly, must route their application through a licensed Indian Authorized Agent.
Must have a valid manufacturing license from their home country's regulatory authority.
Must hold an ISO 13485 certificate (international quality management standard for medical device manufacturers).
Must have a Free Sale Certificate (FSC) issued by the National Regulatory Authority (NRA) of their home country, proving the device is legally sold in that country.
Devices must preferably be approved in reference countries: USA, UK, EU, Canada, Japan, or Australia (this can speed up CDSCO review).
Must be willing to allow CDSCO to inspect the overseas manufacturing facility if required (inspection fee: $6,000).

Research Institutions and Academic Bodies in India

Must be a recognized Indian institution (university, government research body, or approved private research organization).
Can import devices in limited quantities only for clinical trials, research, or testing purposes not for sale.
Must have ethics committee approval for clinical investigations involving the device.
May need to apply for a Test License (Form MD-16/MD-17) instead of a full MD-15, depending on quantity and purpose.

Hospitals and Healthcare Providers

Eligible to import specialized medical devices or custom-made devices for direct patient use.
Must be a licensed healthcare facility under applicable state or central health regulations.
Devices imported must be for patient care use only. not for resale or distribution.
Must maintain records of device usage and report any adverse events to CDSCO.

Important for Foreign Companies

If you are a company outside India, you cannot submit your application yourself. You must appoint an Indian Authorized Agent.
This agent must have a valid wholesale license.
They will act as your official representative in front of CDSCO.

Key Conditions That All Applicants Must Meet

Legal business registration : Your entity must be properly registered in India under applicable law
Valid wholesale license : The applicant or their Indian agent must hold Form MD-42 before applying for MD-15, you cannot apply for both simultaneously; the wholesale license must come first.
Device must be notified : The medical device you wish to import must be listed under CDSCO's notified medical devices list. If it is not yet notified, a separate process applies.
QMS compliance : The overseas manufacturer must follow a Quality Management System compliant with ISO 13485, this is non-negotiable for all device classes.
No history of license cancellation : If an applicant's previous medical device license was cancelled or suspended by CDSCO due to non-compliance or violations, they may be ineligible or subject to additional scrutiny.
Device must be new : Only brand-new medical devices can be imported. Refurbished, second-hand, or used medical devices are not eligible for import under the MD-15 license.

Class-Specific Eligibility Notes

Class A (non-sterile, non-measuring) : These do NOT need an MD-15 license. Only voluntary registration is required. Applying for MD-15 for these devices is unnecessary.
Class A (sterile or measuring), Class B : Requires MD-15 and standard QMS documentation. CDSCO review is relatively faster for these classes.
Class C and D : Stricter eligibility. A Clinical Evaluation Report (CER) is typically mandatory. CDSCO may also request a Medical Device Advisory Committee (MDAC) review before granting the license. The overseas manufacturing site inspection is more likely to be triggered for these classes.

Documents Required for MD-15 Medical Device Import License

This is often the most overwhelming part. Here is the complete list in simple terms:

Company and Agent Documents

Cover letter explaining the purpose of your application
Filled application in Form MD-14 (this is the application form for the MD-15 license)
Power of Attorney notarized and apostilled (gives the Indian agent authority to act on your behalf)
Copy of the Indian agent's wholesale license or manufacturing license (Form MD-42)
Constitution details of the Indian authorized agent (proof of the company's legal existence)
GST certificate (for Indian businesses)

Manufacturer and Facility Documents

Copy of the valid manufacturing license from the country of origin
Notarized copy of overseas manufacturing site registration (from your country's regulatory authority)
ISO 13485 certificate notarized (proves the manufacturer follows international quality standards)
Copy of the latest inspection or audit report from a Notified Body or National Regulatory Authority (within last 3 years)
Plant Master File (PMF) detailed information about your manufacturing facility

Product-Specific Documents

Device Master File (DMF) detailed technical information about the device itself
Free Sale Certificate (FSC) notarized copy from the National Regulatory Authority of the country of origin (proves the device is legally sold in its home country)
FSC from any of these countries (if applicable): USA, UK, EU, Canada, Japan, or Australia
Declaration of Conformity notarized (confirms the device meets applicable regulatory standards)
CE Design Certificate (if the device has CE marking)
Full Quality Assurance Certificate or CE type examination certificate
Risk Management Plan
Clinical Evaluation Report (CER) especially required for Class C and D devices
Labels and Instructions for Use (IFU)
Batch Release Certificate
Schedule D(I) Documentation

Note: Additional documents may be required depending on the device class and whether it is a novel device (one with no previous approval anywhere in the world).

Step-by-Step Process to Get Your CDSCO MD-15 License

Step 1 : Determine Your Device Classification

Find out which class (A, B, C, or D) your medical device belongs to. This determines what documents you need and how much the government fee will be. If you are unsure, our team can classify your device for you.

Step 2 : Appoint an Indian Authorized Agent (for foreign manufacturers)

If your company is based outside India, identify and appoint a licensed Indian agent. This agent must have a valid wholesale license (Form MD-42). The agent will file everything on your behalf.

Step 3 : Register on the CDSCO SUGAM Portal

Create a user account on the official CDSCO online portal: SUGAM (cdscoonline.gov.in). This is where all applications are submitted digitally.

Step 4 : Prepare and Compile All Documents

Gather all the documents listed above. Make sure notarizations and apostilles are in place. Incorrect or incomplete documents are the biggest reason for delays and rejections.

Step 5 : Fill and Submit Form MD-14

Log in to the SUGAM portal and fill out Form MD-14 carefully. Upload all supporting documents. Make sure product details, manufacturer details, and agent details are all accurate.

Step 6 : Pay the Government Fee

Pay the applicable government fee online based on your device class (see fee table below). You will receive a payment confirmation and an application reference number.

Step 7 : CDSCO Review and Query Resolution

CDSCO officers will review your application. They may raise queries, questions or requests for additional information. It is very important to respond to these quickly and accurately. Slow or incorrect responses can delay your approval significantly.

Step 8 : Facility Inspection (if required)

CDSCO may inspect your importing firm's facility in India to verify it meets quality and regulatory standards. Be ready for an inspection at any time during the process.

Step 9 : Approval and Grant of MD-15 License

Once CDSCO is satisfied with everything, they will issue your MD-15 medical device license. You are now legally allowed to import and sell the medical devices listed in your license in India.

Total Timeline : Approximately 6 to 9 months from the date of application submission.

Government Fee for MD-15 License

The fee depends on your device class. All fees are in USD as specified in the Medical Devices Rules, 2017 :

Device Type	Site Registration Fee	Fee Per Device
Class A (sterile or measuring) non-IVD	$1,000	$50
Class B non-IVD	$2,000	$1,000
Class A or B IVD (In Vitro Diagnostic)	$1,000	$10
Class C or D non-IVD	$3,000	$1,500
Class C or D IVD	$3,000	$500
Overseas site inspection (if conducted)	$6,000	—

IVD means In Vitro Diagnostic these are devices used to test samples like blood or urine outside the body (e.g., pregnancy test kits, blood sugar meters).

Validity and Renewal of the MD-15 License

How long is the license valid?

The MD-15 license remains valid indefinitely; it does not have a fixed expiry date. However, you must pay a license retention fee every 5 years from the date of issue to keep it active. If you do not pay the retention fee within the required time period, your license will be treated as cancelled automatically.

Renewal and Modifications :

If you want to add new devices to your existing license, or update manufacturer or agent details, you can apply for a modification (variation application) to CDSCO.

MD-15 vs MD-16: What Is the Difference?

Many people get confused between the MD-15 and MD-16 licenses because both allow you to import medical devices into India. However, they are very different in purpose, scope, and conditions. Choosing the wrong one or applying for MD-16 when you actually need MD-15 is a common and costly mistake.
Here is a complete, point-by-point comparison :

Point	MD-15	MD-16
1. Purpose	This is the full, permanent license to import medical devices into India for the purpose of commercial sale and distribution. If you want to run a business selling imported medical devices in India, this is the license you need.	This is a limited, temporary license to import medical devices in small quantities only for non-commercial purposes such as testing, demonstration, training, or clinical investigation. You cannot sell devices imported under an MD-16 license.
2. Application Form	Applied for using Form MD-14. The license is granted in Form MD-15.	Applied for using Form MD-16. The license is granted in Form MD-17.
3. Who Should Apply	Any importer, distributor, Indian Authorized Agent, hospital, or research institution that wants to import medical devices for sale or regular supply in India.	Any entity including companies that do not yet have a full MD-15 license that needs to bring in a small quantity of devices for one of these specific purposes : Testing the device in a laboratory or clinical setting; Demonstrating the device to potential buyers or healthcare professionals; Training hospital staff or users on how to operate the device; Conducting a clinical investigation (clinical trial) of an investigational device
4. Quantity Allowed	No restriction on the quantity of devices you can import as long as they are listed on your license, you can import commercially viable volumes.	Only small quantities are permitted. The exact quantity allowed is specified in the test license itself and is limited to what is reasonably needed for the stated purpose (testing, demo, training, or trial). You cannot import bulk stock under MD-16.
5. Validity Period	Valid indefinitely (no fixed expiry), as long as the license retention fee is paid every 5 years.	Valid for a limited period only typically tied to the duration of the specific activity (e.g., the duration of a clinical trial or demonstration event). Once that activity is complete or the license expires, it cannot be extended for commercial use.
6. Can You Sell Devices Imported Under This License?	Yes. Devices imported under MD-15 can be legally sold and distributed in India.	No. Devices imported under MD-16 are strictly for the stated non-commercial purpose. Selling them is a violation of the license conditions and can result in penalties.
7. Documents Required	Full documentation required Plant Master File, Device Master File, ISO 13485 certificate, Free Sale Certificate, Clinical Evaluation Report (for Class C/D), Power of Attorney, manufacturing license, and more (see full list in the documents section above).	Fewer documents required primarily the purpose of import, quantity needed, device details, and basic manufacturer information. The process is lighter because the scope is limited.
8. Government Fee	Full fee applies based on device class (from $50 to $1,500 per device plus site registration fee of $1,000 to $3,000).	Lower fee compared to MD-15, as it is a test/temporary license with limited scope.
9. Can MD-16 Lead to MD-15?	Yes MD-16 is often used as a stepping stone. A foreign manufacturer may first import a small quantity under MD-16 to conduct a clinical investigation in India. The data gathered from that investigation can then be submitted as part of the full MD-15 license application. However, MD-16 does not automatically convert to MD-15. A separate, full MD-15 application must be filed.	Yes MD-16 is often used as a stepping stone. A foreign manufacturer may first import a small quantity under MD-16 to conduct a clinical investigation in India. The data gathered from that investigation can then be submitted as part of the full MD-15 license application. However, MD-16 does not automatically convert to MD-15. A separate, full MD-15 application must be filed.

What Happens After You Get the MD-15 License?

Getting the license is not the end of the journey. Here is what you need to keep doing :

Pay the retention fee every 5 years to keep your license active
Report adverse events if your device causes or contributes to a patient's injury or death, you must report it to CDSCO (post-market surveillance)
Keep your labels and documentation updated as per CDSCO requirements
Apply for amendments if you change your manufacturer, agent, or add new products

Special Cases : When Do You Need Additional Permissions?

Test License to Import (Form MD-16 / MD-17)

If you want to import a small quantity of devices just for testing, demonstration, clinical investigation, or training and do not yet have a full MD-15 license you can apply for a test import license using Form MD-16. The license is granted in Form MD-17.

Import for Personal Use (Form MD-20 / MD-21)

If an individual wants to import a medical device in a small quantity for their own personal use (not for sale), they can apply using Form MD-20. Permission is granted in Form MD-21.

Novel Devices (Form MD-26 / MD-27)

If your device does not have a "predicate device" in India meaning no similar device has been approved before you need to apply for special approval using Form MD-26. The approval is granted in Form MD-27. This process may also require clinical investigations.

Clinical Investigation Permission (Form MD-22 / MD-23)

If you need to conduct clinical trials of an investigational device in India, you must get permission from CDSCO by submitting Form MD-22.

Common Mistakes to Avoid When Applying for the MD-15 License

Many applications get delayed or rejected not because the device is ineligible, but because of avoidable errors in the process. Here are the most common mistakes applicants make and how to avoid them :

Submitting an incomplete Form MD-14 -

Leaving fields blank or providing partial information in Form MD-14 is one of the top reasons for rejection
Every field, product details, manufacturer details, Indian agent details, device classification, must be filled in accurately and completely
Even a minor mismatch (e.g., the manufacturer name on the form differs from the name on the ISO certificate) can trigger a query or rejection

Using documents that are not properly notarized or apostilled -

Many documents must be notarized in the country of origin AND apostilled (an international certification confirming the notary's authority)
Common mistake: submitting notarized documents without apostille, or apostilled documents that have already expired
The Power of Attorney, Free Sale Certificate, ISO 13485 certificate, and manufacturing license all typically require notarization and/or apostille

Applying without a valid wholesale license (Form MD-42)

The Indian importer or agent MUST hold Form MD-42 (wholesale license for medical devices) before applying for MD-15
A common mistake is trying to apply for both simultaneously, you must obtain MD-42 first
Submitting an MD-15 application without a valid MD-42 will result in outright rejection

Incorrect device classification

Filing under the wrong class (e.g., treating a Class C device as Class B) leads to insufficient documentation and a guaranteed rejection
Some applicants also incorrectly assume their device does not need an MD-15 license when it actually does (e.g., a Class A sterile device)
Always verify classification against the CDSCO notified device list before applying

Submitting outdated documents

The inspection or audit report from a Notified Body or NRA must be from within the last 3 years, older reports are rejected
ISO 13485 certificates also have validity periods submit only currently valid certificates
Free Sale Certificates must be current and valid at the time of submission, not expired

Not responding to CDSCO queries on time

After submission, CDSCO may raise written queries asking for clarification or additional documents
A very common mistake is responding late, responding incompletely, or not responding at all
Unanswered queries can lead to the application being treated as abandoned
Always monitor your application on the SUGAM portal and respond within the timeframe given

Mismatch between documents and application data

If the device name on the Free Sale Certificate differs slightly from the name entered in Form MD-14, CDSCO will flag it
If the manufacturer's address on the ISO certificate differs from what is in the Plant Master File, that triggers a query
All documents must be internally consistent names, addresses, device model numbers, and specifications must match exactly across all submissions

Submitting the Free Sale Certificate without the correct country reference

CDSCO gives preference to FSCs from reference countries: USA, UK, EU, Canada, Japan, or Australia
Submitting only an FSC from a non-reference country can slow down the review significantly
If your device is approved in a reference country, always include that FSC in your application

Overlooking the Plant Master File (PMF) and Device Master File (DMF)

Many applicants prepare these files incompletely, missing sections on manufacturing processes, quality controls, or facility details
CDSCO reviewers rely heavily on these files to assess manufacturing compliance
A poorly prepared PMF or DMF almost always results in multiple back-and-forth queries

Not checking if the device is notified under CDSCO

CDSCO only regulates "notified" medical devices those officially listed under the Medical Devices Rules
If your device has not been notified yet, a standard MD-15 application will not work, as separate process is needed
Always confirm your device's notification status before starting the application

Assuming approval is automatic or fast after submission

Many first-time applicants expect approval within a few weeks of submitting
The realistic timeline is 6 to 9 months, and delays are common whenever queries arise
Not planning for this timeline can disrupt your product launch, factor it into your business schedule

Poor communication between foreign manufacturer and Indian Authorized Agent

If the foreign manufacturer and the Indian agent are not in regular contact, important queries from CDSCO can be missed or answered incorrectly
Establish a clear communication protocol with your IAA before starting the application

Complete Timeline Summary

Stage	Activity	Estimated Time
Stage 1	Pre-application preparation	4 to 8 weeks
Stage 2	Portal registration and submission	3 to 7 days
Stage 3	Initial CDSCO scrutiny	4 to 8 weeks
Stage 4	Technical review and query resolution	2 to 4 months
Stage 5	MDAC review (if applicable)	4 to 12 weeks
Stage 6	Facility inspection (if triggered)	4 to 12 weeks
Stage 7	Final approval and license grant	2 to 4 weeks
Total (typical)	End-to-end for a well-prepared application	6 to 9 months
Total (with complications)	If multiple query rounds or overseas inspection	12 to 18 months

What Can Make the Timeline Longer?

Incomplete documents at submission triggers multiple query rounds, each adding weeks
Slow query responses CDSCO may close or deprioritize your application if queries go unanswered
Overseas manufacturing site inspection adds travel scheduling time and potential CAPA resolution time
MDAC review requirement depends on meeting schedules that are outside your control
Public holidays and CDSCO workload CDSCO processes thousands of applications; peak periods can slow individual reviews
Novel or first-of-its-kind device requires more scrutiny and may need clinical investigation data from India

What Can Make the Timeline Shorter?

Submitting a complete, well-organized application on Day 1 no queries means no delays
Using an experienced regulatory consultant they know exactly what CDSCO looks for and prevent avoidable gaps
Device already approved in USA, UK, EU, Canada, Japan, or Australia CDSCO gives faster processing to devices with reference country approvals
Responding to queries within 7 to 14 days keeps your file active and progressing
Pre-submission review having an expert review your documents before filing catches problems before CDSCO does.

Why Choose PSR Compliance for Your MD-15 License?

Device classification - we identify the correct class for your device
Document preparation - we help you compile and verify every required document
SUGAM portal filing - we handle the complete online application process
Query management - we respond to all CDSCO queries on your behalf, promptly and correctly
Post-license support - we assist with retention fee reminders, amendments, and compliance requirements
Authorized Agent services - we can act as your Indian Authorized Agent if you are a foreign manufacturer

Getting your medical device into the Indian market is a big opportunity. Let us make sure the regulatory process does not slow you down.

Frequently Asked Questions

No. Foreign manufacturers must appoint a licensed Indian Authorized Agent (IAA) who will apply on their behalf through the CDSCO SUGAM portal.

Not always. It is typically required for Class C and D devices, and for novel devices with no predicate in India. CDSCO may ask for it during the review process.

The standard timeline is 6 to 9 months after submitting a complete application. Delays usually happen due to incomplete documents or slow responses to CDSCO queries.

Yes. You can apply for a modification to your existing license to include additional devices.

CDSCO may reject it or ask you to correct it. This causes significant delays. It is best to get expert help before submitting.

No. As per CDSCO regulations, only new medical devices with valid regulatory approvals can be imported into India.

No. These devices only need a CDSCO medical device registration (voluntary registration), not a full import license.

SUGAM (cdscoonline.gov.in) is the official online portal of CDSCO where all medical device applications including the MD-15 license application are submitted.

CDSCO MD-15 License : How to Get Your Medical Device Import License in India (2026 Complete Guide)

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