CDSCO License for Biliary Stone Retrieval Basket

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

With over 25 years of experience assisting 500+ medical device manufacturers and importers, we understand the critical nuances of obtaining CDSCO licenses in India. This guide focuses on the Biliary Stone Retrieval Basket, a Class B catheter device designed for antegrade extraction of stones through an ampullary orifice treated by endoscopic sphincterotomy or balloon dilation. Navigating the regulatory landscape efficiently ensures faster market access and compliance with Indian regulations.

Understanding the CDSCO Regulatory Framework for Biliary Stone Retrieval Basket

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India under the Medical Device Rules, 2017. Your device falls under Class B, indicating a low to moderate risk profile. The regulatory framework mandates obtaining a manufacturing license (MD5) or import license (MD15) before placing the device in the Indian market.

Risk Classification and License Requirements for Class B Devices

The Biliary Stone Retrieval Basket is classified as a Class B device by CDSCO, confirmed under notification 29/Misc/3/2017-DC (292) dated 06.06.2018. As a Class B device, manufacturers must apply for an MD5 license (manufacturing) through the State Licensing Authority, whereas importers require an MD15 import license granted by the Central Licensing Authority.

MD5 Manufacturing License Process for Biliary Stone Retrieval Basket

The MD5 license application is a multi-step process typically completed within 3-4 months. The process includes:

1. Test License (Form MD13): Initially, obtain a test license which takes approximately 1.5-2 months.
2. Product Testing: Conduct testing at CDSCO-approved laboratories to validate safety and performance as per Indian standards.
3. Document Preparation: Compile all regulatory documents including Device Master File and Plant Master File.
4. Application Submission (Form MD3): Submit your MD5 license application via the CDSCO MD Online Portal.
5. Audit: Undergo an audit by a notified body listed in the official directory.
6. Query Resolution: Address any clarifications raised by the authorities or auditors promptly.
7. License Grant (Form MD5): Upon successful review, the license is granted.

Manufacturing License Documents Required

For the Biliary Stone Retrieval Basket, prepare the following detailed documentation:

• Company Constitution and Incorporation Proof
• Premises Ownership or Lease Documents
• Technical Staff Qualification Proofs
• Fire and Pollution NOCs
• Device Master File (DMF): Detailed design, specifications, and manufacturing process (Device Master File Guide)
• Plant Master File (PMF): Facility details and quality systems (Plant Master File Guide)
• Essential Principles Checklist: Compliance checklist for safety and performance
• Risk Management File: Hazard analysis and mitigation strategies
• Test Reports: Results from CDSCO-approved laboratories (Testing Laboratories)
• Labeling and Instructions for Use (IFU)
• Quality Management System (QMS) Documentation: ISO 13485 compliance records

Import License Process (MD15) for Biliary Stone Retrieval Basket

If you intend to import the device into India, an MD15 license is mandatory. This process takes approximately 5-6 months and involves:

1. Document Compilation: Prepare manufacturing license, Free Sale Certificate, ISO 13485:2016 certificate, CE certification, DMF, PMF, wholesale license, and company constitution.
2. Application Submission: File Form MD14 on the CDSCO MD Online Portal.
3. Queries Resolution: Respond promptly to CDSCO requests.
4. License Issuance: Upon compliance, the MD15 import license is granted.

Import License Documents Required

• Valid Manufacturing License from the country of origin
• Free Sale Certificate issued by the regulatory authority abroad
• ISO 13485:2016 certification
• CE Certificate (if applicable)
• Device Master File and Plant Master File
• Wholesale License in India
• Company Constitution documents

Timeline and Processing Duration Summary

Government Fees and Costs for Biliary Stone Retrieval Basket

For Class B devices, the fees are as follows:

• MD5 Manufacturing License: Rs. 5,000 per application + Rs. 500 per product
• MD15 Import License: $2,000 per site +$1,000 per product

Bear in mind these fees exclude costs related to product testing, audit fees by notified bodies, and consultancy if engaged.

Common Challenges and Practical Solutions

• Delayed Test Reports: Engage early with CDSCO-approved labs—book your testing slots in advance.
• Incomplete Documentation: Use detailed checklists; our Device Master File guide aids comprehensive documentation.
• Audit Non-compliance: Conduct internal audits before official inspections; hire experienced consultants.
• Query Management: Respond to CDSCO queries within stipulated timelines to avoid delays.

Expert Consultation and Support

Our extensive experience with over 500 successful CDSCO license projects means we understand the critical pain points and regulatory nuances specific to Class B devices like the Biliary Stone Retrieval Basket. We offer tailored support including document review, audit readiness, and liaison with CDSCO authorities to smooth your licensing journey.

Getting Started with Your CDSCO License Application

1. Assess Device Classification: Confirm Class B status per Medical Device Classification.
2. Initiate Test License: Apply for Form MD13 to start product testing.
3. Compile Documentation: Assemble your DMF, PMF, risk management files, and QMS documents.
4. Schedule Testing: Coordinate with CDSCO-approved labs early.
5. Submit Application: Use the CDSCO MD Online Portal for seamless application submission.
6. Prepare for Audit: Engage a notified body from the Notified Bodies List and complete audit requirements.
7. Respond Promptly: Address all queries from CDSCO inspectors without delay.

By following this structured approach, manufacturers and importers of the Biliary Stone Retrieval Basket can confidently navigate CDSCO licensing, ensuring compliance and faster market entry in India.

For personalized guidance and comprehensive regulatory support, contact our expert team specialized in medical device licensing in India.