Get Your CDSCO MD-15 Import LicenseImport Medical Devices into India
We help you navigate the regulatory path for importing medical devices. Our team ensures your application is complete and compliant for a smooth approval process. Avoid costly delays and rejections with our expert guidance.
What is CDSCO MD-15 Import License? Complete Guide 2024
The MD-15 Import License is your official approval to import Class B, C, and D medical devices into India. Without it, you cannot legally bring these products to market. The process is rigorous, but with the right guidance, you can avoid costly mistakes and delays.
Why Now is Critical
India's demand for advanced medical devices is surging. Early compliance means faster market entry and a competitive edge in a $50B+ industry. Don't let regulatory hurdles slow your growth.
Don't Risk Your Business
Importing without an MD-15 License can lead to severe penalties, recalls, and shutdowns. Compliance is not optional for Class B, C & D devices.
Who Needs This License?
How to Get MD-15 License: 5 Simple Steps
We break down the complex process into 5 clear steps for importers and foreign manufacturers.
Gather Required Documents
Collect all documents from both Indian agent and foreign manufacturer. Ensure accuracy and completeness to avoid delays.
Prepare & Submit MD-14 Application
Fill out the MD-14 form and upload all documents on the CDSCO MD Online portal. Pay the government fees as per device class.
CDSCO Review & Queries
CDSCO reviews your application and may raise queries. Respond promptly and accurately to avoid delays.
Audit & Inspection
CDSCO may audit the Indian agent's premises and review foreign manufacturer's compliance. Prepare for document and facility checks.
Get Your MD-15 License
If all is in order, CDSCO grants the MD-15 Import License, valid for 5 years and renewable.
MD-15 License Cost & Timeline: What to Expect
Total Timeline: 5-6 Months
Government Fees
| Risk Class | Per Site | Per Product |
|---|---|---|
| Class A | $1000 | $50 |
| Class B | $2000 | $1000 |
| Class C & D | $3000 | $1500 |
Why Choose Our Services?
MD-15 License Documents Required: Complete Checklist
Here is the full list of documents you need for a successful MD-15 application. Missing paperwork is the #1 reason for delays—let us review your documents before submission.
Pro Tip
We review every document before submission. Let us catch the issues before the government does.
MD-15 License Compliance: Keep Your Business Safe
Non-Compliance Risks
Failure to maintain compliance can result in license suspension or cancellation. Our team ensures you stay compliant with all regulatory requirements.
Success Tips
Double-check all documents for accuracy and completeness before submission.
Respond to CDSCO queries within 48 hours to avoid delays.
Keep digital and physical backups of all submissions and correspondence.
Assign a dedicated regulatory team or signatory to manage the process.
Monitor the CDSCO MD Online portal for updates and notifications.
"The team's expertise made our MD-15 import process seamless. They anticipated every query and got us approved on the first attempt. Highly recommended."
Common Mistakes
- Submitting incomplete or outdated documents.
- Ignoring CDSCO queries or missing deadlines.
- Not preparing for audits or inspections.
- Assuming Class A Non Sterile Non Measuring products require MD-15 (they do not).
- Not maintaining proper records post-approval.
Who Should Not Apply
- Importers of Class A Non Sterile Non Measuring products (use Class A Registration instead).
- Companies without a valid Indian agent or authorized representative.
- Applicants lacking a complete set of required documents.
Our Process vs DIY
| Aspect | With Us | DIY |
|---|---|---|
| Success Rate | 99% | 60% |
| Average Approval Time | 5-6 months | 8-12 months |
| Query Resolution | Within 24h | 1-2 weeks |
| Post-Approval Support | Yes | No |
Downloadable Resources
Case Studies
- US Manufacturer Secures MD-15 in 5 MonthsA leading US device company entered India with our help, overcoming document gaps and audit challenges for a smooth approval.
- EU Startup Avoids Costly DelaysA European startup avoided 6+ months of delays by using our expert team to preempt CDSCO queries and ensure compliance.
MD-15 License FAQ: Your Questions Answered
Real questions from real importers and manufacturers. Here are the answers you need.
Who needs an MD-15 Import License?
How long does the MD-15 process take?
Is a Test License required?
What is the application form for MD-15?
Does the license expire?
What are the most common reasons for rejection?
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