MD-9 License for Class-C and D
The MD-9 License is issued by the Central Drugs Standard Control Organization (CDSCO) for the import of Class C and Class D medical devices into India. These classes cover high to very high-risk medical devices, such as cardiac stents, orthopedic implants, ventilators, pacemakers, and diagnostic imaging equipment.
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Benefits
Legal Authorization for Import
Legally import and market Class C & D medical devices across India.Access to Indian Market
Tap into India’s growing demand for high-risk medical devices in hospitals and healthcare institutions.Avoid Regulatory Penalties
Stay compliant with CDSCO norms to prevent fines, product seizures, or legal issues.Trusted Brand Image
Increase buyer and healthcare provider confidence with certified and regulated products.Eligibility for Government Tenders
Participate in procurement through platforms like GeM and e-marketplaces.
Process
Product Classification & Compliance Review
We identify device classification (C or D) and check for regulatory readiness.Preparation of Device Master File (DMF) & Plant Master File (PMF)
Our experts help you align with CDSCO documentation standards.Appointment of Indian Authorized Agent
If required, we assist foreign manufacturers with identifying or registering an Indian agent.Application Filing via SUGAM Portal
We submit the MD-6 application for Form MD-9 to CDSCO along with technical and legal documentation.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 & Packaging Artwork
What You’ll Get
End-to-End Support for MD-9 Import Licensing
Global Experience in CDSCO Compliance
Fast Turnaround Time & Documentation Accuracy
Assistance with Authorized Agent Setup
Post-License Import Compliance Guidance
Frequently Asked Questions
It is required for importing high-risk medical devices (Class C & D) into India.
The manufacturer’s authorized agent in India must apply for the license.
The license is valid perpetually, with retention fees due every 5 years.
Yes, approval from a recognized regulatory body in the country of origin is generally required.
Yes, provided all products are listed and covered in the application.
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