MD-14 & MD-15 Import License: Answers to Most Searched Questions
Confused About MD-14 and MD-15? You’re Not Alone
If you’ve been searching about MD-14 or MD-15, chances are you’re planning to import medical devices into India.
And somewhere along the way, things started feeling… complicated.
Different forms. Technical terms. Unclear steps.
The good news? Once you understand how the system works under the Central Drugs Standard Control Organization, everything becomes much easier to manage.
Let’s answer the most common questions people like you are searching.
What is MD-14 in CDSCO?
MD-14 is the application form used to apply for an import license for medical devices in India.
It includes:
Importer details
Manufacturer information
Device specifications
Regulatory documents
Think of it as your first step toward legal approval.
What is MD-15 License?
MD-15 is the final import license issued after approval of MD-14.
Once you receive MD-15, you are officially allowed to:
Import medical devices
Sell them in the Indian market
What is the Difference Between MD-14 and MD-15?
A simple way to understand:
MD-14 → Application stage
MD-15 → Approval stage
Without MD-14, you cannot get MD-15.
Who Needs MD-14 & MD-15 Import License?
You must apply if you are:
A medical device importer
An Indian agent for a foreign manufacturer
A distributor importing products for sale
How to Apply for MD-14 and MD-15?
Here’s a simplified process you can follow:
Step 1: Register Online
Create your account on the CDSCO Sugam Portal
Step 2: Classify Your Device
Devices are categorized into Class A, B, C, and D.
This affects your documentation and fees.
Step 3: Prepare Documents
You’ll need:
Device Master File (DMF)
Plant Master File (PMF)
ISO 13485 certificate
Free Sale Certificate
Authorization letter
Step 4: Submit MD-14 Application
Upload documents carefully and pay fees.
Step 5: Respond to Queries
CDSCO may ask questions—respond quickly and clearly.
Step 6: Get MD-15 License
After approval, your import license is issued.
What Documents Are Required for MD-14?
Most commonly required documents include:
Device Master File (DMF)
Plant Master File (PMF)
ISO certification
Clinical data (if required)
Power of Attorney from manufacturer
Missing even one document can delay approval.
What is CDSCO Import License Fees?
Fees depend on:
Device category
Number of products
Manufacturing sites
Always confirm the latest structure before applying.
How Long Does MD-15 Approval Take?
On average:
3 to 6 months
It can vary based on:
Document accuracy
Query response time
Device classification
Common Mistakes to Avoid
Many applications get delayed due to small errors:
Wrong device classification
Incomplete documentation
Incorrect portal submission
Delayed query responses
Avoiding these can save you a lot of time.
Key Benefits of MD-14 & MD-15 License
Once approved, you gain:
Legal access to Indian market
Faster distribution channels
Higher trust among buyers
Long-term business growth
Why Expert Guidance Makes a Difference
The process is detailed, and every step matters.
Working with a consultant helps you:
Avoid common mistakes
Prepare strong documentation
Handle queries efficiently
Speed up approval
It’s not just about applying—it’s about applying correctly.
Conclusion EVTL India is one of the leading BIS Consultant in India, helping manufacturers obtain their BIS licences hassle-free.
MD-14 and MD-15 are essential if you want to import medical devices into India.
The process may look complex at first, but with the right understanding, it becomes structured and manageable.
Take your time. Prepare properly.
And if you want a smoother journey, consider expert support to get it right the first time.
FAQs
1. What is MD-14 used for?
It is used to apply for an import license for medical devices.
2. What is MD-15?
It is the final license issued after approval of MD-14.
3. Can I apply for MD-14 online?
Yes, through the CDSCO Sugam Portal.
4. Is CDSCO approval mandatory?
Yes, for all notified medical devices in India.
5. Who can apply for import license?
Indian importers or authorized agents of foreign manufacturers.