CDSCO License for Funnel chest remodelling bar

Comprehensive CDSCO Licensing Guide for Funnel Chest Remodelling Bar (Class C Medical Device)

As seasoned regulatory consultants with over 25 years of experience and having successfully guided 500+ medical device companies through the CDSCO licensing maze, we understand the critical importance of compliance for implantable devices like the Funnel Chest Remodelling Bar. This device, classified as Class C due to its invasive implantable nature, plays a vital role in pediatric orthopedics by correcting pectus excavatum deformities. Navigating the regulatory framework effectively not only ensures timely market access but also builds trust with healthcare providers and patients.

CDSCO Regulatory Framework for Funnel Chest Remodelling Bar

In India, the Central Drugs Standard Control Organization (CDSCO) governs the regulation of medical devices under the Medical Device Rules, 2017. The Funnel Chest Remodelling Bar, notified under File No. 29/MiscJ03/2020-DC (150) on 23.8.2021, falls under Class C risk classification due to its invasive implantable nature and intended use in pediatric patients. This mandates a rigorous regulatory pathway through the Central Licensing Authority.

Risk Classification and License Requirements for Class C Devices

Class C devices like the Funnel Chest Remodelling Bar require an MD9 manufacturing license, issued by the CDSCO Central Licensing Authority. This classification involves moderate to high risk, necessitating stringent testing, documentation, and audits.

Key points:

• License Type: MD9 Manufacturing License (Application Form MD7)
• Licensing Authority: CDSCO Central Licensing Authority
• Timeline: Approximately 4–5 months
• Fees: Rs 50,000 per application + Rs 1,000 per product

For detailed classification understanding, manufacturers can refer to our Medical Device Classification guide.

Manufacturing License Process (MD9) for Funnel Chest Remodelling Bar

The MD9 licensing process is multi-staged and requires strategic planning:

1. Test License Acquisition (Form MD13): Initiate with a test license application, valid for product testing, which takes 1.5–2 months to be granted.
2. Product Testing: Conduct comprehensive testing at CDSCO-approved government laboratories to validate safety and performance. Refer to the list of testing laboratories for accredited facilities.
3. Document Preparation: Assemble critical documents including Device Master File, Plant Master File, Risk Management File, Essential Principles Checklist, QMS documentation, and clinical evaluation reports.
4. Application Submission: Submit the MD9 license application (Form MD7) through the CDSCO MD Online Portal.
5. Audit by CDSCO Inspectors: Post submission, CDSCO conducts a detailed audit of manufacturing premises, quality systems, and technical personnel.
6. Query Resolution: Address any queries raised by the department or audit team promptly to avoid delays.
7. License Grant: Upon satisfactory audit and document verification, the MD9 license is granted (Form MD9).

Manufacturing License Documents Required for MD9

To ensure a smooth application process, meticulous document preparation is essential. The following documentation is mandatory:

• Company constitution and incorporation certificates
• Proof of ownership or lease of manufacturing premises
• Credentials and qualifications of technical and managerial staff
• Fire safety and pollution control clearances (NOCs)
• Device Master File detailing design, materials, and manufacturing processes (Device Master File guide)
• Plant Master File describing the manufacturing facility and quality management systems (Plant Master File guide)
• Essential Principles Checklist demonstrating compliance with Indian and international standards
• Risk Management File that addresses device-specific hazards (Risk Management)
• Test reports from CDSCO-approved labs
• Product labels and Instructions for Use (IFU)
• Quality Management System documents (ISO 13485:2016 certification preferred)

Import License Process (MD15) for Funnel Chest Remodelling Bar

If you plan to import this device into India, an MD15 import license issued by the Central Licensing Authority is mandatory. The process includes:

• Document preparation including existing manufacturing license, Free Sale Certificate, ISO and CE certifications
• Application on Form MD14 submitted via the CDSCO MD Online Portal
• Queries and clarifications with CDSCO
• Final license grant (Form MD15)

The import license timeline is typically 5–6 months. Fees vary by device class and quantity; for Class C devices, government fees are approximately $3,000 per site and$1,500 per product.

For a detailed walkthrough, see our Import License guide.

Timeline and Processing Duration Summary

Government Fees and Costs

• MD9 License Application Fee: Rs 50,000 per application
• Per Product Fee: Rs 1,000
• Test License Fee (MD13): Nominal, as per CDSCO norms
• Additional costs include product testing fees, notified body audit charges, and consulting fees if applicable.

Common Challenges and Practical Solutions

Challenge 1: Delays in Product Testing

• Solution: Engage early with notified testing labs and schedule testing well in advance. Maintain clear communication to expedite testing.

Challenge 2: Incomplete Documentation

• Solution: Use comprehensive checklists and templates. Our Device Master File and Plant Master File guides can streamline document preparation.

Challenge 3: Audit Non-compliance

• Solution: Conduct internal audits and mock inspections before CDSCO visits. Train your technical staff on regulatory expectations.

Challenge 4: Query Resolution Delays

• Solution: Assign dedicated resources to respond quickly and accurately to CDSCO queries.

Expert Consultation and Support

Navigating regulatory compliance for Class C implantable devices is complex and demands expert guidance. We offer customized consultancy encompassing document preparation, liaison with CDSCO, audit readiness, and post-license compliance support. Our track record of successfully obtaining licenses for over 500 companies ensures you avoid common pitfalls and accelerate your time to market.

Getting Started with Your CDSCO License Application for Funnel Chest Remodelling Bar

1. Evaluate Your Product Classification: Confirm the Class C status and intended use.
2. Initiate Test License Application: Prepare and submit Form MD13 via the CDSCO MD Online Portal to commence product testing.
3. Engage Accredited Testing Labs: Select appropriate government-approved labs from the CDSCO Testing Laboratories list for thorough product evaluation.
4. Compile Comprehensive Documentation: Use our expert guides to develop your Device Master File, Plant Master File, and Risk Management documentation.
5. Submit MD9 License Application: After testing and documentation, apply on the portal using Form MD7.
6. Prepare for CDSCO Audit: Ensure your facility and QMS comply with CDSCO standards; consider mock audits to identify gaps.
7. Respond to Queries Promptly: Assign a dedicated team to handle correspondence efficiently.
8. Obtain License and Commence Manufacturing: Once granted, maintain compliance through periodic audits and documentation updates.

By following these actionable steps, manufacturers and importers can confidently navigate the CDSCO licensing process for the Funnel Chest Remodelling Bar and successfully bring this life-enhancing device to the Indian market.

For specialized assistance with your application, please contact our regulatory experts who are ready to support you throughout the licensing journey.