CDSCO License for Stereotactic radiosurgical system

Comprehensive Guide to CDSCO Licensing for Stereotactic Radiosurgical Systems (Class D Medical Device)

As a leading regulatory consultancy with over 25 years of experience and having supported more than 500 companies in securing CDSCO licenses, we understand the complexity and critical importance of complying with Indian medical device regulations. The stereotactic radiosurgical system is a sophisticated Class D device used primarily in neurological applications to deliver precisely targeted therapeutic radiation doses for tumours in the brain, neck, breast, and spinal regions. Due to its high-risk classification and complexity, obtaining a CDSCO MD9 manufacturing license is a meticulous process that mandates adherence to stringent regulatory requirements.

CDSCO Regulatory Framework for Stereotactic Radiosurgical Systems

The Central Drugs Standard Control Organization (CDSCO) governs the import and manufacture of medical devices in India. For high-risk devices like the stereotactic radiosurgical system, the licensing authority is the Central Licensing Authority (CLA). The device falls under Class D as per the Medical Device Rules 2017 notification 29/Misc/03/2020-DC (201) dated 27.09.2021, which requires an MD9 license (application form MD7) for manufacturing and MD15 license for import.

Risk Classification and License Requirements

• Device Risk Class: D (High risk)
• Regulatory Route: MD9 Manufacturing License
• Governing Authority: CDSCO Central Licensing Authority
• License Form: MD7 for manufacturing, MD15 for import

This classification reflects the device’s significant potential impact on patient safety, necessitating robust quality systems, extensive documentation, and comprehensive audits.

Manufacturing License Process (MD9) for Stereotactic Radiosurgical Systems

The process for obtaining an MD9 license can be summarized in the following steps:

1. Test License Application (Form MD13): Initiate by applying for a test license, which allows you to manufacture samples exclusively for testing and validation.
2. Product Testing: Conduct mandatory testing at government-approved laboratories to verify compliance with Indian standards and essential principles.
3. Document Preparation: Compile comprehensive technical and quality documentation, including Device Master File (DMF), Plant Master File (PMF), Risk Management File, and others.
4. License Application Submission: Submit the manufacturing license application on Form MD7 via the CDSCO MD Online Portal.
5. Audit & Inspection: Facilitate a detailed audit and inspection by CDSCO officials to verify compliance with Good Manufacturing Practices (GMP) and regulatory standards.
6. Query Resolution: Promptly address any queries or deficiencies raised during the inspection.
7. License Grant: Upon satisfactory compliance, receive the manufacturing license (Form MD9).

Manufacturing License Documents Required

The documentation for a Class D device like the stereotactic radiosurgical system is extensive and must be meticulously prepared:

• Company Constitution (Incorporation Certificate, MOA/AOA)
• Proof of ownership or lease of manufacturing premises
• Qualification documents of technical and managerial staff
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF): Detailed device description, design, manufacturing process, and controls. Our Device Master File guide offers valuable insights.
• Plant Master File (PMF): Overview of manufacturing facility, equipment, and quality systems. Refer to our Plant Master File guide for best practices.
• Essential Principles Checklist demonstrating conformity with Indian regulations
• Risk Management File aligned with ISO 14971 standards; see our Risk Management resource
• Test Reports from CDSCO-approved laboratories (Testing Laboratories List)
• Product labels and Instructions for Use (IFU)
• Quality Management System (QMS) documents, typically ISO 13485:2016 certified

Import License Process (MD15) for Stereotactic Radiosurgical Systems

For importers of this Class D device, the process includes:

• Document Preparation: Gather all requisite certificates such as manufacturing license, Free Sale Certificate from the country of origin, ISO 13485:2016, CE certification, DMF, PMF, and wholesale license.
• Form MD14 Submission: Apply for the import license via Form MD14 on the CDSCO MD Online Portal.
• Query Resolution: Respond to any departmental queries expediently.
• License Issuance: Grant of MD15 import license by the central authority.

Import License Documents Required

• Valid manufacturing license from the exporting country
• Free Sale Certificate (FSC)
• ISO 13485:2016 and CE Certificate
• Device Master File and Plant Master File
• Wholesale license for distribution
• Company Constitution or registration documents

Timeline and Processing Duration

For import licenses (MD15), the overall process typically takes about 5-6 months.

Government Fees and Costs

• MD9 Manufacturing License: ₹50,000 per application plus ₹1,000 per product
• Test License (MD13): Separate fee as applicable
• Import License (MD15): Variable based on device class; for Class D, approximately $3,000 per site and$1,500 per product

These fees are exclusive of costs related to product testing, audit facilitation, and documentation consultancy.

Common Challenges and Solutions

• Document Gaps: Many applicants overlook critical documents such as Risk Management Files or incorrectly formatted Device Master Files. Engage with experts early to avoid rejections.
• Delays in Testing: Testing at government-approved labs can bottleneck the process; scheduling tests well in advance is crucial.
• Audit Non-Compliance: Facilities often lack adequate GMP implementation. Conduct pre-audit internal assessments and staff training.
• Query Management: Slow or incomplete responses to CDSCO queries prolong timelines. Assign a dedicated regulatory liaison for prompt communication.

Expert Consultation and Support

Navigating the CDSCO licensing pathway for a Class D stereotactic radiosurgical system requires specialized knowledge and experience. Our team provides end-to-end support—from initial documentation to audit preparation and liaison with CDSCO officials. We also assist in preparing the Device Master File and Plant Master File, ensuring alignment with CDSCO expectations.

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm your device class through the Medical Device Classification resource.
2. Prepare Initial Documentation: Begin compiling core documents such as company constitution, premises proof, and technical staff qualifications.
3. Apply for Test License: Submit Form MD13 on the CDSCO MD Online Portal to commence manufacturing of samples for testing.
4. Plan Product Testing: Coordinate with CDSCO-approved testing laboratories early to avoid delays.
5. Develop Comprehensive DMF and PMF: Utilize our detailed guides to create compliant master files.
6. Maintain Quality Systems: Ensure ISO 13485:2016 certification and robust QMS implementation.
7. Submit MD9 License Application: Once testing and document preparation are complete, file your application via the online portal.
8. Prepare for Audit: Conduct mock audits and staff training to ensure smooth CDSCO inspection.

By following these strategic steps and leveraging our regulatory expertise, manufacturers and importers of stereotactic radiosurgical systems can successfully obtain CDSCO licensing and enter the Indian market with confidence.

For tailored assistance, feel free to contact our consultancy—we are committed to guiding you through every regulatory milestone with clarity and efficiency.