How to Get Medical Device Import License in India | The Complete 2026 Guide
How to Get Medical Device Import License in India | The Complete 2026 Guide - NKB Regovanta
Table of Contents
17 sections in this regulatory guidance
Say you have a buyer ready for a line of imported patient monitors. The hospital wants delivery in six months, and your first shipment is booked. Before any of that happens, you need to know how to get medical device import license in India, because customs will not release regulated devices without it and no hospital can legally buy them.
The Central Drugs Standard Control Organisation (CDSCO) issues this permission under the Medical Devices Rules 2017. Demand for it is huge. The U.S. International Trade Administration puts India's device market at about $11 billion and reports that the country imports close to 80% of its medical devices. Every one of those products needs a valid CDSCO import license or registration.
This guide covers how to get medical device import license in India from the first classification check to the day your license arrives. You will see who can apply, what the government charges, which documents reviewers expect, how long approval takes, and the mistakes that stall most files.
What Is a Medical Device Import License in India?
A medical device import license is the permission CDSCO grants an Indian company to bring a specific device, made at a specific overseas site, into the country for sale or distribution. You apply on Form MD-14. CDSCO grants the license on Form MD-15.
The license ties together three things: the product, the foreign manufacturer and the manufacturing site. Change any one of them and you usually need an endorsement or a fresh application. Importers who add new models every year end up managing the license like a living document rather than a one-time certificate.
CDSCO publishes the rules, forms and circulars on its official imports and registration page. If you are new to the wider system, our explainer on how to register a medical device with CDSCO in India sets out the basics first.
Who Can Apply for an MD-15 License?
The applicant must be an Indian entity. That can be the manufacturer's own Indian subsidiary or an authorised Indian agent. A foreign company with no Indian presence cannot file on its own.
The agent also needs permission to sell or distribute devices. That means a manufacturing licence, a wholesale licence on Forms 20B/21B, or a registration certificate in Form MD-42, which became mandatory for sellers without older licences in September 2022.
Choose the agent with care. CDSCO holds it responsible for complaints, recalls and adverse event reports, so it effectively carries your brand's legal risk in India.
Why an Import License Matters for Your Business in 2026
You cannot sort out the license after the goods ship. Customs officers check for a valid MD-15 or Class A registration before they release medical devices. Shipments without one sit in the warehouse while storage charges pile up, and some end up re-exported.
Tenders are the second reason. Government hospitals and large private chains ask for the license copy at the bid stage. No license means no bid, whatever your price.
Timing is the third. The rules give CDSCO up to nine months to decide an application, and incomplete files take longer. Companies that file early launch on schedule. Companies that file late watch competitors take the first year of contracts.
Table 1: Three situations importers commonly face
| Situation | At customs | Can you sell to hospitals? | Main risk |
|---|---|---|---|
Valid MD-15 license | Released after routine checks | Yes, including tenders | Low, if labels match the license |
Class A registration (non-sterile, non-measuring) | Released with registration proof | Yes | Low, but only for truly exempt devices |
No license, or device missing from license | Detained or sent back | No | Penalties under the Drugs and Cosmetics Act, 1940, and lost stock |
Confirm your device's risk class before you open any form. India's medical device classification system has four classes: Class A (low risk), Class B (low to moderate), Class C (moderate to high) and Class D (high risk). A tongue depressor sits in Class A. A heart valve sits in Class D.
The class drives almost everything that follows: the fees, the depth of the technical file and how closely reviewers read it. CDSCO publishes product-wise classification lists, so check whether your device appears there before you rely on the manufacturer's EU or US class. The Indian class does not always match.
Software, accessories and drug-device combinations need extra care. Our guide to borderline medical device classification strategy explains how to support a class decision with evidence.
Class A Non-Sterile, Non-Measuring Devices: The Exception
Low-risk Class A devices that are non-sterile and do not measure anything follow a lighter route. Instead of a full MD-15 license, the importer registers the product on the CDSCO online portal under notification GSR 777(E). Examination gloves, crutches and stethoscopes are typical examples.
The registration still needs a free sale certificate from the country of origin. It costs less and moves faster, but it only works if the device meets every condition. A sterile or measuring Class A device goes back on the MD-14 route. See our page on Class A import registration under GSR 777(E), and our note on the India MDR 2026 Rule 63 amendment for the latest Class A quality system changes.
How to Get Medical Device Import License in India: Step-by-Step Process
The six steps below show how to get medical device import license in India in the order that works for most importers. Each one builds on the last, so jumping ahead usually costs time later.
Step 1: Confirm the Device Class and Regulatory Status
Gather the device's intended use, its class in other markets and its approvals from reference countries such as the EU, US, UK, Canada, Australia or Japan. Map it against the Indian classification list.
Next, check whether a similar device already sells in India. A device with a predicate follows the standard MD-14 route. A truly new device may need a clinical investigation or a separate permission first, which changes your whole timeline.
Step 2: Appoint an Authorised Indian Agent
The foreign manufacturer signs a Power of Attorney that names the Indian agent and lists every device it covers. Manufacturers in Hague Convention countries apostille the document. Others notarise it and get it legalised at the Indian embassy.
Make the device names on the Power of Attorney match your application word for word. A missing hyphen or a different model code is one of the most common triggers for a CDSCO query.
Step 3: Put Your Business Registrations in Place
The Indian agent needs an Importer Exporter Code (IEC) from the Directorate General of Foreign Trade, GST registration and the sale licence described earlier. If you lack an IEC, our IEC and AD code registration team can arrange it alongside your CDSCO file.
Then register the company on CDSCO's online medical device portal, which many importers still call the SUGAM portal, and wait for the login to be approved before you upload anything.
Step 4: Build the Device Master File and Plant Master File
These two files carry your application. The Device Master File (DMF) describes the product: design, materials, specifications, manufacturing, risk management, verification and validation, biocompatibility, sterilisation, shelf life, labels and clinical evidence.
The Plant Master File (PMF) describes the factory: layout, equipment, quality system, staff and environmental controls. Manufacturers often adapt their EU technical file or US 510(k), but a straight copy rarely fits the Indian format. Our article on ISO 13485 QMS documentation shows what quality evidence reviewers look for.
Step 5: File Form MD-14 on the CDSCO Online Portal
Complete Form MD-14 online, upload the DMF, PMF and supporting documents, and pay the government fee through the portal. One application can cover several devices from the same manufacturer and site, so group products with thought. Grouping affects both the fee and the review.
Open every PDF before you upload it. Unsigned pages, missing apostilles and expired certificates are easy to spot and slow to fix once the file is in the queue.
Step 6: Answer CDSCO Queries and Receive Your MD-15
Reviewers often raise queries through the portal. Answer every point completely in a single reply, since partial answers restart the wait. For higher-risk devices, CDSCO may also inspect the overseas factory.
Once the reviewer is satisfied, CDSCO issues the MD-15 license, which you download from the portal. Check the device names, models and site address on it the same day. Correcting an error now is far easier than after the first shipment lands.
Documents Required for a Medical Device Import License in India
Much of how to get medical device import license in India comes down to paperwork. Your document set decides how fast the file moves. Table 2 lists what CDSCO usually expects with Form MD-14. Exact needs vary by class and device type, so use it as a working checklist rather than a legal list.
Table 2: Core documents for an MD-14 application
| Document | What it proves | Practical tip |
|---|---|---|
Form MD-14 and covering letter | Who is applying and for which devices | Keep device names identical across all papers |
Power of Attorney (apostilled or legalised) | The agent's authority from the manufacturer | List every model and variant |
Free sale certificate | The device sells legally in its home country | Get it from the national regulator where possible |
ISO 13485 certificate | The manufacturer runs a certified quality system | Check the expiry date and the scope wording |
CE, US FDA or other approvals | Approval in a recognised reference market | Upload the latest certificate version |
Device Master File | Design, safety and performance of the device | Follow the Indian DMF structure |
Plant Master File | The manufacturing site and its controls | Describe the exact site named on the application |
Agent's wholesale licence or MD-42 | The agent may legally sell devices | Keep it valid throughout the review |
Labels and instructions for use | What Indian users will see | Leave space for the import license number |
Test reports and biocompatibility data | Safety evidence | Link each report to specific models |
Biocompatibility is where many files fall short. Our guide to ISO 10993 biological evaluation explains the evidence reviewers expect, and our free sale certificate service helps when the home-country document is hard to obtain.
Medical Device Import License Fees in India
CDSCO charges import license fees in US dollars and charges them on two levels: once for each overseas manufacturing site and again for each distinct device. Table 3 shows the schedule from the CDSCO fee table.
Table 3: Government fees for an import license (Form MD-14)
| Device class | Fee per site | Fee per distinct device |
|---|---|---|
Class A (non-IVD) | $1,000 | $50 |
Class B (non-IVD) | $2,000 | $1,000 |
Class C or D (non-IVD) | $3,000 | $1,500 |
Class A or B (IVD) | $1,000 | $10 |
Class C or D (IVD) | $3,000 | $500 |
Here is a worked example. An importer bringing five distinct Class C catheters from one German factory pays $3,000 for the site plus 5 × $1,500 for the devices, or $10,500 in government fees.
Consultant fees, apostille charges, translations and any testing come on top. CDSCO revises fee notifications from time to time, so confirm the amount on the portal on the day you pay.
How Long Does It Take to Get a Medical Device Import License in India?
The Medical Devices Rules allow CDSCO up to nine months from the date of application to decide. A complete Class A or B file often clears sooner. Class C and D files with several rounds of queries can run close to that limit or past it.
Three factors control your timeline. File quality comes first: a clean DMF with consistent device names avoids most queries. Response speed comes second, because every week you take to answer adds a week to approval. Inspection is the third. If CDSCO decides to audit the overseas plant, scheduling alone can add months.
If you are working out how to get medical device import license in India before a tender, plan backwards from your launch date. If a hospital tender opens next March, your file should reach CDSCO nine to twelve months before that, not in December.
Validity, Retention Fee and Duties After Approval
An MD-15 license has no fixed expiry date. It stays valid as long as you pay the retention fee every five years from the date of issue and CDSCO does not suspend or cancel it. If you miss the due date, the rules allow a 90-day grace period with a late charge. Miss that too and the license lapses, which halts imports.
The license also brings ongoing duties. You must report serious adverse events, handle complaints, support recalls and tell CDSCO about changes. Major changes, such as a new material, a new site or a new intended use, need approval before you import the changed product.
Labelling Rules Once You Hold the License
Every imported device must show the import license number, the importer's name and address, and the manufacturer's details on its label. Packaged goods must also follow the Legal Metrology (Packaged Commodities) Rules, which cover declarations such as MRP and net quantity.
Many importers apply an India-specific sticker at a bonded warehouse. Plan the artwork early, because your label files form part of the MD-14 submission.
Other CDSCO Import Permissions You Might Need
The MD-15 license covers commercial import of devices that already have a predicate. Other situations use different forms, so check which one fits before you decide how to get medical device import license in India for your product.
Samples for testing, evaluation, demonstration or training need a test licence on Forms MD-16 and MD-17. A device for one patient's personal use goes through Forms MD-20 and MD-21. New IVDs without a predicate need import permission on Forms MD-26 and MD-27.
Wireless devices that use Bluetooth or Wi-Fi also need WPC approval from the Department of Telecommunications. If you later plan to make devices locally, the CDSCO manufacturing license follows a separate track.
Common Mistakes When You Apply for a Medical Device Import License in India
Most people who ask how to get medical device import license in India are really asking how to avoid a rejection. Most delays come from a short list of avoidable errors. The first is inconsistency: the device name reads one way on the Power of Attorney, another on the free sale certificate and a third on the label.
The second is out-of-date paperwork. An ISO 13485 certificate that expires during review, or a free sale certificate older than CDSCO accepts, triggers an immediate query.
The third is a wrong class. Importers who copy the EU class without checking the Indian list often pay the wrong fee and file the wrong depth of evidence. The fourth is a slow reply to queries, which quietly adds months.
Finally, some importers forget the agent's own licence. If the MD-42 or wholesale licence lapses mid-review, the application stalls. Our CDSCO registration guidelines cover these checks in more detail.
How to Choose the Right Partner for Your Medical Device Import License
A good regulatory partner shortens the path. Use these questions when you compare firms:
Ask how many MD-15 licenses the firm has secured for your device class in the last two years.
Check whether it can act as your authorised Indian agent or can name the agent it works with.
Confirm that it rewrites your DMF and PMF to the Indian format instead of uploading EU or US files as they are.
Ask how it tracks CDSCO queries and what reply time it commits to.
Make sure it covers post-approval work such as retention fees, endorsements and adverse event reports.
Get a written quote that separates government fees from professional fees.
NKB Regovanta runs the complete MD-14 and MD-15 import license service, from classification to post-approval support. You can also read why importers hire a medical device import license consultant in India or a dedicated CDSCO import license consultant.
Where Importers Discuss CDSCO Licensing Online
First-hand accounts can fill gaps that official guidance leaves open, such as how long a query round really took or what an agent charged. Regulatory professionals trade notes in r/regulatoryaffairs and r/MedicalDevices. Indian founders ask business and import questions in r/IndiaBusiness and r/indianstartups.
A direct Reddit search for CDSCO import license pulls up posts and comment threads across all of these communities. Treat what you read as a starting point. Rules change, and a comment from three years ago may describe a step CDSCO has since updated. Cross-check anything important against the official CDSCO FAQ on the Medical Devices Rules.
Frequently Asked Questions About Medical Device Import License in India
Who can apply for a medical device import license in India?
Only an Indian entity can apply. The applicant is either the foreign manufacturer's Indian subsidiary or an authorised Indian agent holding a Power of Attorney from the manufacturer. The agent must also hold a manufacturing licence, a wholesale licence on Forms 20B/21B, or an MD-42 registration certificate. Anyone researching how to get medical device import license in India should settle the agent question first, because every later document names that agent and CDSCO holds it legally responsible for the product in the Indian market.
How much does a medical device import license in India cost?
Government fees depend on class. A Class C or D non-IVD device costs $3,000 per overseas site plus $1,500 per distinct device. Class B costs $2,000 per site and $1,000 per device, and Class A costs $1,000 per site and $50 per device. IVDs have lower per-product fees. The total cost of a medical device import license in India also includes consultant fees, apostilles, translations and any testing, so budget beyond the government amount. Check the MD-14 and MD-15 service page for help planning costs.
Can I import with only a CE mark or US FDA clearance?
No. A CE mark or US FDA clearance supports your application, but it does not replace Indian approval. CDSCO still expects an MD-15 license or, for eligible Class A devices, a portal registration. Approvals from reference markets such as the EU, US, UK, Canada, Australia and Japan do make the review smoother, since they show that another strict regulator has already assessed the device. Anyone asking how to get medical device import license in India quickly should upload those approvals with the latest certificate versions.
Do I need a separate license for every device model?
Not always. One MD-15 license can cover several devices from the same manufacturer and the same site, and CDSCO charges a fee for each distinct device on it. Adding a new model later usually needs an endorsement to the existing license rather than a new one. A different factory, however, needs its own site fee and review. Plan your product grouping when you prepare your CDSCO import license file, since smart grouping saves both money and review time.
What happens if I import medical devices without a license?
Customs can detain the shipment, order it re-exported or refuse clearance. Selling regulated devices without a license also breaks the Drugs and Cosmetics Act, 1940, which carries penalties and can damage your standing with hospital buyers for years. The safer path is to understand how to get medical device import license in India well before you place purchase orders, and to time shipments only after the MD-15 or Class A registration is in hand. Our regulatory solutions for importers page explains how we plan this sequence
How do I get a medical device import license in India?
To get a medical device import license in India, you appoint an Indian authorised agent, register on CDSCO's online medical device portal, file Form MD-14 with a Device Master File, Plant Master File and supporting certificates, pay the fee in US dollars, and answer CDSCO's queries. CDSCO then grants the license on Form MD-15.
What is the difference between Form MD-14 and MD-15?
Form MD-14 is the application you submit to CDSCO to import a medical device. Form MD-15 is the license CDSCO grants once it approves that application. In short, MD-14 is the request and MD-15 is the permission that lets customs release your devices.
How long is an MD-15 import license valid?
An MD-15 license has no fixed end date. It stays valid as long as you pay the retention fee every five years from the date of issue and CDSCO does not suspend or cancel it. Missing the payment and the grace period makes the license lapse.
Where do I apply for a CDSCO import license?
You apply online through CDSCO's medical device portal at cdscomdonline.gov.in, often called the SUGAM portal. The Indian authorised agent creates the account, uploads Form MD-14 and the technical files, and pays the government fee on the same portal. Status updates and queries also arrive there.
Getting the paperwork right the first time is the fastest answer to how to get medical device import license in India. A complete file, a reliable agent and quick query replies can turn a nine-month wait into a much shorter one. If you want a team that has walked this route many times, start with our medical device licensing and regulatory approvals in India service or talk to our regulatory experts. We will help you work out how to get medical device import license in India for your exact product range, so your first shipment clears customs on the date you planned.
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.
Facing medical device compliance bottlenecks or Notified Body review findings?
NKB Regovanta conducts thorough regulatory gap assessments, dossier remediation, and health authority liaison to secure market approvals with confidence.