CDSCO License for Brachytherapy system remote after loading source safe

Comprehensive Guide to CDSCO Licensing for Brachytherapy System Remote After Loading Source Safe (Class C)

Introduction: Understanding the Device and Regulatory Importance

Brachytherapy System Remote After Loading Source Safe is a critical component in radiotherapy, designed to shield radioactive sources and protect operators, patients, and others from exposure. Given its complexity and the use of radioactive materials, this device falls under Class C as per CDSCO regulations, reflecting a moderate to high risk. Ensuring compliance with the Central Drugs Standard Control Organization (CDSCO) licensing framework is essential for manufacturers and importers to legally market and operate such devices in India. With over 25 years of experience assisting 500+ companies, we provide an expert roadmap for obtaining the necessary approvals for this device.

CDSCO Regulatory Framework for Radiotherapy Devices

Radiotherapy devices, especially those involving radioactive sources like the Brachytherapy System Remote After Loading Source Safe, are stringently regulated under India's medical device rules. CDSCO governs the licensing, approval, and post-market surveillance of such devices. The framework mandates compliance with quality, safety, and efficacy requirements, guided by the Medical Device Rules (MDR) 2017 and subsequent amendments.

Risk Classification and License Requirements for the Device

According to the CDSCO classification, the Brachytherapy System Remote After Loading Source Safe is categorized as a Class C device due to its involvement with radioactive materials and potential patient impact.

• Risk Class: C
• License Type: MD9 (Central Licensing Authority)
• Application Form: MD7

Class C devices require a more rigorous approval process involving product testing, document verification, and an on-site audit by CDSCO inspectors.

For a detailed understanding of medical device classification, refer to our Medical Device Classification guide.

Manufacturing License Process (MD9) for Class C Devices

The MD9 license is mandatory before manufacturing or assembling Class C devices in India. The process includes:

1. Test License (Form MD13): Apply for a test license to manufacture the device prototype for testing. This stage typically takes 1.5 to 2 months.
2. Product Testing: Conduct testing at government-approved laboratories to confirm compliance with Indian and international standards. Utilize the list of testing laboratories for accreditation.
3. Document Preparation: Compile comprehensive documentation, including Device Master File (DMF), Plant Master File (PMF), Essential Principles Checklist, Risk Management File, and Quality Management System (QMS) documents.
4. Application Submission: Submit the MD9 manufacturing license application using Form MD7 through the CDSCO MD Online Portal.
5. Audit by CDSCO Inspectors: Post document review, CDSCO schedules an audit of the manufacturing site.
6. Query Resolution: Address any observations or queries raised during the audit or by the CDSCO.
7. Grant of License: Upon satisfactory compliance, the MD9 license is granted on Form MD9.

For step-by-step guidance, our MD9 License Guide offers detailed insights.

Manufacturing License Documents Required

For the Brachytherapy System Remote After Loading Source Safe, the following documents are critical:

• Company Constitution and Incorporation Certificate
• Proof of Ownership or Lease Agreement of Manufacturing Premises
• Details and Qualification Certificates of Technical Staff
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF) detailing device design, specifications, and manufacturing processes. Learn more in our Device Master File guide.
• Plant Master File (PMF) describing manufacturing facilities and quality control. Refer to our Plant Master File guide.
• Essential Principles Checklist ensuring compliance with Indian safety norms
• Risk Management File as per ISO 14971 standards. See our Risk Management guide.
• Product Test Reports from CDSCO-approved laboratories
• Labeling and Instructions for Use (IFU)
• Quality Management System documentation (ISO 13485:2016 certification recommended)

Import License Process (MD15) for Brachytherapy Systems

If importing the device into India rather than manufacturing locally, an MD15 Import License is mandatory:

1. Document Preparation: Gather all technical, manufacturing, and quality documentation similar to the manufacturing license but also include Free Sale Certificate, CE Certificate, and ISO certification.
2. Application Submission: File the application using Form MD14 through the CDSCO MD Online Portal.
3. Queries and Clarifications: Be prepared for queries from CDSCO and provide timely responses.
4. License Grant: On satisfactory review, MD15 license is issued.

Documents required include:

• Valid Manufacturing License from the country of origin
• Free Sale Certificate
• ISO 13485:2016 Certification
• CE Certificate
• Device Master File and Plant Master File
• Wholesale Drug License
• Company Constitution

For more, check our Import License guide.

Timeline and Processing Duration

• Test License (MD13): 1.5 – 2 months
• Product Testing: 1 – 1.5 months (dependent on lab availability)
• MD9 License Application Processing: 2 – 3 months including audit and query resolution

Total Estimated Duration: Approximately 4 to 5 months

For the import license (MD15), the process generally takes 5 to 6 months.

Government Fees and Costs

• MD9 License Fee: Rs. 50,000 per application + Rs. 1,000 per product
• Test License Fee (MD13): Rs. 5,000 approx.
• Import License (MD15) Fee: For Class C devices, around $3,000 per site and$1,500 per product

Note that fees are subject to change as per CDSCO notifications. All applications and fee payments are processed online via the CDSCO MD Online Portal.

Common Challenges and Solutions

• Delayed Testing: Limited availability of government-approved testing labs can cause bottlenecks. Early booking and utilizing the list of testing laboratories can mitigate delays.
• Audit Non-Compliance: Inadequate documentation or facility readiness can lead to audit failures. Preparing a comprehensive Plant Master File and ensuring staff training is essential.
• Query Resolution Delays: Slow responses to CDSCO queries extend timelines. Assign dedicated regulatory personnel for prompt communication.
• Complex Documentation: For devices like brachytherapy systems, detailed risk management and essential principles documentation is critical. Use expert consultants to streamline this.

Expert Consultation and Support

Navigating CDSCO licensing for Class C brachytherapy devices demands expertise. Our 25+ years of experience and over 500 successful client projects enable us to offer:

• End-to-end application preparation
• Device Master File and Plant Master File creation
• Test license facilitation
• Liaison with notified bodies and CDSCO
• Audit readiness training

Engage with our consultants early to avoid costly delays and ensure compliance.

Getting Started with Your CDSCO License Application

1. Evaluate Device Classification: Confirm your device is Class C and identify the appropriate license type (MD9).
2. Prepare Documentation: Begin compiling your DMF, PMF, risk management files, and QMS documents.
3. Apply for Test License (MD13): Submit your initial manufacturing test license application via the CDSCO MD Online Portal.
4. Schedule Testing: Coordinate with accredited labs early to complete product testing within the timeline.
5. Plan for Audit: Prepare your facility and staff for the CDSCO audit by reviewing the list of notified bodies for audit partners.
6. Submit MD9 Application: Once testing is complete, apply for the MD9 license with full documentation.
7. Respond Promptly: Address any CDSCO queries without delay to keep the process on track.

Embarking on your CDSCO licensing journey with detailed planning and expert support can significantly reduce your time to market for this critical radiotherapy device. Contact us to leverage our regulatory expertise and ensure your Brachytherapy System Remote After Loading Source Safe gains timely approval in India.