CDSCO License for Wire

Comprehensive CDSCO Licensing Guide for Esophageal Stent Wires (Class C Catheters)

Entering the Indian medical device market with a Class C device such as an esophageal stent wire requires navigating the Central Drugs Standard Control Organization (CDSCO) regulatory framework meticulously. With over 25 years of experience and having supported 500+ companies, we understand the complexities involved and provide you with an actionable roadmap to secure your CDSCO license efficiently.

Understanding the Device: Esophageal Stent Wire

An esophageal stent wire is a crucial catheter device designed to maintain patency in a blocked esophagus, enabling patients to swallow soft foods and liquids comfortably. Classified under risk Class C, this device demands rigorous regulatory compliance due to its invasive nature and critical application in patient care.

CDSCO Regulatory Framework for Class C Catheters

Under the Medical Device Rules, 2017, Class C devices fall under moderate to high risk, necessitating a centralized licensing approach via the CDSCO Central Licensing Authority. The regulatory pathway involves obtaining an MD9 manufacturing license if you intend to manufacture in India or an MD15 import license if you plan to import.

Risk Classification and Licensing Requirements for Esophageal Stent Wire

• Risk Class: C (Moderate to high risk)
• Regulatory Compliance: MD9 Manufacturing License for manufacturers; MD15 Import License for importers
• Notification: 29/Misc/3/2017-DC (292), dated 06.06.2018

MD9 Manufacturing License Process for Class C Devices

Securing an MD9 license is a multi-step process overseen by CDSCO’s Central Licensing Authority. The overall timeline is approximately 4-5 months.

Step 1: Test License (Form MD13)

• Apply for a test license allowing product testing.
• Processing time: 1.5 to 2 months.

Step 2: Product Testing

• Conduct mandatory testing at one of the CDSCO-approved testing laboratories.
• Testing parameters include biocompatibility, sterilization validation, mechanical integrity, and labeling compliance.

Step 3: Document Preparation

• Prepare comprehensive documentation including Device Master File (DMF), Plant Master File (PMF), Essential Principles Checklist, Risk Management File, Test Reports, and Quality Management System (QMS) documents.
• For detailed guidance, refer to our Device Master File guide and Plant Master File guide.

Step 4: License Application (Form MD7)

• Submit the MD9 license application through the CDSCO MD Online Portal along with all supporting documents.

Step 5: CDSCO Inspection and Audit

• CDSCO inspectors conduct an on-site audit to verify compliance with GMP and QMS.
• Prepare for audit by thoroughly reviewing all documentation and ensuring operational readiness.

Step 6: Query Resolution

• Respond promptly and comprehensively to any queries from CDSCO or auditors.

Step 7: Grant of License

• Upon satisfactory review and inspection, CDSCO grants the Manufacturing License (Form MD9).

Documents Required for MD9 License Application

• Company Constitution and Incorporation Certificates
• Ownership Proof of Manufacturing Premises
• Qualification and Experience Details of Technical Staff
• Fire NOC and Pollution Control NOC
• Device Master File (DMF) detailing design, components, and manufacturing processes
• Plant Master File (PMF) outlining facilities, equipment, and quality controls
• Essential Principles Compliance Checklist
• Risk Management File demonstrating adherence to ISO 14971 principles
• Product Test Reports from CDSCO-approved labs
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) Certificates, preferably ISO 13485:2016

Import License Process (MD15) for Esophageal Stent Wire

If you plan to import the esophageal stent wire, an MD15 license is mandatory, granted by the Central Licensing Authority, with a typical processing duration of 5-6 months.

Process Overview:

• Document preparation including Manufacturing License from the country of origin, Free Sale Certificate, CE Certificate (if applicable), DMF, PMF, Wholesale License, and Company Constitution.
• Application submission on the CDSCO MD Online Portal using Form MD14.
• Resolution of departmental queries.
• License grant (Form MD15).

Timeline and Processing Duration Summary

Government Fees and Cost Structure

For the MD9 manufacturing license for Class C devices:

• Application Fee: Rs 50,000 per application
• Per Product Fee: Rs 1,000

Testing and audit costs vary depending on the notified bodies and labs involved. It is prudent to budget for approximately Rs 2-3 lakhs covering testing and consultancy.

Common Challenges and Practical Solutions

Challenge 1: Delays in Product Testing

• Solution: Engage with CDSCO-approved testing laboratories early. Pre-book slots to avoid bottlenecks.

Challenge 2: Documentation Gaps

• Solution: Develop your Device Master File and Plant Master File meticulously. Use our comprehensive guides for accuracy.

Challenge 3: Audit Non-Compliance

• Solution: Conduct mock audits and gap analysis before the official inspection.

Challenge 4: Query Resolution Delays

• Solution: Assign a dedicated regulatory liaison to respond promptly to CDSCO queries.

Expert Consultation and Support

Navigating CDSCO regulations for Class C medical devices like esophageal stent wires demands specialized expertise. Our experienced regulatory consultants have a proven track record of facilitating seamless license approvals for over 500 companies. We offer end-to-end support—from document preparation and audit readiness to liaising with CDSCO authorities.

Getting Started with Your CDSCO License Application

1. Assess Device Classification: Confirm your device is Class C as per CDSCO guidelines.
2. Prepare Initial Documentation: Compile company credentials, technical staff details, and premises proofs.
3. Apply for Test License (MD13): Submit application via the CDSCO MD Online Portal.
4. Schedule Product Testing: Coordinate with approved labs to initiate compliance testing.
5. Develop DMF and PMF: Leverage our detailed guides to prepare these critical files.
6. Submit MD9 Application (Form MD7): Post testing and document finalization, apply online.
7. Prepare for CDSCO Audit: Ensure all QMS and manufacturing practices are compliant.
8. Monitor and Respond to Queries: Stay proactive in communications with CDSCO.

Embarking on this regulatory journey with a clear, practical plan significantly enhances your chances of a timely license grant, enabling you to bring your esophageal stent wire to the Indian market confidently and compliantly.

For personalized assistance and to leverage our expertise in expediting your CDSCO approvals, contact us today.