CDSCO License for Central circulatory remote after loading brachytherapy  therapeutic radionuclide system

Comprehensive Guide to CDSCO Licensing for Central Circulatory Remote After Loading Brachytherapy Therapeutic Radionuclide System

Entering the Indian medical device market with a high-risk Class D device such as the Central Circulatory Remote After Loading Brachytherapy Therapeutic Radionuclide System demands a thorough understanding of the regulatory landscape. This device, designed to deliver precise radiation doses via a remotely controlled radiation source transporter within the central circulatory system, is critical in radiotherapy treatments. Ensuring compliance with the Central Drugs Standard Control Organization (CDSCO) regulations is paramount for legal marketing and patient safety.

CDSCO Regulatory Framework for Radiotherapy Devices

The CDSCO governs the import and manufacture of medical devices in India, categorizing devices into four risk classes (A to D) based on their potential risk to patients. Your device falls under Class D, indicating the highest risk category due to its direct therapeutic impact and the use of radioactive material. This classification mandates stringent regulatory scrutiny under the Medical Device Rules (MDR) 2017 and subsequent amendments.

Risk Classification and License Requirements for Class D Devices

Class D devices, such as the Central Circulatory Remote After Loading Brachytherapy System, require a central manufacturing license (MD9) granted by the CDSCO Central Licensing Authority. For importers, the Import License (MD15) is necessary. Both licenses involve extensive documentation, testing, and audits to verify compliance with safety and efficacy standards.

Manufacturing License Process (MD9) for Class D Devices

The MD9 license, applied through Form MD7, is issued by the CDSCO Central Licensing Authority. The process involves several critical steps:

1. Test License Acquisition (Form MD13): Before applying for MD9, obtain a test license which takes approximately 1.5 to 2 months.

2. Product Testing: Conduct mandatory testing of the device at government-approved laboratories. Testing ensures adherence to safety and performance criteria, including radiation safety standards. Refer to the list of testing laboratories authorized by CDSCO for validated testing.

3. Documentation Preparation: Compile comprehensive technical and quality documentation, including Device Master File, Plant Master File, Risk Management File, and Essential Principles Checklist.

4. License Application Submission: Submit the application via the CDSCO MD Online Portal using Form MD7.

5. CDSCO Audit: The CDSCO inspectors will perform an on-site audit to evaluate GMP compliance and technical capabilities.

6. Query Resolution: Address any queries or deficiencies raised by the CDSCO or auditors promptly.

7. Grant of License: Upon satisfactory evaluation, the MD9 license is granted.

Manufacturing License Documents Required

For your Class D radiotherapy device, the following documents are essential:

• Company Constitution (Incorporation Certificate, Partnership Deed, etc.)
• Proof of Ownership or Lease of Manufacturing Premises
• Qualification and Experience Certificates of Technical Staff
• Fire and Pollution No Objection Certificates (NOCs)
• Device Master File (DMF) detailing device design, specifications, and manufacturing process. Our Device Master File guide provides detailed insights.
• Plant Master File (PMF), describing the facility layout, equipment, and quality management system. Refer to our Plant Master File guide.
• Essential Principles Checklist confirming compliance with applicable standards
• Risk Management File, detailing hazard analysis and mitigation strategies. Implementing effective risk management is crucial for Class D devices.
• Test Reports from CDSCO-approved laboratories
• Product Labels, Instructions For Use (IFU), and Packaging Details
• Quality Management System (QMS) documents, preferably ISO 13485:2016 certification

Import License Process (MD15) for Class D Devices

For manufacturers outside India or importers intending to bring this device into India, the Import License (MD15) is mandatory. The process includes:

1. Document Preparation: Assemble all necessary documents, including the manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate (if applicable), Device and Plant Master Files, Wholesale License, and Company Constitution.

2. Application Submission: File the application on the CDSCO MD Online Portal using Form MD14.

3. Review and Query Resolution: The CDSCO Central Licensing Authority reviews the submission and may raise queries.

4. Grant of Import License: After satisfactory compliance, the MD15 license is issued.

Import License Documents Required

• Valid Manufacturing License from the country of origin
• Free Sale Certificate
• ISO 13485:2016 and CE Certificates
• Device Master File and Plant Master File
• Wholesale License for the importer
• Company Constitution and Address Proof

Timeline and Processing Duration

Manufacturers should anticipate a total of 5 to 7 months from initial test license application to manufacturing license grant. Importers typically experience 5 to 6 months for the import license.

Government Fees and Costs

• MD9 License: ₹50,000 per application plus ₹1,000 per product.
• Test License (MD13): Fees as prescribed by CDSCO, generally included in the overall process.
• MD15 Import License: Fees vary by device class; for Class D devices, approximately $3,000 per site and$1,500 per product.

Budgeting for these fees upfront is essential to avoid delays.

Common Challenges and Solutions

Challenge: Delays due to incomplete documentation or non-compliance with audit requirements.

Solution: Engage expert consultants to prepare and review documents thoroughly before submission. Utilize our detailed MD9 License Guide for step-by-step assistance.

Challenge: Difficulty in securing testing slots at government-approved labs.

Solution: Early coordination with testing labs listed on the CDSCO Testing Laboratories page can mitigate scheduling conflicts.

Challenge: Understanding and implementing regulatory requirements for radioactive devices.

Solution: Comprehensive risk management and adherence to radiation safety standards are non-negotiable. Our Risk Management guide offers practical strategies.

Expert Consultation and Support

With over 25 years of experience and over 500 successful CDSCO license approvals, we provide tailored support for high-risk device manufacturers and importers. Our services include:

• Gap analysis and regulatory strategy development
• Document preparation and review
• Coordination with notified bodies and CDSCO authorities
• Audit readiness and mock inspections
• Post-approval compliance assistance

Getting Started with Your CDSCO License Application

1. Classify Your Device: Confirm your device’s Class D status using resources like the Medical Device Classification guide.

2. Prepare Documentation: Start compiling your Device Master File, Plant Master File, Risk Management documentation, and QMS certifications.

3. Apply for Test License (MD13): Submit the application through the CDSCO MD Online Portal.

4. Schedule Testing: Coordinate with CDSCO-approved laboratories early.

5. Plan for Audit: Engage with a notified body or CDSCO inspectors for audits.

6. Submit Manufacturing License Application (MD9): Use Form MD7 upon successful testing and documentation readiness.

7. For Importers: Compile import-specific documents and apply for MD15 license.

By following this structured approach and leveraging expert guidance, manufacturers and importers can navigate the complex CDSCO licensing process efficiently, ensuring your Central Circulatory Remote After Loading Brachytherapy Therapeutic Radionuclide System reaches patients safely and compliantly.