Manufacturing License (MD-9): Class C & D
Manufacturing License Form MD-9, issued by CDSCO under the Medical Devices Rules, 2017, is required for manufacturing Class C and D medical devices in India. The application submitted through Form MD-7 and includes assessment of the manufacturing facility, Quality Management System (QMS), and technical documentation. This License authorises the manufacture and sale of higher-risk medical devices while demonstrating compliance with CDSCO requirements and ISO 13485-aligned with quality standards. It also supports regulatory compliance and smooth market access in India.
When Do You Need CLA Support
and What Are the Key Challenges?
Support for manufacturers preparing to commercialize Class C and D medical devices under the Medical Devices Rules, 2017.
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For Class C or D devices under Medical Devices Rules, 2017
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Before manufacturing, assembling, or processing moderate to high-risk devices
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Prior to sale, distribution, or commercialization in India
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When establishing a new manufacturing facility for Class C & D devices
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When adding new Class C or D products to an existing license
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To comply with CDSCO regulations and ISO 13485 standards
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When applying for Central Licensing Approval (CLA) under CDSCO
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Regulatory Complexity
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Incorrect Classification
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Documentation Errors
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GMP & Infrastructure Requirements
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Regulatory Queries & Delays
Our Approach and What You Will Get
End-to-end support for Class C and D medical device manufacturers seeking fast, compliant, and hassle-free approvals under CDSCO.
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Device classification and regulatory strategy under CDSCO
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Gap analysis and technical documentation (DMF, PMF) preparation
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Complete application filing and coordination with Central Licensing Authority and CDSCO regulatory teams
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GMP compliance, ISO 13485 implementation, and facility readiness
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Query management, audit support, and approval assistance
When you partner with us for your Manufacturing License (MD-9) for Class C & D medical devices, you receive end-to-end regulatory support designed to deliver fast, compliant, and hassle-free approvals under the Central Drugs Standard Control Organization framework.
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Complete MD-9 Licensing Support (Class C & D)
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Accurate Technical Documentation & Dossier Preparation (DMF, PMF, CER, etc.)
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Efficient regulatory execution and smoother approval process
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GMP & ISO 13485 Facility Compliance Guidance
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Dedicated Regulatory & Technical Expertise
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End-to-End Coordination with CDSCO & Stakeholders
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Post-License Compliance Support
Why Choose Tacit Medtek and Case Example
Reliable support for Class C and D medical device licensing, technical documentation, and CDSCO coordination.
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Expertise in CDSCO regulations for Class C & D devices
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Specialized support for Manufacturing License (MD-9) approval
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Complete guidance on documentation, application, and compliance
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Focused on minimizing delays and approval issues
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Assistance with technical file review and gap assessment
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Timely coordination and professional support
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Commitment to quality, accuracy, and compliance
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Reliable support to streamline regulatory approvals
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Dedicated to a smooth and hassle-free MD-9 licensing process
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Challenge: A medical device company aimed to manufacture a Class C device in India but was unclear about regulatory requirements, documentation, and CDSCO approval procedures. They also faced challenges in aligning their facility and quality systems with regulatory expectations.
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Our Approach: Verified device classification and regulatory pathway under MDR 2017. Conducted gap analysis of manufacturing facility and ISO 13485 QMS. Prepared complete MD-9 application with technical documents, Plant and Device Master Files. Coordinated with Notified Body for audit preparation and inspection support. Managed CDSCO submission and resolved queries efficiently.
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Outcome: The client successfully obtained the MD-9 Manufacturing License within 4 to 5 months, enabling compliant manufacturing and timely market entry for the Class C medical device in India.
FAQ
Frequently Asked Questions
For Class C and Class D medical devices, CDSCO generally conducts inspection activities after preliminary review of the submitted application and supporting documents. Actual timelines may vary depending on application completeness and regulatory workload.
Medical devices in India are classified according to risk levels defined under the Medical Devices Rules, 2017. Devices are categorized as Class A, B, C, or D based on intended use, invasiveness, duration of use, and associated patient risk.
Manufacturers may refer to CDSCO guidance documents and risk-based classification lists published on the official CDSCO website for device categorization references.
Medical device classification is regulated under the Medical Devices Rules, 2017 and overseen by CDSCO based on prescribed risk classification principles.
Yes. Manufacturing facilities for applicable Class C and Class D medical devices are generally subject to inspection or audit before licence approval under MDR 2017.
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