MD-15 License Import Medical Device

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✔Ensuring smooth and continuous adherence to all legal requirements.

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Benefits of MD-15 Import License

✔Legal Import Authorization for Medical Devices in India
✔Regulatory Compliance with CDSCO Norms
✔Access to Indian Healthcare Market and Distribution Networks
✔Improved Business Credibility Among Buyers and Authorities
✔Eligibility for Public Sector Contracts and Institutional Supply

Applicability

MD-15 Import License is required for:

✔Foreign manufacturers importing medical devices into India
✔Indian importers and authorized agents for global device brands
✔Companies importing diagnostic, surgical, or therapeutic devices
✔Entities requiring CDSCO Form MD-15 for market authorization
✔Businesses setting up authorized agent representation in India

Licensing Process

Regulatory Classification of Device

Confirm device classification (A, B, C, or D) based on CDSCO guidelines.

Document Preparation

Compile DMF, PMF, legal, and technical documents for submission.

Application Filing on SUGAM Portal

Form MD-14 is submitted via CDSCO's SUGAM portal along with the prescribed fee.

CDSCO Review & Queries

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

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