MD-9 License Class-C and D

Experience a seamless, hassle-free & timely registration with our expert consultants.

✔Our in-house team handles over 50 types of business licenses.
✔We provide end-to-end services across India.
✔Ensuring smooth and continuous adherence to all legal requirements.

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Applicability

MD-9 License is required for:

✔Foreign manufacturers seeking to import high-risk medical devices into India
✔Indian importers and distributors of Class C and D devices
✔Companies importing implants, diagnostic equipment, or life-support devices
✔Entities requiring CDSCO registration for market entry
✔Businesses needing Indian Authorized Agent setup for CDSCO compliance

Licensing Process

Product Classification & Compliance Review

Identify device classification (C or D) and check for regulatory readiness.

Preparation of DMF & PMF

Align Device Master File and Plant Master File with CDSCO documentation standards.

Appointment of Indian Authorized Agent

Assist foreign manufacturers with identifying or registering an Indian agent.

Application Filing via SUGAM Portal

Submit the MD-9 application along with technical and legal documentation to CDSCO.

Review & Approval

CDSCO reviews and issues the MD-9 License upon satisfactory verification.

Documents Required

✔Duly filled Form MD-6 Application
✔Valid Power of Attorney (POA)
✔ISO 13485 Certificate (of manufacturer)
✔Free Sale Certificate (from country of origin)
✔Device Master File (DMF)
✔Plant Master File (PMF)
✔CE/FDA Certification or equivalent approval
✔Undertaking of Regulatory Compliance
✔Details of Authorized Indian Agent
✔Copy of Importer's Wholesale Drug License
✔Instruction for Use (IFU), Labels and Packaging Artwork

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Founder, RS Enterprises

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Director, Mehta Foods Pvt. Ltd.

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CEO, Gupta Trading Co.

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