CDSCO License for Brachytherapy needle

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

As a medical device manufacturer or importer aiming to enter the Indian market with a Brachytherapy needle, understanding the regulatory landscape set by the Central Drugs Standard Control Organization (CDSCO) is crucial. With over 25 years of experience and having assisted 500+ companies, we provide a detailed roadmap to secure your MD5 manufacturing license—tailored specifically for this Class B radiotherapy device.

Understanding the Brachytherapy Needle and Its Regulatory Importance

The brachytherapy needle is a sterile, bevel-edged, hollow tubular metal instrument designed to inject radionuclides for cancer therapy directly into body cavities or tissues. Given its critical role in radiotherapy, the device falls under Class B (low moderate risk), necessitating strict compliance with CDSCO regulations for safety and efficacy.

CDSCO Regulatory Framework for Brachytherapy Needles

The regulatory framework for medical devices like the brachytherapy needle is governed by the Medical Device Rules (MDR), 2017, under the Drugs and Cosmetics Act, 1940. Class B devices require licensing through the State Licensing Authority via the MD5 license (Form MD3 application form). The process ensures the device meets Indian standards and international best practices for patient safety.

For comprehensive classification details, manufacturers can refer to the Medical Device Classification guide.

Risk Classification and License Requirements for Class B Devices

• Risk Class: B
• License Type: MD5 Manufacturing License
• Regulatory Authority: State Licensing Authority
• Test License: MD13 (mandatory before MD5 application)
• Audit: Conducted by a notified body from the official CDSCO list of notified bodies

Manufacturing License Process for Brachytherapy Needle (MD5)

1. Obtain Test License (Form MD13): Apply for this license on the CDSCO MD Online Portal – it typically takes 1.5 to 2 months.
2. Product Testing: Submit samples to government-approved testing laboratories listed on the CDSCO Testing Laboratories page. Testing duration depends on lab workload but usually completes within 4-6 weeks.
3. Documentation Preparation: Compile essential documents including Device Master File, Plant Master File, Risk Management File, and Quality Management System (QMS) documents.
4. Application Submission: File the MD5 license application (Form MD3) via the MD Online portal.
5. Audit by Notified Body: A notified body will audit your manufacturing facility and documentation.
6. Resolve Queries: Address any observations raised by the department or notified body.
7. License Grant: Upon successful compliance, the State Licensing Authority issues the MD5 license (Form MD5).

Manufacturing License Documents Required

For the brachytherapy needle, ensure you have the following documents ready:

• Company Constitution and Incorporation Certificates
• Proof of Ownership or Lease of Manufacturing Premises
• Details and Qualifications of Technical Staff
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF): Detailed specifications and manufacturing process (Device Master File Guide)
• Plant Master File (PMF): Description of manufacturing site and equipment (Plant Master File Guide)
• Essential Principles Checklist
• Risk Management File (Risk Management Guide)
• Test Reports from government-approved labs
• Labeling and Instructions for Use (IFU)
• Quality Management System Documents (ISO 13485 certification is highly recommended)

Import License Process for Brachytherapy Needle (MD15)

If you plan to import brachytherapy needles, the MD15 import license is mandatory. This license is granted by the Central Licensing Authority and requires:

• Manufacturing license from the country of origin
• Free Sale Certificate
• ISO 13485:2016 certification
• CE Certificate or equivalent
• Device and Plant Master Files
• Wholesale license
• Company Constitution

The MD15 license application (Form MD14) is submitted on the CDSCO MD Online Portal. The process typically takes 5-6 months, with government fees based on risk class.

Timeline and Processing Duration

Government Fees and Costs

• Test License (MD13): Rs 5,000 (approximate, varies by state)
• MD5 License Application Fee: Rs 5,000 per application
• Product Fee: Rs 500 per product (per variation or SKU)

Additional costs may include fees for notified body audits, testing lab charges, and consultant fees if you opt for expert guidance.

Common Challenges and Solutions

Challenge: Delay in product testing due to lab backlogs.

Solution: Engage early with CDSCO-approved testing labs and submit samples promptly after securing the test license.

Challenge: Incomplete or inconsistent documentation.

Solution: Leverage comprehensive templates and checklists for Device Master File and Plant Master File preparation. Our Device Master File Guide and Plant Master File Guide can be invaluable resources.

Challenge: Audit non-compliance issues.

Solution: Pre-audit self-assessment and consultation with notified bodies listed on CDSCO's Notified Bodies List can help identify and rectify gaps beforehand.

Expert Consultation and Support

Navigating the CDSCO licensing process can be complex, especially for specialized devices like brachytherapy needles. Our expert team offers tailored support—from documentation to audit readiness—to streamline your licensing journey. With over two decades of regulatory consulting and 500+ successful license approvals, we understand the nuances and can help you avoid costly delays.

Getting Started with Your CDSCO License Application

1. Register on the CDSCO MD Online Portal: Visit the official portal to create your account and familiarize yourself with the submission process.
2. Initiate Test License Application: Begin with the MD13 test license to enable product testing.
3. Engage Accredited Testing Laboratories: Schedule your product testing promptly upon receipt of the test license.
4. Prepare Documentation: Use our guides and templates to assemble your Device Master File, Plant Master File, Risk Management File, and other mandatory documents.
5. Schedule Notified Body Audit: Coordinate with notified bodies early to plan your facility audit.
6. Submit MD5 Application: Upload your complete application after successful testing and audit.
7. Follow Up and Respond: Address queries from CDSCO or the notified body in a timely manner.

Taking these proactive steps will position your brachytherapy needle for swift regulatory approval, enabling market access to this vital radiotherapy device.

For detailed guidance tailored to your specific circumstances, please contact our regulatory consultancy. Together, we can navigate the complexities of CDSCO licensing and ensure your brachytherapy needles meet all Indian regulatory requirements efficiently.