CDSCO License for Radiation therapy beam-shaping block

Comprehensive Guide to CDSCO Licensing for Radiation Therapy Beam-Shaping Blocks (Class C Medical Device)

Radiation therapy beam-shaping blocks are critical devices used in oncology to precisely modify the shape of radiation beams, ensuring targeted treatment with minimal damage to surrounding tissues. Made from highly attenuating materials like lead, these devices fall under the radiotherapy category and are classified as Class C medical devices by the Central Drugs Standard Control Organization (CDSCO) in India. Given their direct impact on patient safety and treatment efficacy, obtaining the correct CDSCO licensing is mandatory for manufacturers and importers aiming to market these devices in India.

CDSCO Regulatory Framework for Radiation Therapy Beam-Shaping Blocks

The CDSCO regulates medical devices in India under the Medical Device Rules (MDR) 2017. Radiation therapy beam-shaping blocks are notified under File No. 29/Misc./03/2020-DC (180) dated 6.8.2021 and fall into the Class C risk category, which involves moderate-to-high risk.

Class C devices require a centralized licensing process managed by the CDSCO’s Central Licensing Authority, ensuring stringent evaluation of safety, quality, and performance.

Risk Classification and License Requirements for Class C Devices

Class C devices like radiation therapy beam-shaping blocks are considered to have moderate to high risk due to their critical role in clinical outcomes. Hence, they necessitate an MD9 manufacturing license for domestic production and an MD15 import license for imported products.

• MD9 License: For manufacturers producing Class C devices in India.
• MD15 License: For importers wishing to bring these devices into India.

Manufacturing License Process (MD9) for Radiation Therapy Beam-Shaping Blocks

Our extensive experience with over 500 companies shows that the MD9 license process for Class C devices typically spans 4 to 5 months. It involves multiple steps:

1. Test License Acquisition (Form MD13): Issued by CDSCO, this preliminary license allows initial testing and takes approximately 1.5 to 2 months.
2. Product Testing: Testing must be carried out at CDSCO-approved labs to verify device compliance with safety and performance standards. You can find a list of CDSCO-approved testing laboratories.
3. Document Preparation: Compilation of a comprehensive dossier including Device Master File, Plant Master File, Risk Management File, Essential Principles Checklist, and Quality Management System (QMS) documents.
4. License Application (Form MD7): Submission of the manufacturing license application through the CDSCO MD Online Portal.
5. Audit by CDSCO Inspectors: A detailed site audit is conducted to verify compliance with MDR 2017 and QMS requirements.
6. Query Resolution: Addressing any queries raised by the CDSCO or auditors promptly to avoid delays.
7. License Granting (Form MD9): Upon satisfactory review, the manufacturing license is issued.

Manufacturing License Documents Required for MD9

For radiation therapy beam-shaping blocks (Class C), the documentation package is comprehensive and includes:

• Company Constitution Documents (Incorporation Certificate, Memorandum and Articles of Association)
• Proof of Ownership or Lease of Manufacturing Premises
• Qualification and Experience Details of Technical Personnel
• Fire Safety and Pollution Control NOCs
• Device Master File detailing design, specifications, and manufacturing process (Device Master File Guide)
• Plant Master File outlining manufacturing facility and equipment (Plant Master File Guide)
• Essential Principles Compliance Checklist
• Risk Management File demonstrating hazard analysis and mitigation (Risk Management)
• Test Reports from CDSCO-approved labs
• Product Labels and Instructions for Use (IFU)
• Quality Management System Documentation (preferably ISO 13485:2016 certified)

Import License Process (MD15) for Radiation Therapy Beam-Shaping Blocks

The import licensing process for Class C devices like beam-shaping blocks requires submission of an MD15 license application to the CDSCO Central Licensing Authority. The process typically takes 5 to 6 months and includes:

1. Document Compilation: Including manufacturing license from the country of origin, Free Sale Certificate, and quality certifications.
2. Application Submission (Form MD14): Lodged via the CDSCO MD Online Portal.
3. Review and Query Resolution: Responding to any regulatory queries.
4. License Granting (Form MD15): Final approval to import the device into India.

Import License Documents Required

• Valid Manufacturing License from the country of origin
• Free Sale Certificate
• ISO 13485:2016 Certificate
• CE Certificate or equivalent international standard
• Device Master File
• Plant Master File
• Wholesale License if applicable
• Company Constitution Documents

Timeline and Processing Duration

Government Fees and Costs

• MD9 License for Class C devices: ₹50,000 per application + ₹1,000 per product
• MD15 Import License for Class C devices: Approximately ₹3,000 per site + ₹1,500 per product (converted from USD rates)

Note: Test license on Form MD13 for manufacturing requires additional fees and testing costs, varying based on product complexity.

Common Challenges and Solutions

• Delayed Test Reports: Partner with CDSCO-approved testing laboratories early to schedule testing and avoid bottlenecks.
• Incomplete Documentation: Utilize comprehensive templates for Device Master Files and Plant Master Files to ensure completeness.
• Audit Non-compliance: Prepare thoroughly for CDSCO inspections by maintaining ISO 13485 QMS and internal audit records.
• Query Delays: Assign dedicated regulatory personnel to address CDSCO queries promptly, reducing turnaround times.

Expert Consultation and Support

Having supported over 500 medical device companies, we understand the intricacies involved in obtaining CDSCO licenses for Class C devices like radiation therapy beam-shaping blocks. Our expert regulatory consultants can assist with:

• Gap analysis of your current compliance status
• Preparation and review of licensing documentation
• Liaison with CDSCO and notified bodies
• Scheduling and preparing for audits
• Post-approval compliance and vigilance

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm your radiation therapy beam-shaping block is Class C by reviewing the Medical Device Classification.
2. Engage a CDSCO-Approved Testing Laboratory: Early engagement helps streamline the testing phase.
3. Prepare Your Documentation: Use our detailed Device Master File Guide and Plant Master File Guide to compile your dossier.
4. Submit Test License Application (Form MD13): Initiate the process on the CDSCO MD Online Portal.
5. Plan for Audit and Training: Ensure your team is well-trained on QMS and regulatory requirements in preparation for CDSCO inspections.

By following these steps and leveraging our expert guidance, manufacturers and importers can navigate the complex regulatory landscape efficiently, ensuring a successful market entry for radiation therapy beam-shaping blocks in India.