CDSCO License for Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure
Medical Device Information
Intended Use
An extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary support (>6 hours) is a system of devices and accessories that provides assisted extracorporeal circulation and physiologic gas exchange of the patient's blood in patients with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent. The main devices and accessories of the system include, but are not limited to, the console (hardware), software, and disposables, including, but not limited to, an oxygenator, blood pump, heat exchanger, cannulae, tubing, filters, and other accessories (e.g., monitors, detectors, sensors, connectors).
Introduction to Extracorporeal Circuit and Accessories for Long-Term Respiratory/Cardiopulmonary Failure
Extracorporeal circuits and accessories designed for long-term respiratory or cardiopulmonary failure represent critical, life-sustaining medical devices. These systems assist in extracorporeal circulation and physiologic gas exchange for patients with acute respiratory or cardiopulmonary failure where other treatments have failed or when imminent death is a risk. Due to the complexity and critical nature, these devices fall under Class C risk category in India’s regulatory framework, warranting stringent compliance with the Central Drugs Standard Control Organization (CDSCO) requirements.
Understanding the regulatory landscape for such advanced cardiovascular devices is vital for manufacturers and importers aiming for successful market entry and sustained compliance within India's healthcare ecosystem.
CDSCO Regulatory Framework for Class C Cardiovascular Devices
The CDSCO, under the Ministry of Health and Family Welfare, governs the approval and licensing of medical devices in India. Since the notification dated 26.07.2021 (No. 29/Misc./03/2020-DC (159)), extracorporeal circuits and accessories for long-term cardiopulmonary support have been explicitly classified under Class C devices in the cardiovascular category. This classification reflects their moderate to high risk, necessitating a centralized approval process.
Risk Classification and License Requirements for Extracorporeal Circuit Devices
The device’s classification as Class C means that the licensing process falls under the Central Licensing Authority of CDSCO. This classification mandates a more rigorous review, including detailed technical documentation, product testing, and audits.
For Class C medical devices, the applicable manufacturing license is the MD9 license, obtained via application Form MD7. This license is mandatory for manufacturing inside India, while importers must secure an MD15 import license.
For detailed understanding of medical device classification, manufacturers can refer to our comprehensive Medical Device Classification guide.
Manufacturing License Process (MD9) for Class C Devices
Obtaining an MD9 manufacturing license for devices such as extracorporeal circuits involves a multi-step process:
Test License (Form MD13): The manufacturer first applies for a test license to produce the device in limited quantities for testing purposes. The test license approval usually takes about 1.5 to 2 months.
Product Testing: Samples must be tested at CDSCO-approved government laboratories to validate safety and performance. Check the list of testing laboratories authorized for such testing.
Document Preparation: Compile comprehensive documentation, including the Device Master File and Plant Master File, essential principles checklist, risk management files, and quality management system evidence.
Submission of MD9 Application (Form MD7): File the application through the CDSCO MD Online Portal.
Audit by CDSCO Inspectors: The regulatory authority conducts an on-site audit to verify compliance with Good Manufacturing Practices (GMP) and other regulatory requirements.
Resolution of Queries: Address any observations or queries raised by CDSCO or during the audit process promptly.
Grant of Manufacturing License (Form MD9): Upon satisfactory review, the license is granted, enabling commercial manufacturing.
Manufacturers typically experience a total process duration of around 4 to 5 months, encompassing test license issuance, testing, audit, and final license grant.
For a detailed walkthrough, our MD9 License Guide provides practical insights.
Manufacturing License Documents Required for MD9
Manufacturers must prepare and submit the following key documents:
- Company Constitution: Proof of legal entity and registration.
- Proof of Ownership or Lease of Premises: Address and details of the manufacturing site.
- Technical Staff Documents: Qualifications and CVs of qualified personnel responsible for manufacturing and quality.
- Fire and Pollution NOCs: Approvals from local authorities ensuring safety and environmental compliance.
- Device Master File (DMF): Detailed device specifications, manufacturing processes, and quality controls. Learn how to prepare a DMF through our Device Master File Guide.
- Plant Master File (PMF): Documentation of the manufacturing facility and infrastructure. Our Plant Master File Guide can help streamline this process.
- Essential Principles Checklist: Compliance with Indian and international essential principles of safety and performance.
- Risk Management File: Documentation demonstrating compliance with risk management standards such as ISO 14971. Our Risk Management guide is a useful resource.
- Test Reports: Results from government-approved testing laboratories.
- Labels and Instructions for Use (IFU): Samples showing compliance with labeling regulations.
- Quality Management System (QMS) Documents: Evidence of ISO 13485 certification and internal procedures.
Import License Process (MD15) for Class C Devices
Importers seeking to bring extracorporeal circuit devices into India must apply for the MD15 license using Form MD14.
Key steps include:
Document Preparation: Assemble all required documentation including manufacturing license of the exporter, Free Sale Certificate, ISO 13485:2016 certification, CE certificate, Device and Plant Master Files, wholesale license, and company constitution.
Application Submission: File the application via the CDSCO MD Online Portal.
Departmental Review and Query Resolution: Address any questions or clarifications requested by CDSCO.
License Grant: On satisfactory review, the MD15 import license is issued.
The import license process typically takes 5 to 6 months due to thorough document verification and regulatory scrutiny.
Our Import License Guide offers detailed procedural assistance.
Import License Documents Required for MD15
- Valid Manufacturing License from Exporting Country
- Free Sale Certificate confirming marketing approval in the country of origin
- ISO 13485:2016 Certification
- CE Certificate or equivalent
- Device Master File and Plant Master File
- Wholesale License in India
- Company Constitution
- Product Labels and IFUs
Timeline and Processing Duration
| Process Step | Duration |
|---|---|
| Test License (MD13) | 1.5–2 months |
| Product Testing | 1–1.5 months |
| Document Preparation | 1 month |
| Submission & Audit | 1–1.5 months |
| Query Resolution & License | 0.5–1 month |
Total Manufacturing License (MD9) Duration: Approximately 4–5 months
Total Import License (MD15) Duration: Approximately 5–6 months
Government Fees and Costs
- MD9 Manufacturing License: INR 50,000 per application + INR 1,000 per product
- MD13 Test License: No separate fee typically; included in process
- MD15 Import License:
- Class C & D devices: USD 3,000 per site + USD 1,500 per product
These fees are payable online via the CDSCO MD Online Portal during application submission.
Common Challenges and Solutions
Delayed Audit Scheduling: Early coordination with notified bodies and CDSCO officials can mitigate delays. Check the list of notified bodies to select experienced auditors.
Incomplete Documentation: Utilize detailed checklists and consult expert regulatory advisors to ensure all files (DMF, PMF, risk management) are complete and compliant.
Testing Failures: Repeat testing may cause delays. Select accredited laboratories and engage in pre-testing validations to avoid non-conformities.
Query Resolution Delays: Assign dedicated regulatory personnel to respond promptly to CDSCO queries to keep the process on track.
Expert Consultation and Support
With over 25 years of experience and 500+ successful CDSCO licensing projects, we specialize in navigating the complexities of Class C device approvals. Our end-to-end services include document preparation, audit coordination, testing liaison, and application follow-up, ensuring a smooth pathway to market.
Getting Started with Your CDSCO License Application
- Assess Your Device Classification: Confirm your device risk class and applicable license type.
- Prepare Core Documentation: Start with your Device Master File and Plant Master File, alongside QMS and risk management files.
- Apply for Test License (MD13): Submit your test license application via the CDSCO MD Online Portal.
- Schedule Product Testing: Engage with CDSCO-approved labs early to prevent bottlenecks.
- Compile and Submit MD9 Application: Once test license and product testing are complete, apply for the manufacturing license.
- Plan for Audit: Coordinate logistics and compliance for the CDSCO inspection.
- Prepare for Query Responses: Assign a regulatory expert to manage communications.
Embarking on this process with meticulous preparation and expert guidance will facilitate timely approval and successful market access for your extracorporeal circuit and accessories in India’s dynamic healthcare market.
