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CDSCO import license for medical device in India
A CDSCO import license for medical device is a mandatory approval issued by India’s Central Drugs Standard Control Organisation (CDSCO) under the Ministry of Health and Family Welfare. Any foreign manufacturer or importer who wants to bring a medical device into India must obtain this license before selling, distributing, or stocking the product. The license is granted in Form MD-15, and the application is submitted in Form MD-14 through the official SUGAM portal. Without this license, importing a medical device into India is illegal under the Medical Device Rules (MDR), 2017. At TraccGlobal, we help companies navigate the entire process — from device classification to final approval — quickly and without confusion.
What Is a CDSCO Import License for Medical Device?
India’s medical device market is one of the fastest-growing in the world, projected to touch $370 billion by 2025. To protect the quality and safety of devices entering India, the Government made it compulsory for all foreign manufacturers and importers to get a CDSCO import license before selling any medical device in the country.
The CDSCO import license (also called MD-15 license) is the official regulatory approval that gives your company the legal right to import, stock, sell, and distribute medical devices in India. It is issued by the Central Licensing Authority (CLA) under CDSCO, which operates under the Directorate General of Health Services.
Before 2006, companies could freely bring medical devices into India without strict regulatory checks. The Medical Device Rules, 2017 changed everything — now all classes of medical devices (A, B, C, and D) require proper licensing, with the only exception being Class A non-sterile and non-measuring devices, which need self-certification instead of a formal license.
Why Is the CDSCO Import License Important?
If you are a foreign manufacturer or an Indian importer, the CDSCO import license is not optional — it is the law. Here is why it matters:
- Legal Entry: Without it, your product can be seized at customs and you can face legal action under the Drugs and Cosmetics Act, 1940.
- Market Access: It gives you the right to sell your device to hospitals, clinics, government tenders, and distributors across India.
- Patient Safety: CDSCO reviews the safety, quality, and performance data of your device before issuing the license. This protects patients.
- Business Trust: Healthcare buyers in India trust licensed products more. It directly impacts your business reputation.
- Post-Market Compliance: The license keeps you connected to CDSCO’s ongoing monitoring system, which is essential for long-term market presence.
Medical Device Risk Classification Under CDSCO
The first step in getting a CDSCO import license is classifying your device correctly. CDSCO uses a risk-based 4-class system under the Medical Device Rules, 2017:
| Class | Risk Level | Examples |
|---|---|---|
| Class A | Low risk | Thermometers, tongue depressors |
| Class B | Low to moderate risk | Hypodermic needles, suction pumps |
| Class C | Moderate to high risk | Ventilators, dialysis machines |
| Class D | High risk | Heart valves, implantable defibrillators |
Note: Class A non-sterile, non-measuring devices are exempt from the import license requirement but must be self-certified.
Who Needs a CDSCO Import License for Medical Device?
The following types of businesses must obtain a CDSCO import license before importing medical devices into India:
- Foreign manufacturers who want to sell devices directly or through Indian distributors
- Indian importers and authorised agents who hold a valid wholesale or manufacturing license
- Distributors and wholesalers who source devices from outside India
- Companies importing raw materials or semi-finished components that are assembled into final medical devices in India (manufacturing license also required in such cases)
CDSCO Import License Requirements — Documents Checklist 2026
Getting your documents right the first time is critical. Incomplete or wrong documents are the most common reason for delays and rejections. Here is a complete list of CDSCO import license requirements:
Mandatory Documents for All Classes:
- Duly filled Form MD-14 application (submitted via SUGAM portal)
- Power of Attorney from the foreign manufacturer to the Indian Authorised Agent
- Free Sale Certificate (FSC) from the country of origin — confirms the device is legally sold in its home market
- ISO 13485 Certificate (Quality Management System certification)
- Device Master File (DMF) — detailed technical documentation of the device
- Plant Master File (PMF) — details about the manufacturing site
- Declaration of Conformity (DoC) as per prescribed formats
- Approval or registration certificate from a GHTF country (US FDA, CE Mark, TGA, Health Canada, etc.) — especially critical for Class C and D
- Labelling details as per CDSCO norms
- Test reports from a CDSCO-approved or internationally recognised lab
- Wholesale Drug License in Form 20B or 21B for the Indian agent
- Clinical Evaluation Report (CER) for Class C and D devices
For Class C and D Devices Specifically:
- If your device does NOT have a Free Sale Certificate from countries like USA, EU, Australia, Canada, or Japan — you may need to conduct clinical investigations in India, which adds to the timeline
- CDSCO may conduct a manufacturing site inspection before granting the license
Step-by-Step Process to Get a CDSCO Import License for Medical Device
Here is how the process works, from start to getting your MD-15 license in hand:
Step 1: Classify Your Device
Identify the risk class of your device — A, B, C, or D — based on CDSCO’s classification list published under the Medical Device Rules, 2017. Getting this right is the foundation of your entire application.
Step 2: Appoint an Indian Authorised Agent
Foreign manufacturers cannot apply directly to CDSCO. You must appoint an Indian Authorised Agent (IAA) — a licensed importer, wholesaler, or distributor — who will act as your official representative in India. The IAA must hold a valid wholesale drug license (Form 20B/21B) or a registration certificate (Form 41/42).
Step 3: Register on the SUGAM Portal
The SUGAM portal (sugam.gov.in) is CDSCO’s official online platform. Your authorised agent must register your company on this portal before any application can be submitted.
Step 4: Prepare Your Document Dossier
Compile all required documents — DMF, PMF, FSC, ISO certificates, test reports, etc. This is the most time-consuming part of the process and needs expert attention to avoid query letters or rejection.
Step 5: Submit Form MD-14
The authorised agent submits Form MD-14 online through the SUGAM portal. This is the formal application for the import license. All device details, classification, intended use, and manufacturer information are filled in here.
Step 6: Pay Government Fees
Pay the applicable CDSCO import license fees online through the portal. Fee amounts vary by device class and number of devices (see the Fee section below).
Step 7: CDSCO Technical Review
CDSCO officials review your application and documents. They may raise queries (deficiency letters) asking for additional information or clarifications. You must respond to all queries thoroughly and on time.
Step 8: Site Inspection (For Class C & D)
For Class C and D devices, CDSCO may conduct a site inspection of the manufacturing facility within 60 days of the application date. The inspection checks GMP compliance and manufacturing standards.
Step 9: Grant of MD-15 Import License
Once all queries are resolved and documents are approved, CDSCO issues the import license in Form MD-15. This is your legal document to start importing, selling, and distributing the medical device in India.
CDSCO Import License Fees for Medical Devices (2026)
The CDSCO import license fees depend on the risk class of your device. Below is the current fee structure as per Medical Device Rules, 2017 and subsequent amendments. Note that import license fees are paid to the Central Licensing Authority (CLA), unlike manufacturing licenses which may go to state authorities.
| Fee Type / Class | Approximate Government Fee |
|---|---|
| Import License — Class A & B (per site) | ₹ 83,300 approx. |
| Import License — Class C & D (per site) | ₹ 2,49,900 approx. |
| Single Device Registration Fee | USD 1,000 equivalent in INR |
| Each Additional Device (same application) | USD 1,000 equivalent in INR |
| Manufacturing Site Registration | USD 1,500 equivalent in INR |
| Site Inspection (if required) | USD 5,000 equivalent in INR |
| Retention Fee (every 5 years) | Same as original fee schedule |
Important: Fees are paid online via the SUGAM portal. Fees are subject to change — always confirm the latest fee on the official CDSCO website or consult a CDSCO import license consultant before applying.
The import license granted under MD-15 is valid indefinitely — meaning it does not expire in the traditional sense. However, you must pay a retention fee every 5 years to keep the license active. If the retention fee is not paid on time, a late fee is charged for each month of delay.
How Long Does the CDSCO Import License Process Take?
The approval timeline depends on the class of your device and how well-prepared your documents are:
| Device Class | Typical Timeline | Notes |
|---|---|---|
| Class A & B | 1 – 3 months | Faster if documents are complete |
| Class C | 3 – 6 months | May include site inspection |
| Class D | 6 – 9+ months | CER and inspection almost always needed |
Key Forms Used in CDSCO Import License Process
Here is a quick reference to the forms you will encounter:
- Form MD-14 — Application form for import license (submitted by the Indian Authorised Agent on SUGAM portal)
- Form MD-15 — The actual Import License issued by CDSCO (the document you want to receive)
- Form MD-16 — Application for a test/clinical investigation license (for small quantities, research, or demonstration purposes)
- Form MD-17 — Test/import license issued for clinical investigation or evaluation purposes
- Form 20B / 21B — Wholesale drug license needed by the Indian Authorised Agent
Common Challenges and How to Avoid Them
Many applicants face delays or rejections because of avoidable mistakes. Based on real-world experience with the CDSCO process, here are the most common problems and how to avoid them:
1. Wrong Device Classification
Classifying your device under the wrong risk class is one of the most common errors. It leads to submitting the wrong documents and paying the wrong fee. Always verify classification carefully before starting your application.
2. Incomplete Documentation
Missing documents — like an outdated Free Sale Certificate, an incorrect Power of Attorney, or an incomplete Device Master File — are the biggest causes of query letters and delays. Prepare and double-check every document against the official CDSCO checklist before submitting.
3. No FSC from Recognised Countries (Class C & D)
If your Class C or D device does not have a Free Sale Certificate from the USA, EU, Australia, Canada, or Japan, CDSCO may require clinical investigation in India. This can add months or even years to your timeline. Plan ahead and consider getting regulatory approval in one of these markets first.
4. Delays in Responding to CDSCO Queries
If CDSCO sends a deficiency letter (query), you must respond quickly and correctly. Delayed or incomplete responses extend the approval timeline significantly.
5. Choosing the Wrong Authorised Agent
Your Indian Authorised Agent is your legal representative with CDSCO. Choosing someone without the right license or experience can cause serious compliance issues. Make sure your agent holds a valid wholesale drug license and understands CDSCO regulations.
Post-Approval Compliance: What You Must Do After Getting the License
Getting the MD-15 license is just the beginning. To keep your license active and stay compliant, you must follow these ongoing requirements:
- Post-Market Surveillance (PMS): Report any adverse events, product defects, or safety issues to CDSCO promptly.
- Periodic Safety Updates: Regularly review and update safety data for your device.
- Retention Fee Payment: Pay the renewal or retention fee every 5 years. Missing the deadline results in late fees.
- Update CDSCO on Changes: Any changes to the device, manufacturer details, manufacturing site, or the Authorised Agent must be communicated to CDSCO in writing promptly.
- Label Compliance: Ensure all product labels continue to meet CDSCO’s labelling requirements, including QR codes and required declarations.
Why Choose TraccGlobal as Your CDSCO Import License Consultant?
Getting a CDSCO import license on your own is possible — but slow, confusing, and risky if you are not familiar with Indian regulatory requirements. A small mistake in your documents can delay your market entry by months. That is why working with an experienced CDSCO import license consultant like TraccGlobal makes sense.
At TraccGlobal, we specialise in medical device regulatory affairs for the Indian market. Here is what we do for our clients:
- Free initial consultation to understand your device, classification, and regulatory pathway
- Complete document preparation — DMF, PMF, FSC guidance, ISO coordination, DoC, and more
- SUGAM portal registration and Form MD-14 submission on your behalf
- Query management — we handle all CDSCO queries quickly and professionally
- Authorised Indian Agent services if you need a local representative in India
- Post-approval compliance support — PMS, renewals, change notifications
- End-to-end project management with clear timelines and transparent communication
Whether you are a first-time importer entering the Indian market or an established company dealing with a complex Class D device, TraccGlobal’s team of regulatory experts will guide you through every step. We know the process inside out — and we know how to get your approval done right, the first time.
Key 2026 Updates You Should Know About
The Indian medical device regulatory landscape is evolving quickly. Here are some important updates that are relevant for 2026:
- All medical devices (except Class A non-sterile, non-measuring) are now under the mandatory licensing regime as per the February 2020 amendment.
- CDSCO has introduced auto-generated compliance certificates — market standing and non-conviction certificates can now be generated digitally for licensed entities on the SUGAM portal.
- A Neutral Code for Export is now available — a system-generated code for manufacturers exporting devices from India.
- Annual device registration fees are expected to come into effect from April 2026 — importers and manufacturers should plan their budgets accordingly.
- Pharmacies are now required to display QR codes and toll-free numbers for reporting incidents as part of improved drug and device safety measures.
- The SUGAM portal continues to be upgraded for faster online processing and better applicant communication.
Ready to Get Your CDSCO Import License for Medical Device?
Do not let regulatory complexity slow down your entry into India’s booming healthcare market. Whether you are launching a new product or need help renewing an existing license, TraccGlobal’s team of CDSCO import license consultants is ready to help.
We make the process simple, fast, and stress-free — so you can focus on your business while we handle the regulatory work.
Contact TraccGlobal Today for a Free Consultation
Frequently Asked Questions (FAQ) — CDSCO Medical Device Registration
Q1. What is the validity of a CDSCO import license for medical devices?
The CDSCO import license (Form MD-15) is valid indefinitely — it does not expire automatically. However, you must pay a retention fee every 5 years to keep the license active. If you do not pay on time, you will be charged a late fee.
Q2. Can a foreign manufacturer apply for a CDSCO import license directly?
No. Foreign manufacturers cannot apply directly to CDSCO. They must appoint an Indian Authorised Agent (who holds a valid wholesale or manufacturing license in India) to apply on their behalf through the SUGAM portal.
Q3. Is a CDSCO import license required for Class A devices?
Class A non-sterile and non-measuring devices are exempt from the formal import license requirement. They require self-certification instead. However, Class A sterile or measuring devices do require an import license.
Q4. What is Form MD-14 and Form MD-15?
Form MD-14 is the application form that your Indian Authorised Agent submits to CDSCO requesting an import license. Form MD-15 is the actual import license issued by CDSCO after approval. You need Form MD-15 to start legally importing your device.
Q5. What are the CDSCO import license fees?
Import license fees depend on the class of your device. As a general guide: Class A & B devices cost approximately ₹83,300 per site, while Class C & D devices cost approximately ₹2,49,900 per site. Additional device registration fees of USD 1,000 per device also apply. Always confirm the latest fee structure on the CDSCO website or with a qualified consultant.
Q6. What happens if I import medical devices without a CDSCO import license?
Importing medical devices without a valid CDSCO import license is illegal under the Drugs and Cosmetics Act. Your products can be seized at customs, you can face heavy financial penalties, and legal proceedings can be initiated against you and your Indian agent.
Q7. What is the SUGAM portal?
SUGAM (sugam.gov.in) is CDSCO’s official online portal for submitting all regulatory applications, including import license applications. All applications are submitted, tracked, and managed digitally through this platform.
Q8. How can TraccGlobal help me get my CDSCO import license faster?
TraccGlobal’s regulatory team handles everything — from device classification and document preparation to SUGAM portal submission and CDSCO query responses. Our experience with the process helps reduce errors and speeds up approval timelines. Visit https://traccglobal.com/ to learn more or contact us for a free consultation.
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