MD-14 & MD-15 Import License in India

Importing medical devices into India is a great business opportunity, but it requires strict regulatory approval. To legally import devices, companies must obtain a medical device import license from the Central Drugs Standard Control Organization (CDSCO).

This process involves applying through Form MD-14 and receiving approval in Form MD-15, as defined under the Medical Device As Per MDR 2017 regulations. In this blog, we explain the entire process in simple and easy language.

What is MD-14 and MD-15?

The MD-14 and MD-15 Import License is required for importing medical devices into India.

• Form MD-14: Application form submitted to CDSCO
• Form MD-15: License issued after approval

Once you receive MD-15, you are legally allowed to import and sell medical devices in India.

Importance of Medical Device Import License

A medical device import license is important because:

• It ensures product safety and quality
• It is mandatory under Indian law
• It builds trust with customers and hospitals
• It allows smooth business operations

Without this license, importing medical devices is not permitted.

Medical Devices As Per MDR 2017

Under the Medical Devices Rules 2017, devices are classified into four categories:

• Class A – Low risk
• Class B – Low to moderate risk
• Class C – Moderate to high risk
• Class D – High risk

The classification determines the approval process, documentation, and fees.

CDSCO Portal for Online Registration

All applications are submitted through the CDSCO SUGAM Portal.

Features of CDSCO Portal:

• Online form submission
• Document upload
• Fee payment
• Application tracking

This makes the process simple and transparent.

Step-by-Step MD-14 Application Process

Here is how to apply for the import license:

Step 1: Register on CDSCO Portal

Create an account and log in.

Step 2: Appoint Authorized Agent

Foreign manufacturers must appoint an Indian authorized agent.

Step 3: Prepare Documents

You will need:

• Free Sale Certificate (FSC)
• ISO 13485 Certificate
• Device Master File (DMF)
• Plant Master File (PMF)
• Power of Attorney

Step 4: Submit Form MD-14

Fill out the application form and upload documents.

Step 5: CDSCO Review

Authorities review your application and may request clarification.

Step 6: Receive MD-15 License

Once approved, CDSCO issues Form MD-15.

Documents Required for MD-14

To ensure quick approval, keep these documents ready:

• Manufacturer details
• Product specifications
• Quality certificates
• Labeling details
• Regulatory approvals from other countries

Cost of MD-14 and MD-15 License

The cost depends on:

• Type and class of device
• Number of products
• Government fees
• Consultancy charges

Higher-risk devices may require higher fees and more documentation.

Compliance After Getting MD-15 License

After receiving the license, you must follow:

• Proper labeling and packaging rules
• Maintenance of records
• Reporting of adverse events
• Regular compliance checks

This ensures long-term approval and avoids penalties.

Common Challenges Faced by Importers

Many businesses face issues such as:

• Incorrect device classification
• Incomplete documentation
• Delays in approval
• Lack of regulatory knowledge

Working with experts can help avoid these problems.

Benefits of MD-14 & MD-15 Import License

Obtaining the license offers:

• Legal entry into Indian market
• Increased business credibility
• Access to healthcare sector
• Growth opportunities

Conclusion

EVTL India is one of the leading BIS Consultant in India, helping manufacturers obtain their BIS licences hassle-free.

The MD-14 and MD-15 Import License is a crucial requirement for importing medical devices into India. By applying through the CDSCO portal, submitting Form MD-14, and obtaining Form MD-15, businesses can operate legally and expand in the Indian market.

Following the Medical Device As Per MDR 2017 ensures compliance, safety, and smooth business growth.