CDSCO License for Breast ductography cannula

Comprehensive Guide to CDSCO Licensing for Breast Ductography Cannula (Class C Medical Device)

As a trusted regulatory consultancy with over 25 years of experience and having assisted more than 500 companies, we understand the nuances of securing CDSCO licenses in India for medical devices like the Breast Ductography Cannula. This device—a thin, sterile metal tube used in radiotherapy to inject contrast medium into breast lactiferous ducts—is classified as a Class C medical device under CDSCO regulations, which carries specific regulatory obligations.

Understanding the CDSCO Regulatory Framework for Breast Ductography Cannula

The Central Drugs Standard Control Organization (CDSCO) regulates all medical devices in India, classifying them into Classes A, B, C, and D based on risk. Your Breast Ductography Cannula falls under Class C due to its invasive nature and intended diagnostic use.

Being a Class C device categorized under Radiotherapy, the regulatory pathway involves obtaining the MD9 manufacturing license from the Central Licensing Authority and the MD15 import license if you intend to import the device into India.

Risk Classification and License Requirements for Class C Devices

• Risk Class: C
• License for Manufacturing: MD9 (Application Form MD7)
• License for Import: MD15 (Application Form MD14)
• Authority: Central Licensing Authority

This classification means the licensing process is more stringent than for Class A/B devices, involving comprehensive testing, audits, and documentation.

The Manufacturing License Process (MD9) for Breast Ductography Cannula

The MD9 manufacturing license application process typically spans about 4 to 5 months. Here is a breakdown:

1. Test License (MD13): Initiate with obtaining a test license on Form MD13, valid for 1.5 to 2 months, permitting you to conduct product tests.
2. Product Testing: Get your Breast Ductography Cannula tested at government-approved laboratories to verify compliance with applicable Indian standards.
3. Document Preparation: Compile all necessary documents, including technical and quality management files.
4. Application Submission: Apply for the MD9 license via Form MD7 on the CDSCO MD Online Portal.
5. Audit: CDSCO inspectors will conduct an audit of your manufacturing facility and quality management systems.
6. Query Resolution: Address any queries or deficiencies raised by the CDSCO during the review.
7. License Grant: Upon successful audit and review, the MD9 license is granted.

Manufacturing License Documents Required for MD9

For your Breast Ductography Cannula, the documentation needs to be precise and thorough. Essential documents include:

• Company Constitution and Incorporation Certificate
• Proof of ownership or lease agreement of the manufacturing premises
• Qualification and experience records of technical staff
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF): Detailed design and manufacturing process information. For guidance, see our Device Master File guide.
• Plant Master File (PMF): Details of the manufacturing facility; refer to our Plant Master File guide.
• Essential Principles Checklist demonstrating conformity to Indian regulations
• Risk Management File documenting identified risks and mitigation steps
• Product Test Reports from government-approved laboratories (check Testing Laboratories)
• Labeling and Instructions for Use (IFU) compliant with CDSCO requirements
• Quality Management System (QMS) documents, preferably ISO 13485:2016 certification

Import License Process (MD15) for Breast Ductography Cannula

For importing this Class C device, the MD15 license application process generally takes 5 to 6 months and does not require a test license.

Process overview:

1. Preparation of Documents: Ensure you have all import-specific documents.
2. Application Submission: Submit Form MD14 on the CDSCO MD Online Portal.
3. Review and Queries: Respond promptly to any CDSCO queries.
4. License Issuance: Once approved, the MD15 import license is granted.

Import License Documents Required for MD15

• Valid Manufacturing License (MD9) from the country of origin
• Free Sale Certificate issued by the regulatory authority of the exporting country
• ISO 13485:2016 Certificate
• CE Certificate or equivalent international certification
• Device Master File and Plant Master File
• Wholesale License for distribution in India
• Company Constitution and incorporation documents

Timeline and Processing Duration

Government Fees and Costs

Note: Fees are payable online via the CDSCO MD Online Portal during application submission.

Common Challenges and Practical Solutions

• Delayed Test Reports: Government labs can have backlogs. Mitigate this by scheduling tests in advance and considering notified private labs if approved.
• Incomplete Documentation: Use detailed checklists and our Device Master File guide to avoid omissions.
• Audit Non-Compliance: Prepare your QMS and staff thoroughly; pre-audit mock checks can help.
• Query Resolutions: Respond promptly and clearly to CDSCO queries to avoid prolonged delays.

Expert Consultation and Support

Navigating CDSCO licensing for a Class C device like the Breast Ductography Cannula can be complex. Our team provides end-to-end support—from documentation preparation and testing coordination to audit readiness and application submission.

With over 500 successful licensing projects, we help streamline your journey, reduce turnaround times, and ensure compliance with all regulatory requirements.

Getting Started with Your CDSCO License Application

1. Assess Device Classification: Confirm your device is Class C as per CDSCO guidelines (Medical Device Classification).
2. Prepare Documentation: Start compiling your Device Master File and Plant Master File.
3. Apply for Test License: For manufacturing, submit Form MD13 for a test license via the CDSCO MD Online Portal.
4. Schedule Product Testing: Coordinate with notified government testing labs (Testing Laboratories).
5. Submit License Application: Once testing is complete, apply for MD9 manufacturing license (Form MD7) or MD15 import license (Form MD14) as applicable.
6. Plan for Audit: Engage with notified bodies or CDSCO inspectors for audits. A list of Notified Bodies is available for reference.
7. Engage Expert Help: Leverage our consultancy to navigate the process efficiently and avoid common pitfalls.

Embarking on your CDSCO licensing journey for the Breast Ductography Cannula requires careful planning and adherence to stringent regulatory norms. By following this expert guide and leveraging our extensive experience, you can confidently position your device in the Indian market.

For personalized assistance and detailed project support, connect with our regulatory experts today.