CDSCO License for Biliary/urinary stone retrieval basket

Comprehensive Guide to CDSCO Licensing for Biliary/Urinary Stone Retrieval Basket (Class B Medical Device)

As a trusted regulatory consultant with over 25 years of experience and having assisted more than 500 medical device companies, we understand the complexities involved in securing CDSCO licenses in India. This guide provides manufacturers and importers with all the essential details to obtain a CDSCO manufacturing or import license specifically for the biliary/urinary stone retrieval basket — a Class B urology device designed for endoscopic removal of biliary or urinary stones.

Understanding the Biliary/Urinary Stone Retrieval Basket and Its Regulatory Importance

The biliary/urinary stone retrieval basket is a flexible, manual instrument widely used in endoscopic procedures to extract gallbladder or renal calculi safely. Given its invasive use and direct contact with body tissues, the device falls under Risk Class B as per CDSCO’s classification, signifying a moderate risk to patients and users. Consequently, it requires stringent regulatory oversight to ensure safety, efficacy, and quality before it can be marketed or manufactured in India.

The CDSCO notification for this device, File No. 29/Misc./03/2020-DC (145), dated 23.08.2021, confirms its regulated status under the medical device rules, emphasizing the need for proper licensing.

CDSCO Regulatory Framework for Class B Urology Devices

India’s regulatory framework for medical devices is overseen by the Central Drugs Standard Control Organization (CDSCO). Medical devices are categorized into four classes (A, B, C, D) based on risk, with Class B devices like the biliary/urinary stone retrieval basket requiring a Manufacturing License (MD5) issued by the State Licensing Authority.

The regulatory pathway involves:

• Obtaining a Test License (Form MD13) for initial product testing
• Conducting mandatory product testing at government-approved laboratories
• Preparing comprehensive documentation including Device Master File (DMF), Plant Master File (PMF), and Risk Management File
• Application submission on the CDSCO MD Online Portal
• On-site audit by a notified body
• Resolution of any queries
• Final grant of the MD5 Manufacturing License (Form MD3)

Risk Classification and License Requirements for Biliary/Urinary Stone Retrieval Basket

Since the device is classified as Class B, the applicable license is the MD5 Manufacturing License. This license is issued by the State Licensing Authority and involves a detailed process that generally takes about 3 to 4 months end to end.

Key points:

• License Form: MD3 for application, MD5 for license grant
• Test License on Form MD13 mandatory before full license
• Audit by a notified body from this list
• Product testing at CDSCO approved labs

Manufacturing License Process (MD5) for Class B Devices

1. Apply for Test License (Form MD13): The first step involves applying for a test license on the CDSCO portal, allowing you to manufacture a limited quantity for testing. This process typically takes 1.5 to 2 months.

2. Product Testing: The biliary/urinary stone retrieval basket must be tested per Indian standards at government-approved laboratories to verify compliance with essential principles.

3. Document Preparation: Prepare all required documents, including the Device Master File, Plant Master File, Risk Management File, Quality Management System (QMS) documentation, and other supporting documents.

4. Application for MD5 License (Form MD3): Submit the full license application online via the CDSCO MD Online Portal.

5. Notified Body Audit: A notified body conducts an on-site audit of the manufacturing facility to verify compliance with regulatory requirements.

6. Query Resolution: Address any observations or queries raised by CDSCO or the notified body promptly.

7. License Grant: Upon satisfactory compliance, CDSCO grants the MD5 manufacturing license.

For more detailed insights, refer to our specialized MD5 License Guide.

Manufacturing License Documents Required for Biliary/Urinary Stone Retrieval Basket

To ensure a smooth licensing process, prepare the following documents meticulously:

• Constitution of the company (Certificate of Incorporation, Memorandum & Articles of Association)
• Proof of ownership or lease of manufacturing premises
• Details and qualifications of technical staff
• Fire No-Objection Certificate (NOC)
• Pollution Control Board Clearance (if applicable)
• Device Master File (DMF) detailing device design, manufacturing processes, and specifications (Learn more about DMF)
• Plant Master File (PMF) describing the manufacturing facility and quality systems (PMF guide here)
• Essential Principles Checklist
• Risk Management File demonstrating compliance with risk mitigation norms (Risk Management details)
• Test Reports from CDSCO-approved laboratories
• Labels and Instructions for Use (IFU) compliant with Indian regulations
• Quality Management System (QMS) documents such as ISO 13485 certification

Import License Process (MD15) for Biliary/Urinary Stone Retrieval Basket

If you are an importer rather than a manufacturer, the process differs. For Class B devices, an MD15 Import License is required from the Central Licensing Authority.

Steps include:

• Document preparation including Manufacturing License from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device Master File, Plant Master File, Wholesale license, and company constitution
• Submission of application on the CDSCO MD Online Portal
• Departmental review and query resolution
• Grant of MD15 license

The import license process generally takes 5-6 months. For detailed guidance, review our Import License Guide.

Import License Documents Required

• Valid manufacturing license of the device from the country of origin
• Free Sale Certificate from exporting country
• ISO 13485:2016 certification
• CE Certificate or equivalent conformity assessment
• Device Master File (DMF) and Plant Master File (PMF)
• Wholesale Drug License (if applicable)
• Company Constitution and PAN

Timeline and Processing Duration for Class B Device Licensing

Total Estimated Time: Approximately 3 to 4 months.

Government Fees and Costs for MD5 License (Class B Device)

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

Additional costs may include:

• Fees for product testing at government labs
• Notified body audit charges (varies by body)
• Consultancy and documentation preparation costs

Common Challenges and Solutions in CDSCO Licensing for Stone Retrieval Baskets

Challenge 1: Delays in product testing due to limited slots at approved laboratories.

Solution: Schedule testing early after test license approval and consider alternate approved labs from the CDSCO list.

Challenge 2: Incomplete or inconsistent documentation causing audit non-conformities.

Solution: Utilize comprehensive templates for DMF, PMF, and risk files and conduct internal audits before submission.

Challenge 3: Queries and delays during audit response.

Solution: Engage experienced consultants to prepare prompt, thorough responses addressing all observations.

Expert Consultation and Support

Navigating the CDSCO licensing process for Class B devices like the biliary/urinary stone retrieval basket can be complex. Our team offers:

• End-to-end regulatory strategy and submission support
• Documentation preparation including Device and Plant Master Files
• Coordination with notified bodies and laboratories
• Audit readiness and training
• Post-approval compliance management

Our hands-on approach has helped over 500 companies successfully obtain their licenses efficiently and compliantly.

Getting Started with Your CDSCO License Application

1. Assess your product classification and intended use carefully to confirm Class B status.
2. Register on the CDSCO MD Online Portal and familiarize yourself with the submission process.
3. Initiate the Test License application (Form MD13) immediately to avoid delays.
4. Begin compiling your documentation using our detailed guides for DMF, PMF, and risk management.
5. Identify and engage a notified body early for audit scheduling from the official notified bodies list.
6. Plan your product testing with approved labs to fit within your project timeline.
7. Consider expert consultancy to streamline the process and avoid common pitfalls.

By taking these practical steps, you can confidently progress toward obtaining your CDSCO MD5 manufacturing license for your biliary/urinary stone retrieval basket and enter the Indian market with compliance and assurance.

For personalized assistance, reach out to our regulatory experts who have decades of proven success in CDSCO licensing for medical devices.

Note: All timelines and fees are indicative and subject to change as per CDSCO updates. Always verify on the official portal.