CDSCO License for Radionuclide dose calibrator

Comprehensive Guide to CDSCO Licensing for Radionuclide Dose Calibrators (Class B Medical Device)

As a specialized radiation detection device, the Radionuclide Dose Calibrator plays a critical role in interventional radiology by accurately assaying radionuclides prior to patient administration. Given its essential function and associated risks, regulatory compliance with the Central Drugs Standard Control Organization (CDSCO) in India is mandatory before marketing or manufacturing this device.

With over 25 years of regulatory consultancy experience and having supported more than 500 companies in securing CDSCO licenses, we provide you with a detailed, practical roadmap to navigate the licensing process effectively.

CDSCO Regulatory Framework for Radionuclide Dose Calibrators

The regulatory oversight for medical devices in India falls under the Medical Device Rules, 2017, enforced by CDSCO. The radionuclide dose calibrator, classified under Class B (Low Moderate Risk) devices, requires adherence to specific registration, licensing, testing, and quality management norms.

This device is notified under the Gazette Notification 29/Misc./03/2020-DC (146) dated 26.07.2021, mandating compliance with CDSCO licensing protocols before manufacturing or import.

Risk Classification and License Requirements

According to CDSCO’s risk classification system:

• Class B Devices include low to moderate risk instruments such as radionuclide dose calibrators.
• These devices require a Manufacturing License (MD5 License) granted by the State Licensing Authority.

For detailed classification criteria, refer to our guide on Medical Device Classification.

Manufacturing License Process for Radionuclide Dose Calibrators (MD5 License)

The MD5 license process involves several key steps:

1. Test License (Form MD13): Obtain a test license to manufacture the device on a trial basis. This takes approximately 1.5 to 2 months.
2. Product Testing: Conduct mandatory product testing at CDSCO-approved government laboratories. You can find the list of approved labs here.
3. Document Preparation: Prepare comprehensive documentation including Device Master File, Plant Master File, Risk Management File, and Quality Management System (QMS) documents.
4. Application Submission: File the manufacturing license application on Form MD3 through the CDSCO MD Online Portal.
5. Notified Body Audit: Coordinate with a notified body for the mandatory audit. A list of notified bodies authorized for MD5 audit is available here.
6. Queries and Clarifications: Address any queries raised by CDSCO or the notified body promptly.
7. License Grant: Upon successful compliance, the license is granted on Form MD5.

Manufacturing License Documents Required for Radionuclide Dose Calibrators

The following documents are essential for the MD5 license application:

• Company Constitution Proof: Certificate of incorporation/registration.
• Proof of Ownership or Lease of Premises: Valid rental agreement or ownership documents.
• Technical Staff Details: Qualification and experience certificates of technical personnel.
• Fire and Pollution NOCs: Obtain from local authorities to ensure facility compliance.
• Device Master File (DMF): Detailed device specifications, manufacturing processes, and quality controls. Our Device Master File guide offers comprehensive insights.
• Plant Master File (PMF): Details of the manufacturing site, infrastructure, and equipment. Visit our Plant Master File guide for help.
• Essential Principles Checklist: Declaration of conformity to CDSCO’s standards.
• Risk Management File: Risk analysis and mitigation strategies aligned with international standards. Learn more about Risk Management.
• Test Reports: Certificate of testing from CDSCO-approved labs.
• Product Labels and Instructions for Use (IFU): Compliant with Indian regulatory requirements.
• Quality Management System Documents: ISO 13485 certification and internal QMS manuals.

Import License Process for Radionuclide Dose Calibrators (MD15 License)

If you are an importer, the process differs:

• No test license is required.
• You must prepare detailed documentation including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE certificate, and relevant master files.
• Submit application on Form MD14 via the CDSCO MD Online Portal.
• Address queries raised by CDSCO.
• License granted on Form MD15 by the Central Licensing Authority.

For more on import licensing, see our Import License Guide.

Import License Documents Required

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

Timeline and Processing Duration

Government Fees and Costs

• Application Fee: ₹5,000 per application
• Product Fee: ₹500 per product

Note: Additional costs may include fees for notified body audits, product testing charges, and consultancy services.

Common Challenges and Practical Solutions

• Delayed Product Testing: Scheduling tests at government labs can be time-consuming. Plan well in advance and consider labs with shorter turnaround times.
• Incomplete Documentation: Missing or improperly formatted documents cause delays. Utilize checklists and expert reviewers to ensure completeness.
• Audit Non-Compliance: Non-conformities during notified body audits can stall licensing. Conduct internal mock audits to prepare.
• Regulation Updates: Stay updated with CDSCO notifications and amendments affecting your device category.

Expert Consultation and Support

Navigating CDSCO licensing can be complex without experienced guidance. Our team has successfully facilitated over 500 license approvals for devices like radionuclide dose calibrators. We offer:

• End-to-end application handling
• Document drafting and review
• Coordination with notified bodies and test labs
• Regulatory updates and compliance strategy

Engaging expert support significantly reduces processing time and improves approval success rates.

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm your device falls under Class B.
2. Prepare Test License Application (MD13): Gather preliminary documents and apply via the CDSCO MD Online Portal.
3. Schedule Product Testing: Identify appropriate government laboratories early.
4. Compile Required Documentation: Use our detailed guides on Device and Plant Master Files.
5. Engage a Notified Body: Select from the list of notified bodies approved for MD5 audits.
6. Submit Manufacturing License Application (MD3): After successful testing and document readiness.
7. Prepare for Audit and Queries: Have a dedicated team to respond swiftly.

Starting early and adopting a methodical approach ensures a smoother approval journey for your radionuclide dose calibrator in India.

For personalized assistance or detailed process walkthroughs, feel free to reach out to our regulatory experts who specialize in CDSCO licensing for interventional radiology devices.

By following this comprehensive guide, manufacturers and importers can confidently navigate the CDSCO licensing process, ensuring timely market access for their radionuclide dose calibrators while maintaining compliance with Indian regulatory standards.