MD15 License in India – Gateway to Import Medical Devices

The Indian medical device industry is growing rapidly, and with it comes the demand for imported medical devices. To ensure safety, quality, and compliance, the Central Drugs Standard Control Organisation (CDSCO) has made it mandatory for importers to obtain an MD15 License before bringing medical devices into India.

The MD15 License is essentially a regulatory approval under the Medical Device Rules, 2017, and is a key requirement for businesses engaged in the import of medical devices. Without this license, importers cannot legally distribute or sell medical devices in the Indian market.

What is MD15 License?

The MD15 License is a certificate issued by the CDSCO under the Drugs and Cosmetics Act, 1940, read with the Medical Device Rules, 2017. It authorizes companies to import, distribute, and sell medical devices in India. This license applies to a wide range of medical devices such as diagnostic equipment, surgical instruments, implantable devices, imaging systems, and other regulated products. It ensures that imported devices comply with Indian safety and quality standards, thereby protecting end-users and patients.

Who Needs an MD15 License?

Any business or individual involved in the import of medical devices into India requires an MD15 License. This includes:

✔ Medical device importers and distributors.

✔ Companies importing devices for resale.

✔ Multinational companies establishing a presence in India.

✔ Hospitals or institutions directly importing specialized devices.

Whether you are a startup in the healthcare sector or an established distributor, the MD15 License is mandatory for legal compliance.

Eligibility and Requirements for MD15 License

Before applying for an MD15 License, applicants must meet certain criteria. The company should be registered in India and must have an authorized Indian agent if the manufacturer is based outside India. Additionally, importers must appoint a competent technical staff with relevant qualifications in biomedical, pharmaceutical, or life sciences.

The following documents are generally required:

✔ Covering letter and application form.

✔ Manufacturing license or free sale certificate from the country of origin.

✔ ISO 13485 certificate of the manufacturer.

✔ Product description, intended use, and regulatory approvals.

✔ Power of attorney (in case of foreign manufacturers).

✔ Plant master file and device master file.

✔ Authorization letter of Indian agent.

Step-by-Step Process to Obtain MD15 License

Applying for an MD15 License involves a series of steps through the SUGAM online portal managed by CDSCO.

★Create Login Credentials – Register the company on the CDSCO SUGAM portal.

★ Prepare Documents – Collect all necessary certificates, regulatory approvals, and product details.

★ Submit Application – File Form MD-14 with all required documents through the portal.

★ Pay Prescribed Fees – Fees vary based on the type of medical devices being imported.

★ CDSCO Review – The CDSCO examines the application and may seek clarifications.

★ Grant of License – Upon approval, the authority issues the MD15 License.

★ The process usually takes 6–9 months, depending on the completeness of documents and the complexity of the devices.

Validity and Renewal of MD15 License

The MD15 License is valid for five years, unless suspended or cancelled by the licensing authority. Importers must apply for renewal at least nine months before expiry. The renewal process is similar to the initial application and requires updated documents and compliance records.

Benefits of Obtaining MD15 License

Getting an MD15 License offers several advantages to businesses:

◆ Legal Authorization to import and sell medical devices in India.

◆ Market Access to India’s growing healthcare and medical device industry.

◆ Credibility & Trust among hospitals, distributors, and healthcare professionals.

◆ Regulatory Compliance with Indian laws, avoiding penalties or confiscation.

◆ Global Recognition since compliance with Indian regulations strengthens the company’s international reputation.

Common Challenges in MD15 License Application

Many importers face issues during the application process. Common challenges include:

● Delays due to incomplete documentation.

● Rejection caused by non-compliance with technical standards

● Difficulty in obtaining regulatory approvals from the country of origin.

● Lack of proper coordination with Indian agents.

This is why it is advisable to seek professional assistance for a smooth application process.

How PSR Compliance Helps You with MD15 License

Obtaining an MD15 License is a technical and time-consuming process. At PSR Compliance, we simplify the journey by offering end-to-end support. Our services include:

✅Consultation on eligibility and documentation.

✅Preparation and filing of Form MD-14 application.

✅Coordination with CDSCO for queries and clarifications.

✅Assistance in renewal and post-approval compliance.

With our expertise, you can ensure timely approval and avoid unnecessary delays, allowing you to focus on business growth while we handle compliance.

Frequently Asked Questions (FAQ)

What is the MD15 License?

It is a license issued by CDSCO that allows the import and sale of medical devices in India.

Who issues the MD15 License?

The Central Drugs Standard Control Organisation (CDSCO) is the licensing authority.

How long is the MD15 License valid?

The license is valid for five years, subject to renewal.

Can a foreign manufacturer apply directly for MD15 License?

No, they must appoint an authorized Indian agent to apply on their behalf.