CDSCO License for Brachytherapy system chair

CDSCO License for Brachytherapy System Chair: Comprehensive Regulatory Guide for Class B Medical Devices

Introduction to Brachytherapy System Chair and Regulatory Importance

The Brachytherapy system chair is an essential radiotherapy device designed specifically to support and position patients during brachytherapy radiation treatments. Powered by mains electricity, it serves as a critical component for both manual applicator and remote after-loading brachytherapy systems. Given its medical significance and patient contact, regulatory compliance under the Central Drugs Standard Control Organisation (CDSCO) is mandatory before manufacturing or importing this device in India.

As a Class B medical device, the brachytherapy system chair falls under a moderate risk category, requiring a well-defined regulatory pathway to ensure safety, quality, and performance. Navigating the CDSCO licensing landscape can be challenging without expert knowledge. With over 25 years of experience and having assisted more than 500 companies, we provide you with practical steps, detailed timelines, cost breakdowns, and documentation guidance for a smooth and successful licensing process.

CDSCO Regulatory Framework for Brachytherapy System Chair

Under the Medical Device Rules (MDR) 2017, the brachytherapy system chair is classified as a Class B device, which mandates obtaining the MD5 manufacturing license from the State Licensing Authority. This licensing involves multiple stages including test license acquisition, product testing by government-approved laboratories, quality audits by notified bodies, and final approval by CDSCO.

The device is notified under File No. 29/Misc./03/2020-DC (180) dated 6.8.2021, formalizing its classification and regulatory requirements.

Risk Classification and License Requirements for Class B Devices

The classification of the brachytherapy system chair as Class B indicates a low to moderate risk device. This classification impacts licensing as follows:

• License Type: MD5 Manufacturing License (Application Form MD3)
• Issuing Authority: State Licensing Authority
• Key Requirements: Test license (MD13), product testing from government-approved labs, audit by notified bodies

For comprehensive classification details and risk management best practices, consult the Medical Device Classification and Risk Management guides.

Manufacturing License Process (MD5) for Brachytherapy System Chair

1. Test License (Form MD13): Begin by applying for a test license, which permits initial manufacturing and sample production for testing.
2. Product Testing: Submit samples to CDSCO-approved testing laboratories for compliance evaluation.
3. Document Preparation: Compile all necessary technical, quality, and safety documents.
4. License Application (Form MD3): Submit the manufacturing license application via the CDSCO MD Online Portal.
5. Audit: Undergo audit by a notified body listed on the Notified Bodies List.
6. Queries Resolution: Address any queries or observations raised by the department or notified body.
7. License Grant: Upon satisfaction, receive the MD5 manufacturing license.

Manufacturing License Documents Required for Class B Devices

To ensure a hassle-free application, prepare the following documents:

• Company Constitution (e.g., Memorandum and Articles of Association)
• Proof of Ownership or Lease of Manufacturing Premises
• Details and Qualifications of Technical Staff
• Fire Safety NOC
• Pollution Control NOC
• Device Master File (DMF): Detailed device specifications and design (Device Master File Guide)
• Plant Master File (PMF): Information about manufacturing facility and processes (Plant Master File Guide)
• Essential Principles Compliance Checklist
• Risk Management File
• Test Reports from certified labs (Testing Laboratories)
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) Documents, ideally ISO 13485 compliant

Import License Process (MD15) for Brachytherapy System Chair

If you intend to import the brachytherapy system chair rather than manufacture locally, an MD15 import license from the Central Licensing Authority is mandatory. The process involves:

1. Document preparation including manufacturing license, Free Sale Certificate, ISO 13485 certification, CE certificate, DMF and PMF.
2. Application submission on the CDSCO MD Online Portal.
3. Resolution of any queries raised by CDSCO.
4. License issuance.

For detailed guidance, refer to our Import License Guide.

Import License Documents Required

• Manufacturing License of the foreign manufacturer
• Free Sale Certificate from country of origin
• ISO 13485:2016 Certificate
• CE Certificate (if applicable)
• Device Master File
• Plant Master File
• Wholesale License (if applicable)
• Company Constitution

Timeline and Processing Duration

For the brachytherapy system chair (Class B), expect the following timelines:

• Test License (MD13): Approximately 1.5 to 2 months
• Product Testing: 4 to 6 weeks depending on lab workload
• Document Preparation: Concurrent with testing, typically 1 month
• Audit by Notified Body: Scheduled within 2 to 3 weeks post-application
• Queries Resolution: 2 to 4 weeks
• Final License Grant (MD5): Total ~3 to 4 months from test license application

Import licenses (MD15) generally take 5 to 6 months due to centralized review.

Government Fees and Costs

• MD5 Manufacturing License:
  • Application Fee: ₹5,000
  • Per Product Fee: ₹500
• Test License (MD13): Included in MD5 process fees

Additional costs include:

• Product testing fees at government-approved labs (varies by device complexity)
• Audit fees charged by notified bodies (typically ₹50,000 to ₹1,00,000 depending on scope)
• Consultancy fees if professional support is engaged

For a detailed breakdown, consult our MD5 License Guide.

Common Challenges and Solutions

• Incomplete Documentation: Ensure all required files are complete and formatted as per CDSCO guidelines. Use checklists to avoid omissions.
• Delayed Testing: Book testing slots early with government-approved labs to minimize waiting times.
• Audit Non-compliance: Prepare your facility thoroughly for notified body audits with mock inspections and internal audits.
• Query Management: Respond promptly and comprehensively to CDSCO and notified body queries to prevent delays.

Expert Consultation and Support

Given the complexities of medical device regulations, expert consultancy can significantly enhance your success rate. We provide end-to-end support from documentation, submission, audit liaison, to query resolution. Our experience with 500+ successful CDSCO license approvals positions us as your trusted partner.

Getting Started with Your CDSCO License Application for Brachytherapy System Chair

1. Assess Classification & Requirements: Confirm your device classification using official CDSCO resources.
2. Engage a Testing Laboratory: Identify and coordinate with government-approved labs early (Testing Laboratories).
3. Prepare Documentation: Start compiling your Device Master File, Plant Master File, and QMS documents.
4. Apply for Test License: Submit Form MD13 through the CDSCO MD Online Portal to initiate manufacturing samples for testing.
5. Plan for Audit: Schedule and prepare for notified body audit by reviewing the Notified Bodies List.
6. Submit Manufacturing License Application: After successful testing and audit preparation, apply for the MD5 license via Form MD3.
7. Monitor and Respond: Actively follow up on application status and resolve any queries promptly.

Embarking on your CDSCO licensing journey with structured planning and expert guidance will position your brachytherapy system chair for timely market entry in India, ensuring patient safety and regulatory compliance. Reach out to our expert consultants today to initiate your CDSCO license application with confidence.