CDSCO License for Biopsy Needle Kit

Comprehensive Guide to CDSCO Licensing for Biopsy Needle Kit (Class B)

As specialists with over 25 years of experience and having successfully assisted more than 500 companies in obtaining CDSCO medical device licenses, we understand the critical nuances involved in bringing a device like the Biopsy Needle Kit to the Indian market. This neurosurgical device, classified under Class B (Disposable Hypodermic Needles), requires strict adherence to the CDSCO regulatory framework to ensure compliance and timely approval.

Understanding the Biopsy Needle Kit and Regulatory Importance

The Biopsy Needle Kit is a specialized neurosurgical instrument designed to obtain multiple biopsies from one or more targets within a single trajectory. Given its invasive nature and direct patient contact, regulatory oversight by the CDSCO ensures the device meets safety, efficacy, and quality standards before it reaches healthcare providers. The notification 29/Misc/3/2017-DC (292), dated 06.06.2018, officially categorizes this device under Disposable Hypodermic Needles, Class B.

CDSCO Regulatory Framework for Class B Medical Devices

Under the Medical Device Rules (MDR) 2017, devices are divided into Class A, B, C, and D, based on risk. Class B devices like the Biopsy Needle Kit are considered low to moderate risk, requiring a manufacturing license (MD5) from the State Licensing Authority. Importers must obtain an import license (MD15) from the Central Authority.

Risk Classification and License Requirements for Biopsy Needle Kit

• Classification: Class B
• Category: Disposable Hypodermic Needles
• Applicable License for Manufacturing: MD5 (Form MD3)
• Applicable License for Import: MD15 (Form MD14)
• Regulatory Authority: State Licensing Authority for manufacturing; Central Licensing Authority for import

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

Manufacturing License Process (MD5) for Biopsy Needle Kit

1. Test License (Form MD13): Initiate with a test license application, which takes approximately 1.5 to 2 months. This allows product testing in government-approved laboratories.
2. Product Testing: Submit the Biopsy Needle Kit samples to CDSCO-approved labs such as those listed on the Testing Laboratories page for safety and performance validation.
3. Document Preparation: Compile all technical and quality documents including Device Master File, Plant Master File, risk management files, and labels.
4. Apply for MD5 License (Form MD3): Submit your application through the CDSCO MD Online Portal.
5. Audit by Notified Body: A mandatory audit will be conducted by a notified body; check the list of notified bodies to select the appropriate auditor.
6. Query Resolution: Address any queries raised by the licensing authority or notified body promptly.
7. Grant of MD5 License: Upon satisfactory compliance, the license is granted in Form MD5.

Total process duration is typically 3 to 4 months, including testing, audit, and documentation.

Manufacturing License Documents Required

• Company Constitution (e.g., Memorandum and Articles of Association)
• Proof of ownership or valid lease agreement of the manufacturing premises
• Qualification and experience certificates of technical staff
• Fire No Objection Certificate (NOC)
• Pollution Control Board NOC
• Device Master File (DMF) – detailed design and manufacturing process documents (Device Master File guide)
• Plant Master File (PMF) – facility details and quality system information (Plant Master File guide)
• Essential Principles Checklist demonstrating compliance with safety and performance requirements
• Risk Management File following ISO 14971 principles (Risk Management guide)
• Test Reports from approved laboratories
• Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documentation (preferably ISO 13485:2016 certified)

Import License Process (MD15) for Biopsy Needle Kit

For importers, the MD15 license is granted by the Central Licensing Authority. The steps include:

1. Document Preparation: Prepare necessary documents including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485 certification, CE Certificate, Device and Plant Master Files, and wholesale license.
2. Application Submission: Apply through the CDSCO MD Online Portal.
3. Query Resolution: Respond promptly to any queries raised by CDSCO.
4. Grant of MD15 License: After satisfying compliance, the import license is issued in Form MD15.

The entire process generally takes 5 to 6 months.

Import License Documents Required

• Manufacturing License issued by the country of origin
• Free Sale Certificate
• ISO 13485:2016 Certificate
• CE Certificate (if applicable)
• Device Master File
• Plant Master File
• Wholesale License
• Company Constitution documents

Timeline and Processing Duration

Planning ahead is critical; starting the test license and document preparation early can optimize timelines.

Government Fees and Costs

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

Additional costs include laboratory testing fees and notified body audit charges, which vary by service provider.

Common Challenges and Solutions

• Delayed Document Preparation: To avoid setbacks, maintain a checklist and assign dedicated resources for compiling the DMF, PMF, and risk files.
• Test Report Rejections: Ensure samples are representative and testing labs are CDSCO-approved to avoid retesting delays.
• Audit Non-Conformities: Engage with experienced notified bodies early and conduct internal audits to prepare thoroughly.
• Query Resolution Delays: Respond promptly with clear, well-documented replies to departmental queries.

Expert Consultation and Support

Navigating the CDSCO licensing landscape can be complex. Our consultancy offers tailored support, from documentation assistance to audit readiness and query management, ensuring your Biopsy Needle Kit complies seamlessly with CDSCO requirements.

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm your device is Class B as per CDSCO guidelines.
2. Prepare Required Documentation: Begin compiling your Device and Plant Master Files, test reports, and quality documents.
3. Apply for Test License (MD13): Submit your application early to initiate product testing.
4. Engage a Notified Body: Schedule your audit in parallel to streamline timelines.
5. Use the CDSCO MD Online Portal: Submit all applications via the official portal.
6. Plan for Compliance: Implement a robust risk management system and maintain open communication with regulatory authorities.

By following this structured approach and leveraging our extensive expertise, manufacturers and importers can confidently navigate the CDSCO licensing process for the Biopsy Needle Kit and successfully enter the Indian medical device market.