MD 15: CDSCO Medical Device Import License?

MD 15: CDSCO Medical Device Import License?

India’s medical device market is expanding. Global demand is shifting. Many companies now want to sell medical devices here. But entering this regulated market needs more than just product quality. If a foreign manufacturer decides to import medical devices to India, the law dictates they hold a license. This license is called the MD 15 Import License. It is issued by the Central Drugs Standard Control Organization (CDSCO). This license matters. Without it, no medical device importer may sell or distribute any regulated device in India.

The rules are strict. The procedure is detailed. But if you follow each step, you can get approval smoothly. Many businesses fail not because of quality issues, but due to lack of clarity in regulatory steps. This article explains the full process of getting an MD 15 CDSCO Import License. You will learn how the application works, who can apply, what documents are needed

What is the MD 15 Import License?

The MD 15 is a license granted by CDSCO. It allows a foreign manufacturer to import regulated medical devices into India. As per the Medical Devices Rules, 2017, all Class A, B, C, and D devices fall under regulation. If you are not based in India, you must apply for this license through a licensed Indian Agent. This agent holds the Form MD 14 license. It represents your business before the CDSCO.

Each MD 15 license is product-specific. This means one license is valid for one product or one group of similar devices. If your company imports different models, each model or group will require a separate license. That’s why it is important to plan the scope of your license carefully.

Who Needs the MD 15 License?

A foreign manufacturer must get an MD 15 license to sell medical devices in India. It does not matter whether you ship devices directly or through distributors. The Indian law treats every import the same. This rule applies to the following:

• Original Equipment Manufacturers (OEMs) of medical devices
• Brand owners who manufacture overseas
• Foreign suppliers or exporters of medical-grade instruments
• Companies supplying devices to Indian hospitals, labs, or clinics

Even if you manufacture a Class A (low-risk) device like a thermometer, you still need a license to import it. There are no exemptions for device risk class when it comes to import.

Read More Medical Device Import License

Step-by-Step Guide to Apply for MD 15 License

Let’s now understand the full application process.

Step 1: Appoint an Indian Agent

If your company is located outside India, you cannot apply for MD 15 directly. You must appoint an Indian Agent. This person or company must hold a Form MD 14 license, which allows them to represent you. They will act as the communication point between you and CDSCO.

To appoint an agent, you must submit a Power of Attorney (PoA). This document must be signed and notarized by the manufacturer. The PoA must clearly say that your Indian Agent has the right to file and follow up on the MD 15 application.

Step 2: Gather All Required Documents

Before filling out the online form, your company must gather these documents:

• Copy of valid manufacturing license issued in the country of origin
• Free Sale Certificate (FSC) issued by health authority of exporting country
• ISO 13485 Certificate (for Quality Management System)
• Device Master File (DMF), including device details, model numbers, specs, and labelling
• Plant Master File (PMF), with information about the facility
• Clinical evaluation reports and safety data
• Instructions for use (IFU) and device brochures
• CE Certificate, US FDA Approval, or equivalent (if applicable)
• Undertaking by the manufacturer
• Power of Attorney to the Indian Agent

Each document must be clear, updated, and submitted in English. Any translation must be certified.

Step 3: Register on the SUGAM Portal

The CDSCO handles all MD 15 license applications through its SUGAM Portal. It is an online platform where manufacturers and agents can apply and track applications. Your Indian Agent must first create a login. After the login is approved, they can access the MD 15 application form.

Step 4: Pay the Government Fees

The fee for an MD 15 license depends on the device category and the number of manufacturing sites. Usually, the fee is paid through Bharatkosh, an online government payment portal. The payment proof must be uploaded along with the application.

For example, for one site and one product, the basic fee is USD 1,000. If the product is

manufactured at multiple sites or if there are many models, the fees can increase.

Step 5: Submit the Application and Track Status

Once all details are filled, the application is submitted online through SUGAM. After submission, CDSCO checks the documents. If any document is missing or needs correction, the system will notify your agent.

Step 6: Grant of License (Form MD 15)

If all documents are correct and there are no issues, CDSCO will approve the license. The license is issued in Form MD 15. It includes your device name, manufacturer name, Indian Agent details, and manufacturing site address.

Read More Medical Device Manufacturing License

Conclusion

Getting an MD 15 Import License is the first legal step in bringing your medical device into India. It builds your credibility and gives you a compliant entry into a growing healthcare market. But the process is strict. Every step needs attention—from choosing the right agent to uploading the correct documents. You must follow the CDSCO rules to ensure your product reaches India legally and safely.

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