Mon, Jan 19 2026
Raju Karn
MD-15 License for Class C & Class D Medical Devices (2026)
If you plan to manufacture or import advanced medical devices in India, you must have the MD-15 license. This license is required for Class C and Class D devices, which are higher-risk products. Without it, selling or distributing these medical devices in India is not allowed.
This blog explains the MD-15 license in easy and simple language. You will learn what the license is, why it is important, and the steps to get it. Even if you are new to medical device regulations, this guide will help you understand the process clearly and confidently.
What is an MD-15 License?
The MD-15 license is an official approval from the CDSCO that allows you to import high-risk medical devices (Class C and Class D) into India. This license ensures that imported devices meet India’s safety and quality standards before they reach hospitals and patients.
In simple terms:
- Your device is high-risk
- You are importing it from another country
- You cannot sell or distribute it without MD-15 approval
Why it matters:
- Ensures safety and quality of medical devices in India
- Makes your imports legal and compliant with the law
- Builds trust with hospitals, clinics, and patients
The MD-15 license is issued under the Medical Devices Rules, 2017, and requires submission of technical documents, manufacturer details, and compliance reports. Following the rules carefully helps you get approval smoothly and avoid legal issues.
What is CDSCO?
CDSCO stands for Central Drugs Standard Control Organisation. It works under the Ministry of Health & Family Welfare, Government of India. CDSCO is the main authority that regulates drugs and medical devices in India to ensure they are safe and effective for use.
Key roles of CDSCO:
➜ Control drugs and medical devices to meet quality and safety standards
➜ Approve licenses for manufacturing, importing, and selling medical products
➜ Ensure patient safety by monitoring adverse effects and compliance
➜ Regulate imports and manufacturing to maintain legal and quality standards
In simple words, CDSCO is the authority that makes sure all medicines and medical devices in India are safe, reliable, and legally compliant before they reach patients.
What are Class C and Class D Medical Devices?
and examples of Class C & D devices:
| Class | Risk Level | Description | Examples |
|---|---|---|---|
| A | Low | Devices with minimal risk to patients | Bandages, Thermometers, Surgical gloves |
| B | Low to Moderate | Devices with slightly higher risk but not life-threatening | Syringes, Blood pressure monitors, Infusion pumps |
| C | Moderate to High | Devices that can affect health if they fail; require careful regulation | Ventilators, Dialysis machines, Cardiac stents |
| D | High | Life-saving or life-support devices; failure can be fatal | MRI/CT scanners, Implantable medical devices, Heart valves |
Key Point:
Class C and D devices are strictly regulated because they directly impact human life, which is why importing or selling them in India requires the MD-15 license issued by CDSCO.
Examples of Class C & D Medical Devices
Class C and D devices are high-risk medical devices that can directly affect human life. Because of this, the government regulates them very strictly to ensure safety and quality.
| Device Type | Purpose / Use |
|---|---|
| Ventilators | Help patients breathe when they cannot do so on their own |
| Dialysis Machines | Support kidney function in patients with kidney failure |
| Cardiac Stents | Keep blocked arteries open to maintain blood flow |
| MRI and CT Scan Equipment | Diagnose and monitor internal body conditions |
| Implantable Medical Devices | Devices placed inside the body, like pacemakers |
| Heart Valves | Replace or repair damaged heart valves |
Who Needs an MD-15 License?
If you want to import high-risk medical devices (Class C or Class D) into India, you must have an MD-15 license. This license ensures that the devices meet safety, quality, and regulatory standards before they can be sold or distributed in India.
You need an MD-15 license if:
➤ You are importing Class C or D medical devices
➤ The device is manufactured outside India
➤ You want to sell or distribute it in India
➤ You are acting as an Authorized Indian Agent (AIR) for a foreign manufacturer
Key Point: Without an MD-15 license, importing or selling these high-risk devices is illegal, and non-compliance can lead to fines, seizure of products, or other legal actions.
Why MD-15 License is Important
MD-15 license is important because:
➝ It ensures patient safety
➝ It allows legal import
➝ It builds trust with hospitals
➝ It avoids penalties and seizure
➝ It protects your business from legal trouble
Without this license:
- Products can be seized
- Imports can be stopped
- Heavy penalties may be imposed
Where Do You Apply for MD-15 License?
The application is done online using the CDSCO MD Online portal.
Commonly used terms:
▪ CDSCO online
▪ CDSCO MD online
▪ SUGAM portal (for medical device licensing)
Everything is now digital. No physical files are accepted.
Documents Required for MD-15 License
Here are the main documents, explained simply:
→ Import license application (Form MD-14)
→ Free Sale Certificate from country of origin
→ Device Master File (DMF)
→ Plant Master File (PMF)
→ CE certificate (if available)
→ Authorization letter from manufacturer
→ Indian Agent details
→ Undertaking and declarations
→ Labeling details
→ Risk classification proof
These documents help CDSCO understand:
- How the device is made
- Whether it is safe
- Whether the manufacturer follows quality rules
Step-by-Step Process to Get MD-15 License
Getting an MD-15 license may seem complex, but following the steps carefully makes it smooth. This license is essential for importing Class C and Class D medical devices into India.
Step 1: CDSCO Login & Registration
- The importer or Authorized Indian Agent (AIR) creates an account on the CDSCO online portal.
- This account is used for all submissions and tracking the application.
Step 2: Prepare Documents
- Collect all technical, manufacturing, and legal documents related to the medical device.
- Double-check them to ensure they are complete and accurate before submission.
Step 3: Online Application Submission
- Fill out Form MD-14 on the CDSCO portal.
- Upload all the required documents along with the application.
Step 4: Fee Payment
- Pay the government fees online through the portal.
- Keep the payment receipt safe for future reference.
Step 5: CDSCO Review
- CDSCO officers review the application and documents.
- They may ask for additional clarification or documents if needed.
They may: - Ask questions
- Request clarification
- Ask for extra documents
Step 6: Approval & MD-15 License Issuance
Once satisfied, CDSCO issues the MD-15 import license.
How Long Does MD-15 Approval Take?
Normally:
45 to 90 days, depending on:
- Device complexity
- Document accuracy
- Query response time
High-risk devices may take slightly longer.
Validity of MD-15 License
The MD-15 license is valid for 5 years.
After expiry:
- Renewal must be applied before the due date
- Selling without renewal is illegal
Not sure whether you need an MD-15 license or how to apply?
Talk to our compliance expert and get clear guidance in simple language—no confusion, no pressure.
📞 Call PSR Compliance at 8796104190 or email us at : support@psrcompliance.com
We’ll help you understand the process and move forward the right way.
FAQs on MD-15 License for Class C & Class D Medical Devices
What is an MD-15 License?
An MD-15 License allows import of Class C and D medical devices in India under CDSCO.
Who needs an MD-15 License?
Foreign manufacturers need an Indian Authorized Agent to import Class C and D devices.
What is the difference between Class C and Class D devices?
Class C devices are moderate risk, while Class D devices are high-risk or life-supporting.
Can CE or FDA approval replace CDSCO approval?
No, CDSCO approval is mandatory for selling medical devices in India.
Which form is used to apply for an MD-15 License?
Form MD-14 is used to apply, and MD-15 is issued after approval.
What documents are required for an MD-15 License?
Key documents include QMS certificates, Device Master File, and authorization letters.
What is a Neutral Code in MD-15 licensing?
A Neutral Code is an identification code for specific devices or applicants.
How long does MD-15 approval take?
MD-15 approval usually takes 6 to 12 months, depending on documentation.
What is a change of constitution under MD-15?
Changes in ownership or company structure require CDSCO approval.
Is a new license required for minor device changes?
Yes, changes like sterilization methods may require fresh approval.
What about devices already in the market?
Existing devices may qualify under CDSCO transition or grandfathering provisions.
