MD-15 License for Import Medical Device
The MD-15 License is issued under the Medical Devices Rules, 2017 by the Central Drugs Standard Control Organization (CDSCO). It is required for the import of medical devices for sale or distribution in India. This license is granted in Form MD-15 after the submission of an application in Form MD-14 by the foreign manufacturer’s authorized Indian agent.
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Benefits
Legal Import Authorization
Allows foreign medical devices to be legally imported and marketed in India.Regulatory Compliance
Meet all CDSCO norms and avoid import delays, penalties, or product seizures.Access to Indian Healthcare Market
Reach hospitals, diagnostic centers, and government procurement programs.Improved Business Credibility
Gain trust among Indian buyers and regulatory authorities with licensed imports.Eligibility for Public Sector Contracts
Required for participating in government tenders and institutional supply.
Process
Regulatory Classification of Device
Confirm device classification (A, B, C, or D) based on CDSCO guidelines.Document Preparation
Our team assists in compiling DMF, PMF, legal, and technical documents.Application Filing on SUGAM Portal
Form MD-14 is submitted via CDSCO’s SUGAM portal along with the prescribed fee.CDSCO Review & Queries (if any)
CDSCO assesses the submission and may raise clarifications, which we help resolve promptly.Issuance of Form MD-15 License
Upon approval, CDSCO grants the MD-15 license to the Indian authorized agent.
Documents Required
Duly filled Form MD-14
Power of Attorney from the foreign manufacturer
ISO 13485 Certificate
Free Sale Certificate (FSC) or equivalent
Device Master File (DMF)
Plant Master File (PMF)
CE/FDA/Health Canada Certificate (if applicable)
Undertaking by the manufacturer
Product Labels, IFU, and Packaging Information
Details of Indian Authorized Agent
Importer’s Drug Wholesale License
What You’ll Get
Expertise in CDSCO Import Licensing
Support for Indian Authorized Agent Setup
Accuracy in Documentation and Timely Filing
Experience with Global Medical Device Manufacturers
Affordable, Transparent Pricing
Frequently Asked Questions
Only the authorized Indian agent of a foreign medical device manufacturer can apply.
Yes, it is mandatory for importing Class A, B, C, or D medical devices into India.
The license is valid perpetually with retention fees payable every five years.
Yes, the Indian agent must hold a valid Drug Wholesale License.
Yes, we handle the entire process—from classification to documentation, filing, and follow-ups.
What clients say
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