Import License for Predicate Medical Devices
(Forms MD-14, MD-15)
Secure the mandatory MD-15 import license to legally distribute and sell your medical devices across the Indian healthcare market.
Consult Our CDSCO Experts
What is an MD-15 License?
The MD-15 license is the official import license granted by the Central Drugs Standard Control Organization (CDSCO). It authorizes the importation of medical devices—spanning Classes A, B, C, and D—into India, enabling their legal commercialization and distribution.
To obtain this license, applicants must submit Form MD-14. The CDSCO has actively worked to simplify the importation system, creating a more streamlined pathway for compliant medical devices of all risk classes to enter the market.
Who Needs It?
Indian Importers
Companies based in India whose core operation is importing medical devices require this license.
Authorized Indian Agents
Foreign manufacturers must appoint a local Authorized Agent to act as their liaison with CDSCO and hold the MD-15 license on their behalf.
The MD-14 Application Process
Application via Form MD-14
The Authorized Agent submits the online MD-14 application on the CDSCO portal, detailing the device's generic name, intended use, risk class, and materials.
Document Upload
A comprehensive Device Master File is required, including product specifications, biocompatibility data, clinical evidence, QMS certificates, and Free Sale Certificates (FSC).
Fee Payment
Payment of the requisite government fees as stipulated in the Second Schedule of the Medical Device Rules, 2017.
CDSCO Review & Approval
The licensing authority rigorously reviews the technical dossier. Upon satisfaction, they issue the MD-15 import license.
Validity Note: The MD-15 license remains valid for 5 years from its date of issue, provided the mandatory retention fees are paid periodically to maintain its active status.
How We Can Help
- In-depth gap analysis of your Device Master File
- Seamless preparation and submission of Form MD-14
- Active liaison with CDSCO to expedite the review process
- Acting as your Authorized Indian Agent