CDSCO License for Negative-pressure ventilator
Medical Device Information
Intended Use
An automatic cycling machine used to assist or control alveolar respiration that exerts a negative pressure on the external surface of the chest wall, expanding the chest and moving air into the lungs.
Comprehensive Guide to CDSCO Licensing for Negative-Pressure Ventilators (Class C Medical Device)
As specialists with over 25 years of experience in medical device regulatory affairs, we have successfully guided more than 500 companies through the complex landscape of CDSCO licensing. This page focuses on the negative-pressure ventilator, a Class C anesthesiology device regulated under the CDSCO notification 29/Misc/03/2020-DC(177) dated 12.07.2021.
Introduction: Understanding Negative-Pressure Ventilators and Their Regulatory Importance
Negative-pressure ventilators are critical respiratory support devices designed to assist or control alveolar respiration by exerting negative pressure externally on the chest wall. Given their vital role in patient care, especially in anesthesiology and respiratory therapy, regulatory oversight ensures safety, efficacy, and quality before these devices enter the Indian market.
Obtaining the correct CDSCO license is mandatory for manufacturing or importing such devices. Failure to comply can result in regulatory action, market denial, or product recalls.
CDSCO Regulatory Framework for Negative-Pressure Ventilators
The Central Drugs Standard Control Organization (CDSCO) regulates medical devices under the Medical Device Rules, 2017. Devices are classified based on risk, with Class C devices considered moderate-to-high risk, necessitating stringent controls.
For negative-pressure ventilators:
- Risk Class: C
- Regulatory Authority: Central Licensing Authority (CDSCO HQ)
- Applicable License: Manufacturing License MD9 (Form MD7) or Import License MD15 (Form MD14)
Risk Classification and License Requirements for Class C Devices
Being a Class C device, negative-pressure ventilators require:
- A Manufacturing License (MD9) if produced domestically.
- An Import License (MD15) if sourced internationally.
Both licenses are issued by CDSCO's Central Licensing Authority, reflecting the higher scrutiny due to the device's critical function.
Manufacturing License Process (MD9) for Negative-Pressure Ventilators
The MD9 license process is comprehensive and typically spans 4-5 months, involving the following steps:
- Test License (MD13) Application: Before full manufacturing license, obtain a test license to produce samples for testing. This takes approximately 1.5-2 months.
- Product Testing: Conduct mandatory product testing at CDSCO-recognized laboratories. Testing validates compliance with Indian and international standards.
- Documentation Preparation: Prepare a robust dossier including technical files, risk management, and quality systems.
- License Application (Form MD7): Submit the complete application via the CDSCO MD Online Portal.
- Inspection and Audit: CDSCO inspectors conduct an on-site audit of your manufacturing facility.
- Query Resolution: Address any observations or queries raised by the department or inspectors promptly.
- License Grant: Upon satisfactory review, the MD9 license is granted.
For detailed guidance, refer to our MD9 License Guide.
Manufacturing License Documents Required for MD9
The documentation package for applying includes:
- Company Constitution (Incorporation Certificate, MOA/AOA)
- Proof of Ownership or Lease Agreement of Manufacturing Premises
- Details and qualifications of Technical Staff
- Fire NOC and Pollution Control Board NOC
- Device Master File (Technical Specifications, Design, Manufacturing Process) – see our Device Master File Guide
- Plant Master File (Facility Details, Equipment, QMS) – explore our Plant Master File Guide
- Essential Principles Checklist demonstrating compliance with safety and performance requirements
- Risk Management File (per ISO 14971) – more on Risk Management
- Test Reports from CDSCO-approved testing laboratories (Testing Laboratories List)
- Product Labeling and Instructions for Use (IFU)
- Quality Management System Documents (e.g., ISO 13485:2016 certification)
Import License Process (MD15) for Negative-Pressure Ventilators
For importers, the MD15 license process typically takes 5-6 months and includes:
- Document Preparation: Assemble comprehensive documentation including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device and Plant Master Files.
- Application Submission: Apply on the CDSCO MD Online Portal using Form MD14.
- Review and Queries: Respond to any queries raised by CDSCO officials.
- License Issuance: Upon satisfactory evaluation, the import license is granted.
Refer to our expert Import License Guide for detailed steps.
Import License Documents Required for MD15
The essential documents include:
- Valid Manufacturing License from the country of origin
- Free Sale Certificate issued by the regulatory authority of exporting country
- ISO 13485:2016 Certificate
- CE Certificate or equivalent
- Device Master File and Plant Master File
- Wholesale License for distribution in India
- Company Constitution documents
- Application Form MD14
Timeline and Processing Duration
| Process Step | Approximate Duration |
|---|---|
| Test License (MD13) | 1.5 to 2 months |
| Product Testing | 1 to 1.5 months |
| Documentation Preparation | 1 month (parallel process) |
| Application Review & Audit | 1.5 to 2 months |
| Total Time (Manufacturing) | 4 to 5 months |
| Total Time (Import) | 5 to 6 months |
Timelines can vary based on application completeness and responsiveness to queries.
Government Fees and Costs
Manufacturing License (MD9) Fees:
- Application Fee: INR 50,000
- Per Product Fee: INR 1,000
Import License (MD15) Fees for Class C Devices:
- Site Fee: USD 3,000
- Per Product Fee: USD 1,500
Additional costs include product testing fees, notified body audit fees, and professional consultancy if required.
Common Challenges and Solutions
Challenge: Delays due to incomplete documentation or inadequate technical files.
- Solution: Utilize our detailed checklists and templates to prepare comprehensive dossiers.
Challenge: Difficulty in selecting a notified body for audits.
- Solution: Reference the official Notified Bodies List to identify authorized agencies.
Challenge: Product testing turnaround time.
- Solution: Engage early with CDSCO-approved labs and plan testing parallel to documentation.
Challenge: Responding to audit and CDSCO queries.
- Solution: Maintain clear internal communication and expert regulatory support to provide timely, accurate responses.
Expert Consultation and Support
Navigating CDSCO licensing for Class C devices like negative-pressure ventilators requires precision and expertise. Our seasoned regulatory consultants provide end-to-end support— from dossier preparation, liaison with CDSCO, audit coordination, to post-approval compliance.
With a proven track record assisting over 500 companies, we help minimize delays, reduce rejections, and ensure a smooth pathway to market entry.
Getting Started with Your CDSCO License Application
- Initial Assessment: Verify your device classification and applicable licensing requirements by reviewing the Medical Device Classification guide.
- Plan Your Timeline: Account for test license, testing, documentation, and audit phases.
- Prepare Documentation: Leverage our Device Master File and Plant Master File guides to compile required files meticulously.
- Register on CDSCO Portal: Submit your application and monitor status via the CDSCO MD Online Portal.
- Engage Experts: Consider partnering with experienced consultants to navigate technical and regulatory challenges effectively.
Embarking on your CDSCO licensing journey equipped with expert knowledge ensures timely approval and successful market access for your negative-pressure ventilator in India. Contact us today to begin your compliance roadmap with confidence.
