MD-14 MD-15 Medical Device Import License Consultant | The 2026 Guide for Importers
MD-14 MD-15 Medical Device Import License Consultant | The 2026 Guide for Importers - NKB Regovanta
Table of Contents
17 sections in this regulatory guidance
Every medical device sold in India from an overseas factory needs one document before it clears customs: the Form MD-15 import licence. Getting it is where most importers stall. An MD-14 MD-15 medical device import license consultant prepares your Form MD-14 application, builds the technical dossier the regulator expects, and answers the queries that would otherwise add months to your launch.
The volumes are large. India still imports roughly 70% of its medical devices and spent more than USD 25 billion on device imports between FY2020-21 and FY2024-25, according to figures placed before the Rajya Sabha. Each of those shipments needed a valid CDSCO import licence.
In this guide, you will learn what MD-14 and MD-15 mean, which documents CDSCO checks, what the government fees are, how long approval takes, and how to tell whether a consultant will speed up your file or slow it down.
What Does an MD-14 MD-15 Medical Device Import License Consultant Do?
An MD-14 MD-15 medical device import license consultant is a regulatory specialist who manages your import licence application with the Central Drugs Standard Control Organisation (CDSCO) from first review to final grant. The role mixes technical writing, regulatory strategy and plain project management.
The consultant starts by confirming your medical device classification under the Medical Devices Rules 2017. They check whether your product has a predicate device already approved in India, because that decides which form you file. Then they collect evidence from the overseas manufacturer and turn it into a Device Master File and a Plant Master File.
Submission is not the finish line. CDSCO reviewers often send queries, and the consultant replies with evidence rather than opinion. The file keeps moving until the Form MD-15 licence appears in your portal account.
If you are still mapping the wider approval landscape, our explainer on how to register a medical device with CDSCO in India sets the context.
MD-14 vs MD-15: Understanding the Two Forms
People talk about "the MD-14 MD-15 licence" as if it were one document. It is two. Form MD-14 is the application you submit. Form MD-15 is the licence CDSCO grants once it approves that application.
Both forms come from the Medical Devices Rules, 2017, which set out who may import, what evidence they must show and what they pay. The rules also create separate import routes for special cases, so picking the right form comes first.
Table 1: CDSCO import forms at a glance
| Form | What it is | When it applies |
|---|---|---|
MD-14 | Application for an import licence | Devices with a predicate approved in India, Class A to D |
MD-15 | Import licence granted by CDSCO | Issued after the MD-14 application is approved |
MD-26 / MD-27 | Application and permission to import a device without a predicate | New or novel devices entering India for the first time |
MD-16 / MD-17 | Test licence for small quantities | Testing, evaluation, demonstration or training |
MD-20 / MD-21 | Permission to import for personal use | An individual patient's own treatment |
If your device has no predicate in India, MD-14 is the wrong starting point. You will need import permission under Forms MD-26 and MD-27 first. It also helps to read up on the 2026 Rule 63 amendment (G.S.R. 744(E)) before you plan the route. Samples for evaluation go through a test licence under Forms MD-16 and MD-17, and a patient bringing in their own device uses Forms MD-20 and MD-21.
Who Needs an MD-15 Import Licence in 2026?
Any business that imports a regulated medical device for sale or distribution in India needs an import licence. That includes distributors, hospital supply partners, online sellers of devices and overseas brands entering India for the first time.
The market justifies the paperwork. IBEF valued the Indian medical devices market at about USD 11 billion in 2022 and projects USD 50 billion by 2030, a compound annual growth rate of around 16%.
Foreign Manufacturers and the Indian Authorised Agent
A foreign manufacturer cannot file Form MD-14 on its own. It must appoint an Indian Authorised Agent through a Power of Attorney, authenticated in the country of origin. The agent holds a wholesale licence or an MD-42 registration certificate, files the application and carries legal responsibility inside India.
The agent also needs an Importer Exporter Code from DGFT. If you do not have one yet, sort out IEC registration early. Customs asks for it on the very first shipment.
Class A Non-Sterile, Non-Measuring Devices
Low-risk Class A devices that are neither sterile nor used for measurement follow a lighter path. They do not need an MD-15 licence, but the importer must still register them on the CDSCO online portal. Our page on Class A import registration under GSR 777(E) walks through that route.
Why Hire an MD-14 MD-15 Medical Device Import License Consultant?
Nothing stops you from filing Form MD-14 yourself. The portal is public and CDSCO publishes an official checklist for Form MD-15. So why pay an MD-14 MD-15 medical device import license consultant?
The honest answer is time. The rules give CDSCO up to nine months to decide, and every query round adds weeks on top. Most delays come from avoidable gaps: an expired Free Sale Certificate, a Device Master File without a risk analysis, or a Power of Attorney that was never apostilled. An experienced consultant spots these before the reviewer does.
Table 2: Filing yourself vs working with a consultant
| Factor | Filing yourself | With a consultant |
|---|---|---|
Classification | Read from the notified lists, often with guesswork | Checked against CDSCO notifications and past approvals |
Dossier | EU or FDA file uploaded as it is | Restructured into the Indian Device and Plant Master File format |
Queries | Answered after they arrive, sometimes twice | Anticipated and covered in the original dossier |
Internal effort | Your team learns the rules on a live file | Your team supplies data; the consultant drafts |
Risk of rejection | Higher on a first attempt | Lower, because gaps close before submission |
For a broader view of what a specialist firm covers beyond import licensing, see our guide to working with a medical device regulatory consultant in India.
Documents Needed for an MD-14 Application
CDSCO reviewers work from the MD-15 checklist, so your file should follow it line by line. Here is the core set an MD-14 MD-15 medical device import license consultant will ask your manufacturer to supply.
Table 3: Core document set for Form MD-14
| Document | What it proves |
|---|---|
Covering letter and Form MD-14 | The formal request, device list and manufacturing sites |
Fee challan | Government fee paid under the Second Schedule |
Power of Attorney and agent undertaking | The manufacturer has authorised the Indian agent |
Agent's MD-42 or wholesale licence | The agent may legally stock and sell devices |
Free Sale Certificate | The device is legally sold in its home country and, where needed, in the USA, UK, EU, Canada, Japan or Australia |
ISO 13485 certification and QA certificates | The factory runs a controlled quality system |
Declaration of Conformity | The manufacturer confirms compliance with essential principles |
Plant Master File | Site layout, processes, equipment and controls |
Device Master File | Design, risk analysis, verification, biocompatibility, sterilisation, software validation, clinical evidence and labels |
Latest audit or inspection report | An independent look at the site, ideally within the last three years |
The Device Master File carries the most weight. For implants and skin-contact products, reviewers read ISO 10993 biological evaluation data closely. Keep the manufacturer's ISO 13485 certificate current throughout review, because an expired certificate is one of the quickest ways to earn a query.
Need a certificate from an Indian authority for your own exports? That is a separate service; see our Free Sale Certificate support.
Step-by-Step Filing Process With an MD-14 MD-15 Medical Device Import License Consultant
Most projects move through six stages. The order matters, because each stage feeds the next.
Step 1: Classify the Device and Confirm the Route
The consultant checks CDSCO's risk-based lists and confirms whether the device sits in Class A, B, C or D. They also confirm whether a predicate exists in India. Software, accessories and combination products often sit on the boundary; our borderline device classification strategy article covers those cases.
Step 2: Appoint the Indian Authorised Agent
The manufacturer signs a Power of Attorney naming the agent. The agent puts its MD-42 certificate or wholesale licence in place and opens an account on the CDSCO medical devices portal.
Step 3: Run a Gap Analysis
The consultant compares the manufacturer's existing technical file with Indian requirements. An EU MDR or US FDA file covers much of the ground. Indian labelling, the Plant Master File and a few declarations usually need fresh work.
Step 4: Build the Device and Plant Master Files
Drafting comes next. Raw test reports, risk files and clinical data become the structured dossier CDSCO expects. A sensible device grouping lets one application cover a full product family instead of one model at a time.
Step 5: Submit Form MD-14 and Pay the Fees
The agent uploads the dossier, pays the government fee online and submits. The licensing authority can also inspect the overseas manufacturing site if it wants to see the process first-hand.
Step 6: Answer Queries and Receive the MD-15
Reviewers raise queries through the portal with a response deadline. The consultant drafts replies backed by data, not promises. Once CDSCO is satisfied, it issues the MD-15 licence online, and the importer can start clearing shipments.
MD-15 Import Licence Fees, Timeline and Validity
The Second Schedule of the Medical Devices Rules 2017 sets government fees in US dollars. You pay one fee for each overseas manufacturing site and another for each distinct device.
Table 4: Government fees for an import licence (Form MD-14)
| Device class | Fee per site | Fee per distinct device |
|---|---|---|
Class A | USD 1,000 | USD 50 |
Class B | USD 2,000 | USD 1,000 |
Class C | USD 3,000 | USD 1,500 |
Class D | USD 3,000 | USD 1,500 |
These figures cover government fees only. Consultant fees come on top and depend on the device class, the number of products and how complete the manufacturer's files already are. Check the current fee notice on the portal before paying, since CDSCO revises its schedules from time to time.
On timing, the rules allow CDSCO up to nine months to grant or refuse an application. A clean file often moves faster. A file that bounces through several query rounds can run longer.
The MD-15 has no fixed expiry date. It stays valid as long as you pay the retention fee every five years from the date of issue. Miss that payment and the licence can lapse, which stops your imports until you put it right.
How to Choose the Right MD-14 MD-15 Medical Device Import License Consultant
Plenty of firms advertise CDSCO services. These checks help you separate specialists from form-fillers.
Ask how many MD-15 licences the firm has secured in your device class over the last two years.
Check that the team can read test reports, risk files and clinical data, not just upload them.
Confirm the firm can act as your Indian Authorised Agent or introduce you to a reliable one.
Request a written gap analysis before you sign a full engagement.
Find out who writes the query responses and how fast they usually turn them around.
Look for experience with EU MDR, US FDA or other markets, because that makes reusing your existing dossier far easier.
The right MD-14 MD-15 medical device import license consultant will also tell you plainly when your file is not ready, rather than submitting it and hoping. That candour saves more time than any shortcut.
Common Mistakes That Delay Approval
Most long delays trace back to a short list of errors, and nearly all of them are preventable.
Wrong classification comes first. File a Class C device as Class B and CDSCO sends it back, so you restart work you thought was finished.
Weak Free Sale Certificates come next. A certificate that does not list the exact model, or one that has expired, draws an immediate query.
Labels cause trouble too. Indian labels must show the import licence number and the importer's name and address, so an EU label copied across will not pass.
Finally, many importers forget about post-approval changes. Adding a new model or a new manufacturing site needs CDSCO approval before you ship. Our summary of CDSCO medical device registration guidelines lists the rules that trip people up most often.
Staying Compliant After You Receive the Licence
The licence is half the job. The rules expect importers to stay compliant for as long as they sell in India.
That means paying the retention fee on time, keeping distribution records, reporting adverse events, and getting CDSCO approval before major changes to the device, the site or the labelling. Minor changes still need a formal notification. A working quality system makes all of this easier; our notes on QMS documentation for ISO 13485 compliance show what good records look like.
If you may manufacture locally one day, compare the import route with a CDSCO medical device manufacturing licence. Some companies start with imports and move to Indian production once volumes justify a plant.
What Importers Discuss About MD-15 Licensing on Reddit
Practical experience rarely shows up in official guidance. Regulatory professionals and first-time importers compare notes in communities such as r/regulatoryaffairs, r/MedicalDevices, r/StartUpIndia and r/IndiaBusiness.
A Reddit search for "CDSCO import licence" pulls up posts and comment threads on review times, agent selection and query handling. Use these conversations to ask practical questions, such as how long reviews are taking right now or which queries are common for your device type. Then confirm anything important against the rules themselves or with a qualified MD-14 MD-15 medical device import license consultant.
Frequently Asked Questions About MD-14 MD-15 Medical Device Import License Consultants
What is an MD-14 MD-15 medical device import license consultant?
An MD-14 MD-15 medical device import license consultant is a regulatory professional who prepares and manages an application for a CDSCO import licence. The consultant classifies the device, coordinates the Indian Authorised Agent, builds the Device and Plant Master Files, files Form MD-14 on the portal and answers reviewer queries until CDSCO grants the MD-15 licence. Importers use one to cut rework and avoid long query cycles.
How long does CDSCO take to approve an import licence?
The Medical Devices Rules give CDSCO up to nine months to decide on a Form MD-14 application. A complete, well-organised dossier often moves faster, while repeated queries push the timeline out. An experienced MD-14 MD-15 consultant shortens the process mainly by closing document gaps before submission, which reduces the number of query rounds. Our medical device import licence consultant guide covers timelines in more depth.
How much does an MD-15 licence cost?
Government fees depend on class. For each overseas site, Class A costs USD 1,000, Class B USD 2,000, and Classes C and D USD 3,000. Each distinct device adds USD 50 for Class A, USD 1,000 for Class B and USD 1,500 for Classes C and D. An MD-14 MD-15 medical device import license consultant charges professional fees on top, based on scope and dossier readiness.
What is the difference between MD-15 and MD-42?
Form MD-15 is the import licence that lets a named importer bring specific devices from specific overseas sites into India. The MD-42 registration certificate lets a business stock, sell and distribute medical devices within India. The Indian Authorised Agent usually needs MD-42 or a wholesale licence before an MD-15 import licence consultant can file Form MD-14 in its name.
Can a foreign manufacturer apply directly?
No. A foreign manufacturer must appoint an Indian Authorised Agent, who files Form MD-14 under a Power of Attorney and holds the MD-15 licence in India. Many overseas brands ask their MD-14 MD-15 medical device import license consultant to recommend or act as that agent. Our page on regulatory solutions for importers in India explains the options.
Do I need a consultant if I already have CE marking or FDA clearance?
CE marking or FDA clearance helps a great deal, because CDSCO accepts free sale evidence from those markets and much of the technical file can be reused. Still, Indian requirements differ on format, labelling, the Plant Master File and agent documents. An import licence consultant converts the existing dossier for CDSCO, so you avoid a query cycle that repeats work you have already done.
Who issues the import licence for medical devices in India?
The Central Licensing Authority at CDSCO issues the import licence in Form MD-15. The Indian Authorised Agent applies through Form MD-14 on the CDSCO medical devices portal, and the licence is granted online once reviewers approve the dossier.
What documents does CDSCO ask for?
CDSCO asks for Form MD-14, a fee challan, a Power of Attorney, the agent's MD-42 or wholesale licence, a Free Sale Certificate, ISO 13485 and QA certificates, a Declaration of Conformity, a Plant Master File and a Device Master File covering design, risk and clinical evidence.
How long is the licence valid?
An MD-15 import licence has no fixed expiry. It stays valid as long as the holder pays the retention fee every five years from the date of issue and CDSCO does not suspend or cancel it. Missing the retention fee can cause the licence to lapse.
Do Class A devices need an import licence?
Class A devices that are sterile or have a measuring function need an MD-15 import licence. Class A devices that are non-sterile and non-measuring are exempt from licensing, but the importer must still register them on the CDSCO online portal before import.
A well-prepared file is still the fastest way through CDSCO. Working with an MD-14 MD-15 medical device import license consultant means your classification, dossier and agent arrangements are right before a reviewer ever opens the application. NKB Regovanta handles import licences for predicate devices under Forms MD-14 and MD-15, from gap analysis to the final licence, and supports companies across medical device licensing and regulatory approvals in India. If you are weighing an MD-14 MD-15 medical device import license consultant for your next launch, start with a gap analysis of your current technical file and see exactly what stands between you and your MD-15. Talk to the NKB Regovanta India team and plan your entry into one of the world's fastest-growing device markets.
NKB Regulatory Experts
Verified Regulatory ExpertM.Pharm, RAC (Global Regulatory Affairs Certified)
Senior Regulatory Affairs & Quality Assurance Specialists at NKB Regovanta Solutions Pvt. Ltd., guiding MedTech manufacturers worldwide across CDSCO, US FDA, EU MDR, and ISO 13485 compliance.
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