Medical Device Import License Consultant in India | The 2026 Guide to MD-14 and MD-15
Medical Device Import License Consultant in India | The 2026 Guide to MD-14 and MD-15 - NKB Regovanta
Table of Contents
17 sections in this regulatory guidance
Bringing a medical device into India takes more than a buyer, a shipment and a customs broker. Every device, from a Class A alcohol swab to a Class D heart valve, needs a licence from the Central Drugs Standard Control Organisation (CDSCO) before it clears the port. A medical device import license consultant in India helps foreign manufacturers and Indian distributors get that licence right the first time.
The form itself is rarely the problem. Most delays come from a wrong class, a thin technical file or an agent who holds the wrong Indian licence. Each mistake adds a query round, and each round can cost weeks.
This guide explains how the CDSCO import licence works under the Medical Device Rules 2017, what it costs, how long it takes and how to pick a consultant who will actually shorten the process.
What Does a Medical Device Import License Consultant in India Do?
A medical device import license consultant in India manages the regulatory side of getting a device approved for import. That covers classification, dossier writing, online filing, query replies and upkeep after approval. The good ones also tell you early when a product is not ready to file.
In practice, the consultant sits between three parties. The foreign manufacturer owns the technical data. The Indian Authorized Agent applies for and holds the licence. CDSCO reviews the file. The consultant keeps all three aligned, so the application tells one consistent story from the first page to the last.
The Short Answer for Busy Importers
Here is the one-line version. A consultant turns your existing global approvals and technical files into an Indian application that CDSCO can approve without repeated queries.
Most manufacturers already hold CE marking or US FDA clearance. The consultant reuses that evidence, fills the India-specific gaps and files it under Form MD-14. You can see how this fits into a wider India CDSCO regulatory strategy, and how our team approaches medical device registration in India by defining the applicant, product and route first.
Why India Requires a Medical Device Import Licence
India regulates devices under the Medical Device Rules 2017, framed under the Drugs and Cosmetics Act, 1940. The rules took effect in January 2018 and expanded in phases. Class A and B devices came under licensing in October 2022, and Class C and D devices followed in October 2023.
Today almost every device sold in India needs either a manufacturing licence or an import licence. The agent applies on Form MD-14, and CDSCO grants the MD-15 licence. Customs officers ask for this licence at the port. Without it, your shipment waits.
CDSCO publishes its import and registration requirements openly. Its official FAQ on the Medical Devices Rules answers many basic questions too. The rules are public. Applying them correctly to your specific product is where expertise pays off.
Who Needs a Medical Device Import License Consultant in India?
Two groups hire outside help most often. Each faces a different problem, so each needs a slightly different kind of support.
Foreign Manufacturers Entering India
Overseas manufacturers cannot hold an Indian import licence directly. They must appoint an Indian Authorized Agent through a notarised and apostilled Power of Attorney.
Many first-time entrants also struggle to map their EU or US technical files to the Indian format. A consultant closes both gaps. For companies planning several markets at once, it helps to sequence markets around reusable evidence so India does not become a separate project.
Indian Distributors and Importers
Indian distributors usually own the commercial relationship but not the technical data. They need the manufacturer's master files and certificates in a form CDSCO accepts.
The distributor also needs its own Indian licence to act as agent, such as a wholesale licence or a medical device sale registration. Our drug licence support for importers covers this groundwork before the MD-14 filing starts.
Get Device Risk Classification Right Before You Apply
Classification decides almost everything that follows: fees, documents, review depth and timeline. CDSCO sorts devices into four device risk classification groups.
Table 1: CDSCO device classes with typical examples
| Class | Risk level | Typical examples |
|---|---|---|
Class A | Low | Alcohol swabs, absorbent cotton |
Class B | Low to moderate | Hypodermic needles, digital thermometers |
Class C | Moderate to high | Bone fixation plates, lung ventilators |
Class D | High | Heart valves, coronary stents |
CDSCO publishes classification lists by therapeutic area. When your product does not appear, you apply the rule-based criteria in the First Schedule, and that is where mistakes creep in. Software, accessories and drug-device combinations cause the most confusion.
Our guide on borderline product classification explains how to separate two questions: is it a device at all, and which class does it fall into? A wrong answer can mean a rejected file and a second fee, so write down the rationale before you draft a single dossier page.
Step-by-Step MD-14 to MD-15 Process With an Import License Consultant
Most applications follow the same five stages. Order matters, because each step depends on the one before it.
Step 1: Classify and Group Your Products
Confirm the class of each device and decide how to group variants. CDSCO charges fees per foreign site and per distinct device, so sensible grouping by generic name, intended use and design can cut costs. Do not force unrelated models into one family, though. Reviewers will split them and ask for more fees.
Step 2: Appoint the Indian Authorized Agent
Choose an agent who holds a valid manufacturing licence, a wholesale licence or a medical device sale registration. The manufacturer signs a Power of Attorney that names the agent and lists every device. Check that names and addresses match across all certificates. Small spelling differences are a classic query trigger.
Step 3: Build the Device and Plant Master Files
The Device Master File (DMF) describes the product: design, materials, risk management, verification, clinical evidence and labels. The Plant Master File (PMF) describes the manufacturing site and its quality controls. Both follow formats set out in the rules. Strong technical documentation and DHF support makes this the fastest stage instead of the slowest.
Step 4: File Form MD-14 on the SUGAM Portal
The agent submits Form MD-14 on CDSCO's online medical devices system, which many in the trade still call the SUGAM portal. The filing carries the fee payment, DMF, PMF, Power of Attorney, Free Sale Certificate and quality certificates.
Step 5: Answer Queries and Receive the MD-15 Licence
CDSCO reviews the file and may raise queries. Some higher-risk or novel devices may also go to an expert committee. Once satisfied, CDSCO grants the licence on Form MD-15. It stays valid as long as the holder pays the retention fee every five years and the licence is not suspended or cancelled.
Documents Your Medical Device Import License Consultant in India Will Request
Expect this list in the first week of the project. Start early, because apostille and legalisation steps abroad can easily take a month.
Table 2: Core documents for a CDSCO import licence
| Document | What it proves | Common problem |
|---|---|---|
Power of Attorney | The agent's authority | Not apostilled, or device list incomplete |
Free Sale Certificate | Legal sale in the origin country | Expired, or model names differ |
ISO 13485 certificate | A working quality system | Scope does not cover the product |
CE certificate or FDA clearance | Approval in a reference market | Model numbers do not match the DMF |
Device Master File | Design, safety and performance data | Missing risk file or stability data |
Plant Master File | Manufacturing site controls | Outdated site layout or process flow |
Labels and IFU | India labelling compliance | No importer name or licence number |
Agent's Indian licence | Agent eligibility | Expired or wrong licence category |
Indian labels must show the importer's name, address and import licence number. Many foreign labels skip these details, so plan a compliant sticker or updated artwork well before the first shipment.
Behind every good file sits a real quality system. If yours needs work, look at our ISO 13485 certification support, since ISO 13485 certification is one of the first things CDSCO reviewers check. This note on turning compliance records into regulatory evidence is also worth a read.
CDSCO Import Licence Fees and Timelines in 2026
Government fees depend on three things: device class, number of foreign manufacturing sites and number of distinct devices. The figures below come from CDSCO's official fee schedule.
Table 3: Government fees for an import licence (Form MD-14)
| Category | Fee per site | Fee per distinct device |
|---|---|---|
Class A (non-IVD) | US$1,000 | US$50 |
Class B (non-IVD) | US$2,000 | US$1,000 |
Class C and D (non-IVD) | US$3,000 | US$1,500 |
Class A and B (IVD) | US$1,000 | US$10 |
Class C and D (IVD) | US$3,000 | US$500 |
Take a simple example. A European company importing four distinct Class C devices from one site pays US$3,000 plus 4 × US$1,500. That totals US$9,000 in government fees, before any consultant fee.
Timelines vary with class and file quality. In our experience, Class A and B files often close in six to nine months, while Class C and D files take nine to twelve months. Every query round adds weeks. So the real lever is a clean first submission, not follow-up phone calls.
Why CDSCO Raises Queries on Import Files
Queries are the single biggest cause of delay, and most of them repeat across companies. Reviewers flag the same handful of gaps again and again.
The first is mismatched data. A model number appears one way in the Free Sale Certificate, another way in the CE certificate and a third way on the label. The second is a weak risk file, where hazards are listed but not linked to tests or design controls. The third is missing stability or shelf-life evidence for sterile and single-use products.
Label gaps come next. Reviewers look for the importer's details, the licence number, the manufacturing date and the expiry date. Finally, many files lack a clear essential principles checklist that points to where each requirement is met in the dossier.
An experienced medical device import license consultant in India reviews the file against these triggers before submission. That one internal review often saves a full query cycle.
Medical Device Import License Consultant in India vs. Filing In-House
Some companies ask whether they can simply file themselves. They can. The comparison below shows what usually changes when a specialist runs the file.
Table 4: Consultant-led filing compared with a first-time in-house filing
| Factor | With a consultant | First-time in-house filing |
|---|---|---|
Classification | Written rationale agreed up front | Often guessed from similar products |
Dossier format | Mapped to CDSCO's required structure | Global file reused with gaps |
Query rounds | Usually one or none | Often two or more |
Time to MD-15 | Predictable | Hard to forecast |
Internal effort | Review and sign-off only | High, with learning on the job |
Cost | Consultant fee | Fee saved, but delay costs sales |
In-house filing makes sense if you already employ someone who has handled CDSCO device files. For everyone else, the numbers usually favour outside help. One extra quarter of delay on a product line can cost more than the whole consultancy fee.
A regulatory affairs consulting partner also gives you continuity. When CDSCO changes a rule, you hear about it before your next new-product filing, not after a rejection.
How to Choose the Right Medical Device Import License Consultant in India
Not every firm offers the same depth. Run through these checks before you sign an engagement letter:
Ask for recent MD-15 approvals in your device class, not just general CDSCO experience.
Check whether the firm writes the full DMF and PMF or only files forms that others prepare.
Confirm who answers CDSCO queries and how quickly they commit to respond.
Ask whether they know your other markets, such as EU MDR or US FDA, so they can reuse evidence.
Get a written scope that separates government fees, consultant fees and exclusions.
Check whether they handle related approvals like WPC, PC-PNDT and IEC registration.
Ask how they manage post-approval changes, such as new models, sites or labels.
A firm with global medical device and IVD registration experience can plan India alongside the EU, US and Gulf markets. That saves duplicate testing and a lot of rewriting. If you are buying or investing in a device business, regulatory due diligence tells you which Indian licences actually exist.
Related Approvals Importers Often Miss
The MD-15 licence is the main approval, but it is rarely the only one. Several product types need extra clearances before they ship or sell.
Wireless devices, such as Bluetooth glucose meters or Wi-Fi patient monitors, need equipment type approval from the WPC wing. See our WPC approval service for wireless medical devices. Ultrasound machines and other imaging equipment capable of sex determination need a PC-PNDT certificate, covered under our PC-PNDT registration support.
Every importer also needs an Importer Exporter Code from DGFT and an AD code registered with customs at the port. We handle IEC and AD code registration as part of market setup. If you later plan to make devices in India, the route changes again, as our guide to CDSCO manufacturing licences explains.
2026 Rule Changes a Medical Device Import License Consultant in India Is Tracking
India's device rules keep evolving. In 2026, the health ministry released draft amendments to the Medical Device Rules, and industry reporting on the draft highlights two changes that matter to importers.
First, the draft proposes adding EU-approved devices to the list of reference markets whose approvals can waive certain clinical investigation data. Today that relief covers devices approved in the US, UK, Japan, Australia and Canada. Second, it proposes a quality management system requirement for Class A self-certification.
These are proposals, and the final text may differ. Our note on India MDR 2026 and Rule 63 tracks what EU-approved devices may gain. For the wider package, this legal analysis on Mondaq walks through each proposed rule.
Where Importers Compare Notes on Reddit
First-time importers and regulatory professionals often swap experiences online. Reddit gives you a ground-level view, although you should always check any advice against CDSCO's own documents.
r/MedicalDevices hosts discussions on regulatory submissions across markets. r/regulatoryaffairs is where RA professionals talk about dossiers, agency queries and careers. r/IndiaBusiness and r/indianstartups carry posts from founders setting up import and distribution businesses.
To find the latest posts and comments on this exact topic, run a Reddit search for CDSCO import licence discussions. Look for threads on classification, query handling and distributor agreements, because those three issues decide most outcomes.
Frequently Asked Questions About Medical Device Import License Consultants in India
How much does a medical device import license consultant in India charge?
Consultant fees depend on device class, the number of products and how much of the dossier the firm must write. A medical device import license consultant in India should quote government fees and professional fees separately. Ask for a fixed-scope quote that lists what happens if CDSCO raises extra queries, so the final bill holds no surprises. You can book a consultation for a scoped estimate.
Can a foreign manufacturer hold an MD-15 licence directly?
No. A foreign manufacturer must appoint an Indian Authorized Agent, who applies on Form MD-14 and holds the MD-15 licence. The agent needs a valid Indian manufacturing licence, wholesale licence or sale registration. A Power of Attorney links the two parties and lists every device covered. The manufacturer can change agents later, but that means a fresh application.
Is the MD-15 import licence valid forever?
The MD-15 licence has no fixed expiry date. It stays valid as long as the holder pays the retention fee every five years and CDSCO does not suspend or cancel it. Any major change, such as a new site, new model or new agent, needs CDSCO approval or a fresh application.
Do I need clinical trial data in India to import a device?
Usually not, if the device already holds approval in a recognised reference market and has a predicate on the Indian market. Novel devices may need a clinical investigation. To import small quantities for testing, evaluation or demonstration before full approval, apply for a test licence on Form MD-16, which CDSCO grants on Form MD-17. A medical device import license consultant in India can tell you which route applies.
Can one Indian distributor hold import licences for several brands?
Yes. One Indian agent can hold separate import licences for several foreign manufacturers, provided each manufacturer signs its own Power of Attorney and each product line goes through its own application. Distributors who represent many brands should track retention fees and label requirements for every licence separately.
Who issues the medical device import licence in India?
The Central Drugs Standard Control Organisation, known as CDSCO, issues medical device import licences in India. The Drugs Controller General of India heads CDSCO and acts as the Central Licensing Authority. The Indian agent applies online on Form MD-14, and CDSCO grants the licence on Form MD-15.
How long does it take to get a medical device import licence in India?
It usually takes six to twelve months to get a medical device import licence in India. Low-risk Class A and B devices often close faster. High-risk Class C and D devices take longer. A complete first submission with clean documents is the best way to avoid extra query rounds.
What is the difference between MD-14 and MD-15?
MD-14 is the application form, and MD-15 is the licence itself. The Indian Authorized Agent files Form MD-14 with the device dossier and fees. After review, CDSCO grants the import licence on Form MD-15, which customs officers check when the shipment arrives.
Do I need a consultant to import medical devices into India?
You do not legally need a consultant, but most first-time importers use one. A medical device import license consultant in India knows CDSCO's document format, common query triggers and related approvals. That experience usually cuts months off the timeline and avoids paying application fees twice.
India's device market rewards companies that arrive prepared. The right medical device import license consultant in India gets your classification, master files and agent structure right before CDSCO ever sees the file, so your MD-15 arrives on a predictable timeline. NKB Regovanta works as a medical device import license consultant in India for manufacturers across Europe, the US and Asia, and our regulatory affairs consulting team covers the EU, US, UK and Gulf markets too. Explore our India CDSCO services or book a consultation to plan your filing, and start selling in India with fewer surprises.
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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