What Is MD15 License in CDSCO for Medical Devices?

The MD15 license is the official import license issued by CDSCO that allows a company to import medical devices into India. Under the Medical Device Rules, 2017, any importer or foreign manufacturer must obtain this license before selling or distributing medical devices in the Indian market.

The Central Drugs Standard Control Organization (CDSCO) grants the MD15 license after reviewing the MD14 application, which includes regulatory documentation, device classification, and compliance verification.

The MD15 license confirms that:
The medical device meets CDSCO regulatory requirements
The manufacturer complies with quality standards such as ISO 13485
The device is approved for import and distribution in India

Before obtaining MD15, applicants must prepare all required documents for medical device import, including Power of Attorney, Device Master File, Plant Master File, Free Sale Certificate, and labeling compliance.

Additionally, foreign manufacturers must appoint an Indian Authorized Agent who submits the application and communicates with CDSCO during the review process.

Because MD15 approval depends on proper documentation and classification, companies often work with regulatory experts. Businesses planning to import medical devices into India can explore professional medical device import services in India offered by Regacats Solutions to ensure compliance and faster approval.

To understand the complete process from application to approval, applicants should also review the detailed medical device import license guide explaining MD14 submission, documentation, and CDSCO approval workflow.