CDSCO License for Brachytherapy radionuclide phantom, anthropomorphic

Comprehensive Guide to CDSCO Licensing for Brachytherapy Radionuclide Phantom (Class B Medical Device)

At our firm, with over 25 years of experience and having successfully guided 500+ companies, we understand the critical importance of obtaining timely and compliant CDSCO licenses for medical devices like the Brachytherapy radionuclide phantom, anthropomorphic. This specialized radiotherapy device, classified as Class B under Indian regulations, requires a detailed and strategic approach to navigate the regulatory framework set by the Central Drugs Standard Control Organization (CDSCO).

Understanding the Brachytherapy Radionuclide Phantom and Its Regulatory Importance

The Brachytherapy radionuclide phantom is a two or three-dimensional anthropomorphic device designed to simulate human organ characteristics for radiotherapy applications. Since it involves human tissue-equivalent models, ensuring safety, efficacy, and quality through regulatory oversight is paramount. CDSCO classification as a Class B device implies moderate risk, necessitating stringent compliance yet manageable licensing requirements.

CDSCO Regulatory Framework for Brachytherapy Radionuclide Phantom

Under the Medical Device Rules (MDR) 2017, the Brachytherapy radionuclide phantom falls under Class B, requiring a manufacturing license from the State Licensing Authority via Form MD3 (MD5 license). For importers, the process involves applying for an import license (MD15) from the Central Licensing Authority.

The regulatory process includes obtaining a test license (MD13), product testing from government-approved laboratories, document submission, and an audit by a notified body.

Risk Classification and License Requirements for Class B Devices

Class B devices like the Brachytherapy radionuclide phantom are considered low to moderate risk. They demand:

• Manufacturing License: MD5 (Form MD3) issued by the State Licensing Authority.
• Test License: MD13 for initial product testing.
• Audit: By a notified body listed on the CDSCO portal.

For detailed classification insights, consult our Medical Device Classification guide.

Manufacturing License Process (MD5) for Brachytherapy Radionuclide Phantom

1. Obtain Test License (MD13): Apply for a test license to manufacture samples for testing. This takes approximately 1.5 to 2 months.
2. Product Testing: Submit samples to CDSCO-approved testing laboratories. Visit the Testing Laboratories list to identify suitable labs.
3. Document Preparation: Compile comprehensive documents including Device Master File (DMF), Plant Master File (PMF), Risk Management File, and Quality Management System (QMS) documentation.
4. Application Submission: File Form MD3 through the CDSCO MD Online Portal.
5. Audit by Notified Body: Coordinate with a notified body from the Notified Bodies List for a facility audit.
6. Query Resolution: Address any queries raised by CDSCO or the notified body promptly.
7. License Grant: Upon successful compliance, CDSCO issues the MD5 license.

Manufacturing License Documents Required

• Company Constitution and incorporation certificates
• Proof of ownership or lease of manufacturing premises
• Technical staff qualifications and experience details
• Fire No Objection Certificate (NOC)
• Pollution Control Board NOC
• Device Master File (DMF) – see our detailed Device Master File guide
• Plant Master File (PMF) – refer to our Plant Master File guide
• Essential Principles Checklist
• Risk Management File – aligned with ISO 14971 standards (Risk Management guide)
• Test Reports from government-approved labs
• Product labels and Instructions for Use (IFU)
• Quality Management System (QMS) documents, preferably ISO 13485 certified

Import License Process (MD15) for Brachytherapy Radionuclide Phantom

For manufacturers or distributors importing this device into India, an import license under Form MD14 is required, leading to issuance of the MD15 license by the Central Licensing Authority. The process includes:

• Preparing comprehensive import documentation
• Submitting the application via the CDSCO MD Online Portal
• Addressing CDSCO queries
• Awaiting license grant

No test license is required here, but you must ensure compliance with Indian standards and provide necessary certificates.

Import License Documents Required

• Valid Manufacturing License from the country of origin
• Free Sale Certificate issued by the regulatory authority of the exporting country
• ISO 13485:2016 certification
• CE Certificate or equivalent
• Device Master File and Plant Master File
• Wholesale license, if applicable
• Company Constitution

Timeline and Processing Duration

• MD5 Manufacturing License (Class B): Approximately 3-4 months total

  • Test License (MD13): 1.5-2 months
  • Product Testing: 2-4 weeks (depends on lab workload)
  • Audit and Queries: 1-1.5 months

• MD15 Import License: Typically takes 5-6 months

Government Fees and Costs

• MD5 License: Rs 5,000 per application + Rs 500 per product
• MD15 Import License: For Class B devices, fee is around $2,000 per site +$1,000 per product

Budgeting for ancillary costs such as testing fees, notified body audits, and document preparation is essential. Testing labs charge varying fees depending on the scope of tests.

Common Challenges and Solutions

Challenge: Delays in test license approval and product testing

Solution: Early submission of complete and accurate documentation for test license; engage with testing labs promptly.

Challenge: Insufficient documentation completeness, especially DMF and PMF

Solution: Use expert guidance and templates to prepare DMF and PMF, ensuring all regulatory expectations are met.

Challenge: Audit non-compliance findings

Solution: Conduct internal pre-audits and staff training before the official CDSCO notified body audit.

Challenge: Query resolution delays

Solution: Assign a dedicated regulatory liaison to respond swiftly and comprehensively to CDSCO queries.

Expert Consultation and Support

With decades of expertise, our consultancy offers tailored support for your Brachytherapy radionuclide phantom licensing journey. From document preparation to audit readiness and post-approval compliance, we provide end-to-end assistance ensuring smooth regulatory navigation.

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm Class B status and understand specific requirements.
2. Prepare Test Samples: Initiate test license application (Form MD13) through the CDSCO MD Online Portal.
3. Compile Critical Documents: Focus on DMF, PMF, Risk Management File, and QMS documentation.
4. Engage Testing Labs Early: Schedule testing with government-approved laboratories.
5. Coordinate with Notified Bodies: Pre-select notified bodies from the official list for timely audits.
6. Submit MD5 Application: File Form MD3 post successful testing.
7. Prepare for Audit and Queries: Conduct internal reviews and be ready to respond to regulatory clarifications.

Embarking on this structured pathway secures your compliance and market access for your Brachytherapy radionuclide phantom in India. For personalized support, reach out to our expert team to expedite your CDSCO licensing process with confidence.

Leverage our industry-leading expertise to transform your regulatory challenges into streamlined approvals and successful market entry.