If you are planning to import and distribute medical devices in India, obtaining the MD-14 License is a mandatory step under the Medical Devices Rules, 2017. This license is issued by the Central Drugs Standard Control Organization (CDSCO) and allows businesses to legally import medical devices for wholesale distribution in the Indian market.

What is MD-14 License?

The MD-14 License is an application form used to apply for an import license for medical devices. Once approved, the authority issues the MD-15 License, which is the final permission required to import and sell products in India.

How to Apply for MD-14 License

To apply for an import wholesale license in India, follow these steps:

• Register on CDSCO SUGAM Portal
  Create an account and select the appropriate application type.
• Prepare Required Documents
  • ISO 13485 Certificate
  • Free Sale Certificate from the country of origin
  • Device Master File (DMF)
  • Plant Master File (PMF)
  • Power of Attorney (for authorized Indian agent)
• Submit MD-14 Application
  Fill in all product and manufacturer details accurately.
• Pay Government Fees
  Fees vary depending on the number and class of devices.
• Approval & MD-15 License Issuance
  After review, CDSCO grants approval and issues the MD-15 License.

Import Wholesale License Benefits

• Legal authorization to import and distribute medical devices
• Access to the growing Indian healthcare market
• Builds trust with hospitals and distributors
• Ensures compliance with CDSCO regulations

If you want to start an import wholesale business for medical devices in India, applying for the MD-14 License is essential. Proper documentation and expert guidance can help you get faster CDSCO approval without delays.