CDSCO License for Collagen-containing peritoneum  absorbable catheter cuff

Introduction to Collagen-containing Peritoneum Absorbable Catheter Cuff and Regulatory Importance

The collagen-containing peritoneum absorbable catheter cuff is a specialized medical device designed for nephrology and renal care. It consists of a biodegradable porous material embedded with collagen, intended for subcutaneous implantation at the outlet of peritoneal dialysis catheters. Given its critical role in patient care and its classification as a Class D device, obtaining the appropriate CDSCO license is paramount for manufacturers and importers to legally market and distribute this device in India.

With over 25 years of experience and having assisted more than 500 companies in navigating the CDSCO licensing landscape, we understand the intricacies involved in securing the MD9 license for this high-risk device. This comprehensive guide details the regulatory framework, documentation, timelines, costs, and practical tips tailored specifically for collagen-containing peritoneum absorbable catheter cuffs.

CDSCO Regulatory Framework for Collagen-containing Peritoneum Absorbable Catheter Cuff

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India under the Medical Device Rules, 2017. Devices are classified into four risk classes: A, B, C, and D, with Class D representing the highest risk category. Our device falls under Class D due to its implantable nature and critical application in peritoneal dialysis.

The device is notified under the reference number 29/Misc./03/2020-DC (143) dated 13.9.2021, which confirms its regulated status requiring a Central Licensing Authority (CLA) approval for manufacturing and import.

Risk Classification and License Requirements

• Device Risk Class: D (High risk)
• Regulatory Requirement: MD9 Manufacturing License (Application Form MD7)
• Authority: Central Licensing Authority (CDSCO New Delhi)

Class D devices require stringent scrutiny, including mandatory testing, audit by CDSCO inspectors, and compliance with comprehensive documentation standards.

Manufacturing License Process (MD9)

The manufacturing license process for Class D devices like the collagen-containing peritoneum absorbable catheter cuff involves multiple stages:

1. Test License Application (Form MD13): Initial approval to begin product testing; takes approximately 1.5 to 2 months.
2. Product Testing: Conducted at CDSCO-approved government laboratories to verify safety and efficacy.
3. Document Preparation: Compilation of technical dossiers, Device Master File (DMF), Plant Master File (PMF), Risk Management File, and other requisite documents.
4. Submission of Application (Form MD7): Formal application for MD9 license through the CDSCO MD Online Portal.
5. Audit/Inspection: Conducted by CDSCO inspectors at the manufacturing site to verify compliance with QMS and regulatory requirements.
6. Query Resolution: Addressing any observations or queries raised during audit or review.
7. Grant of License (Form MD9): Upon satisfactory review, CDSCO issues the manufacturing license.

For an average timeline, expect around 4 to 5 months from test license application to final license grant.

Manufacturing License Documents Required

For the MD9 license, the following documents must be meticulously prepared and submitted:

• Company Constitution and Incorporation Certificates
• Proof of Ownership or Lease of Manufacturing Premises
• Qualification and Experience Documents of Technical Staff
• Fire Safety NOC and Pollution Control Board NOC
• Device Master File (DMF): Detailed device specifications, manufacturing processes, and control measures. Our comprehensive Device Master File guide can assist in preparation.
• Plant Master File (PMF): Description of the manufacturing facility and quality systems. Learn more from our Plant Master File guide.
• Essential Principles Compliance Checklist
• Risk Management File demonstrating compliance with ISO 14971 standards. Explore Risk Management best practices.
• Test Reports from CDSCO-approved laboratories (Testing Laboratories List)
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) Documents, preferably ISO 13485:2016 certified

Import License Process (MD15)

If you plan to import the collagen-containing peritoneum absorbable catheter cuff into India, an MD15 import license from the CDSCO Central Licensing Authority is mandatory.

The import license process involves:

1. Document Preparation: Including Manufacturing License from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate (if applicable), DMF, PMF, Wholesale License, and Company Constitution.
2. Application Submission: Via the CDSCO MD Online Portal using Form MD14.
3. Review and Query Resolution: CDSCO reviews the application and may raise queries.
4. Grant of Import License (Form MD15): License issued after compliance.

Typical processing time is approximately 5 to 6 months.

Import License Documents Required

Specific documents include:

• Valid Manufacturing License from the country of manufacture
• Free Sale Certificate or Certificate of Market Authorization
• ISO 13485:2016 Certification
• CE Marking Certificate (if applicable)
• Device Master File and Plant Master File
• Wholesale License for import and distribution
• Company Constitution and Incorporation Certificates

Timeline and Processing Duration

Total expected duration: 4 to 5 months for manufacturing license.

For import license, expect 5 to 6 months.

Government Fees and Costs

For the collagen-containing peritoneum absorbable catheter cuff (Class D device), fee structure is as follows:

• MD9 Manufacturing License:

  • Application Fee: ₹50,000
  • Per Product Fee: ₹1,000

• MD15 Import License:

  • Site Fee: USD 3,000
  • Per Product Fee: USD 1,500

Additional costs include laboratory testing fees, notified body audit charges, and consultant fees (if applicable).

Common Challenges and Solutions

Challenge: Delays in test license approval and product testing.

• Solution: Engage early with CDSCO-approved testing laboratories and prepare complete test samples and documentation to avoid back-and-forth.

Challenge: Incomplete or inconsistent documentation leading to queries.

• Solution: Utilize expert consultants to cross-verify document completeness, especially DMF, PMF, Risk Management File, and QMS documentation.

Challenge: Audit non-compliance issues.

• Solution: Conduct internal pre-audit assessments and train personnel on regulatory requirements to ensure smooth CDSCO inspections.

Expert Consultation and Support

Navigating the complexities of Class D device licensing is challenging without expert guidance. We offer end-to-end support—from gap analysis, documentation preparation, coordination with notified bodies, to post-approval compliance.

Our proven methodology has successfully enabled over 500 companies to obtain their CDSCO licenses efficiently. We also assist with regulatory updates and compliance audits to ensure sustained market access.

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm your device’s Class D status on the Medical Device Classification resource.
2. Prepare Test License (MD13) Application: Submit initial application on the CDSCO MD Online Portal.
3. Engage with CDSCO-Approved Testing Labs: Identify suitable laboratories from the official Testing Laboratories list to initiate product testing.
4. Compile Comprehensive Documentation: Develop your Device Master File, Plant Master File, Risk Management File, and QMS documents.
5. Apply for MD9 License (Form MD7): After successful testing, submit your manufacturing license application online.
6. Prepare for Audit: Coordinate with CDSCO inspectors and respond promptly to any queries.

Starting early and systematically following these steps will streamline your CDSCO licensing process for the collagen-containing peritoneum absorbable catheter cuff.

For personalized assistance and to leverage our 25+ years of expertise, contact us today and ensure a smooth regulatory journey into the Indian medical device market.