CDSCO License for Intravascular membrane oxygenator

Comprehensive Guide to CDSCO Licensing for Intravascular Membrane Oxygenators (Class C Medical Device)

Intravascular membrane oxygenators play a critical role in anesthesiology by providing temporary respiratory support for adults suffering from respiratory distress syndrome. This advanced medical device facilitates the diffusion of oxygen and carbon dioxide across a gas-permeable implantable membrane, primarily targeting failing lungs. Given its high-risk classification (Class C), strict adherence to the Central Drugs Standard Control Organization (CDSCO) regulatory framework is essential to legally manufacture or import this device in India.

With over 25 years of experience assisting 500+ medical device companies, we offer you a detailed roadmap for obtaining your CDSCO licenses efficiently and compliantly.

CDSCO Regulatory Framework for Intravascular Membrane Oxygenators

As a Class C device under the anesthesiology category, the intravascular membrane oxygenator is subject to rigorous regulatory controls. The CDSCO mandates that manufacturers obtain an MD9 license, while importers must secure an MD15 license before marketing this device in India. The classification and associated licensing requirements are derived from the notification 29/Misc/03/2020-DC(177), dated 12.07.2021.

Understanding these regulatory nuances is crucial because Class C devices involve moderate to high risk, necessitating centralized regulatory oversight from CDSCO's central licensing authority.

Risk Classification and License Requirements

• Risk Class: C (Moderate to high risk)
• Manufacturing License: MD9 (Application Form MD7) issued by CDSCO Central Licensing Authority
• Import License: MD15, also granted by the CDSCO Central Authority

This classification determines the depth of scrutiny, documentation, product testing, and audit processes your application will undergo.

Manufacturing License Process (MD9) for Class C Devices

1. Test License (Form MD13):
   • Prior to the manufacturing license application, you must obtain a test license on Form MD13. This allows sample testing of your device.
   • Processing time: Approximately 1.5 to 2 months.
2. Product Testing:
   • Conduct product testing at government-approved testing laboratories to validate safety and efficacy.
   • Refer to the official Testing Laboratories list.
3. Documentation Preparation:
   • Compile comprehensive technical dossiers including Device Master File (DMF), Plant Master File (PMF), and risk management documentation.
4. Application Submission:
   • Submit your MD9 manufacturing license application via the CDSCO MD Online Portal using Form MD7.
5. Audit by CDSCO Inspectors:
   • The CDSCO will conduct an on-site audit of your manufacturing facility.
6. Resolution of Queries:
   • Address any deficiencies or questions raised by the regulatory authority or inspectors.
7. Grant of License:
   • Upon successful review, an MD9 license will be issued.

For a detailed breakdown, consult our MD9 License Guide.

Manufacturing License Documents Required for MD9

• Company Constitution and Incorporation Certificates
• Proof of Ownership or Lease Agreement for Manufacturing Premises
• Qualifications and Experience Certificates of Technical Staff
• Fire No Objection Certificate (NOC)
• Pollution Control Board NOC
• Device Master File (DMF): Detailed design, specifications, and manufacturing process descriptions (Learn more)
• Plant Master File (PMF): Manufacturing facility details, equipment, and quality systems (Learn more)
• Essential Principles Checklist confirming compliance with Indian regulations
• Risk Management File outlining hazard analysis and mitigation strategies (Risk Management Guide)
• Product Test Reports from CDSCO-approved labs
• Labels and Instructions For Use (IFU)
• Quality Management System (QMS) documents, preferably ISO 13485:2016 certification

Import License Process (MD15) for Class C Devices

1. Documentation Preparation:
   • Gather all necessary import documentation including manufacturing and quality certificates.
2. Application Submission:
   • Apply for the MD15 import license through the CDSCO MD Online Portal using Form MD14.
3. Queries Resolution:
   • Respond promptly to any queries raised by CDSCO.
4. License Grant:
   • Receive your import license on Form MD15.

Unlike manufacturing, no test license is required before applying for an import license.

Import License Documents Required for MD15

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

For a comprehensive breakdown, visit our Import License Guide.

Timeline and Processing Duration

Timelines can vary depending on document readiness and audit scheduling. Early and thorough preparation significantly mitigates delays.

Government Fees and Costs

*Import fees are calculated based on USD exchange rates (Class C & D: $3000 per site +$1500 per product).

Additional costs include testing fees, audit fees (if outsourced), and consultant fees if applicable.

Common Challenges and Solutions

• Challenge: Delays in Product Testing
  • Solution: Engage early with CDSCO-approved labs; prioritize scheduling and sample submission.
• Challenge: Incomplete or Inadequate Documentation
  • Solution: Use checklists based on CDSCO guidelines and expert consultation to ensure completeness.
• Challenge: Audit Non-Conformities
  • Solution: Conduct internal audits and pre-assessment reviews ahead of CDSCO inspection.
• Challenge: Communication Gaps with CDSCO
  • Solution: Maintain proactive follow-ups via the CDSCO MD Online Portal and timely responses to queries.

Expert Consultation and Support

Navigating CDSCO licensing for Class C devices like intravascular membrane oxygenators can be complex. Our specialized regulatory consultancy offers:

• Tailored dossier preparation
• Assistance with test license and product testing coordination
• Audit readiness and mock inspections
• Query response drafting and submission
• End-to-end application tracking on the CDSCO MD Online Portal

Our proven track record with over 500 successful CDSCO licensing projects ensures your compliance journey is smooth and efficient.

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm the Class C status and applicable licensing route.
2. Initiate Test License Application: Submit Form MD13 to obtain the test license.
3. Engage Testing Laboratories: Send device samples to CDSCO-approved labs early to avoid bottlenecks.
4. Prepare Comprehensive Documentation: Leverage our Device Master File and Plant Master File guides.
5. Submit Manufacturing License Application: Apply via Form MD7 on the CDSCO MD Online Portal.
6. Prepare for Audit: Conduct internal readiness assessments and ensure compliance.
7. Respond Promptly to CDSCO Queries: Timely communication expedites license grant.

By following this structured approach, you position your intravascular membrane oxygenator for timely market entry while maintaining full regulatory compliance.

For personalized assistance and detailed project planning, connect with our expert team today.