CDSCO License for Perfusion Catheter

Introduction to Perfusion Catheter and Its Regulatory Importance

Perfusion catheters are critical medical devices used during coronary interventions to enable localized drug delivery directly into the vessel wall at low pressure. Given their invasive nature and direct interaction with cardiovascular tissue, perfusion catheters are classified as Class D medical devices under the Indian CDSCO regulations. This is the highest risk category, reflecting the device's critical role and potential patient risk if not manufactured or imported following stringent quality and safety standards.

Navigating the regulatory landscape for such devices in India demands precise understanding and adherence to CDSCO licensing procedures. Our 25+ years of experience in medical device regulatory consultancy has empowered over 500 manufacturers and importers to successfully obtain their CDSCO licenses, particularly for Class D devices like perfusion catheters. In this guide, we’ll walk you through the detailed regulatory framework, specific license requirements, timelines, costs, and practical insights to streamline your market entry.

CDSCO Regulatory Framework for Perfusion Catheters

The Central Drugs Standard Control Organization (CDSCO) governs the regulation of medical devices in India. Perfusion catheters fall under Class D, the highest risk category, due to their invasive use in cardiovascular procedures. Regulatory oversight for Class D devices is managed by the Central Licensing Authority.

Key regulations concerning perfusion catheters include the notification 29/Misc/3/2017-DC (292) dated 06.06.2018, which formally classifies catheters and outlines the compliance requirements. Compliance ensures patient safety, efficacy, and alignment with international standards like ISO 13485:2016.

Risk Classification and License Requirements for Perfusion Catheters

Perfusion catheters, as Class D devices, require stringent regulatory control, including:

• Manufacturing License (MD9 License): Issued by the Central Licensing Authority.
• Import License (MD15 License): Also issued by the Central Licensing Authority for imported devices.

Class D devices are subjected to rigorous testing, quality system audits, and compliance verification before license grant. The regulatory pathway is longer and more involved than for lower-risk devices.

For more on device classification, refer to our comprehensive Medical Device Classification guide.

Manufacturing License Process (MD9 License) for Perfusion Catheters

Obtaining the MD9 license for manufacturing perfusion catheters involves several sequential steps:

1. Test License (Form MD13): The initial step requires applying for a test license to manufacture limited quantities for testing purposes. This phase typically takes 1.5 to 2 months.

2. Product Testing: Perfusion catheters must undergo testing at CDSCO-approved government laboratories to validate safety and performance. Testing duration varies but generally aligns with the test license timeframe.

3. Documentation Preparation: Comprehensive technical documentation including Device Master File, Plant Master File, Risk Management File, Essential Principles Checklist, and Quality Management System (QMS) documents must be prepared meticulously.

4. Application Submission (Form MD7): After successful testing, submit the manufacturing license application through the CDSCO MD Online Portal.

5. Audit by CDSCO Inspectors: A detailed audit of manufacturing facilities, quality systems, and documentation is conducted.

6. Query Resolution: Address any clarifications or deficiencies raised during the audit or application review.

7. License Grant (Form MD9): Upon satisfactory compliance, the MD9 license is granted.

Typically, the entire process from test license to final manufacturing license issuance takes 4 to 5 months.

For an in-depth walkthrough, see our MD9 License Guide.

Manufacturing License Documents Required for Perfusion Catheters

For Class D perfusion catheter manufacturing licenses, CDSCO mandates the following documentation:

• Company Constitution and Incorporation Certificates
• Proof of Ownership or Lease Agreement of Manufacturing Premises
• Technical Staff Qualifications and Experience Details
• Fire Safety and Pollution Control NOCs
• Device Master File (DMF) detailing design, materials, and specifications (Device Master File Guide)
• Plant Master File outlining manufacturing processes and equipment (Plant Master File Guide)
• Essential Principles Checklist confirming compliance with Indian Medical Device Rules
• Risk Management File following ISO 14971 standards (Risk Management Guide)
• Test Reports from CDSCO-approved laboratories (Testing Laboratories)
• Product Labels and Instructions for Use (IFU)
• Quality Management System Documents (e.g., ISO 13485:2016 certification)

Ensuring completeness and accuracy in these documents significantly reduces review times and audit queries.

Import License Process (MD15 License) for Perfusion Catheters

For importing perfusion catheters into India, the MD15 import license process is governed centrally and involves:

1. Documentation Preparation: Compile all required documents including manufacturing licenses, Free Sale Certificates, ISO and CE certificates, Device and Plant Master Files.

2. Application Submission (Form MD14): Submit your import license application via the CDSCO MD Online Portal.

3. Query Resolution: Respond promptly to any departmental queries.

4. License Grant (Form MD15): Upon compliance confirmation, CDSCO issues the import license.

The import license process generally takes 5 to 6 months.

Refer to our detailed Import License Guide for step-by-step assistance.

Import License Documents Required for Perfusion Catheters

To successfully apply for the MD15 import license, prepare the following:

• Valid Manufacturing License (MD9) from the country of origin
• Free Sale Certificate from the exporting country
• ISO 13485:2016 Certification
• CE Certificate or equivalent quality marking
• Device Master File and Plant Master File
• Wholesale License (if applicable)
• Company Constitution and Incorporation Certificates

Thorough documentation expedites license processing and avoids delays.

Timeline and Processing Duration

Timely submission of complete documents and proactive query resolution can accelerate these timelines.

Government Fees and Costs

• MD9 Manufacturing License:

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

• MD15 Import License (Approximate in INR based on USD rates):

  • Class D Devices:
    • Site Fee: ₹225,000 (approx $3,000)
    • Per Product Fee: ₹112,500 (approx $1,500)

Budgeting for these fees early helps in financial planning.

Common Challenges and Solutions

Challenge 1: Incomplete or inconsistent documentation leading to application rejection or delays.

Solution: Maintain a robust document management system and conduct internal audits before submission.

Challenge 2: Delays in product testing due to laboratory backlogs.

Solution: Schedule testing well in advance and select laboratories from the official CDSCO-approved Testing Laboratories list.

Challenge 3: Audit non-compliance due to inadequate QMS or facility standards.

Solution: Engage with experienced notified bodies and conduct pre-audit readiness assessments. Review the list of notified bodies for audit partners.

Challenge 4: Prolonged query resolution due to unclear responses.

Solution: Provide clear, detailed, and evidence-backed responses to CDSCO queries promptly.

Expert Consultation and Support

Navigating the CDSCO licensing maze requires technical expertise and regulatory know-how. With over 25 years of experience and over 500 successful client projects, we provide tailored consultancy services covering documentation, testing coordination, audit preparation, and application submission. Our proactive approach ensures faster approvals and compliance confidence.

Getting Started with Your CDSCO License Application for Perfusion Catheters

1. Preliminary Assessment: Confirm device classification and applicable regulations.
2. Document Compilation: Prepare all mandatory documents including Device and Plant Master Files, risk management documentation, and licensing forms.
3. Testing Coordination: Engage with CDSCO-approved laboratories early to schedule product testing.
4. Test License Application: Apply for test license (Form MD13) through the CDSCO MD Online Portal.
5. Quality System Preparation: Ensure ISO 13485:2016 compliance and readiness for audit.
6. Submit Manufacturing License Application: After testing, apply for MD9 license (Form MD7).
7. Audit and Follow-Up: Prepare for CDSCO inspections and resolve any queries diligently.

For importers, initiate document collection and apply for MD15 license through the same online portal.

Taking these decisive steps with expert guidance can significantly reduce time-to-market and regulatory risks for your perfusion catheter products in India.