CDSCO License for Ventilator, software
Medical Device Information
Intended Use
A data program designed for use in, or together with, a ventilator allowing it to function according to the intended purpose. The software can be installed, or exchanged as an upgrade.
Comprehensive Guide to CDSCO Licensing for Class C Ventilator Software
Ventilator software plays a critical role in respiratory care, enabling ventilators to operate safely and effectively. Given its classification as a Class C medical device software by CDSCO, manufacturers and importers must navigate stringent regulatory pathways to ensure compliance and market access in India. With over 25 years of expertise supporting 500+ companies in securing CDSCO licenses, we provide a detailed, practical roadmap to obtaining your manufacturing and import licenses for ventilator software.
CDSCO Regulatory Framework for Ventilator Software (Class C)
Ventilator software, designed to function in conjunction with physical ventilators, is regulated as a Class C device under the Medical Devices Rules, 2017. This classification reflects its moderate to high risk, as any malfunction can significantly impact patient safety.
Per the Medical Device Classification guidelines, Class C devices require central licensing authority approval through the MD9 license for manufacturing and MD15 license for import.
The relevant CDSCO notification for ventilator software is 29/Misc./03/2020-DC (198), dated 13th September 2021, which formally recognizes software-only devices under this regulatory framework.
Risk Classification and License Requirements for Ventilator Software
- Risk Class: C (Moderate to High Risk)
- License Type for Manufacturing: MD9 (Application Form MD7)
- License Type for Import: MD15 (Application Form MD14)
- Licensing Authority: Central Licensing Authority (CDSCO Headquarters)
Class C designation mandates a comprehensive evaluation including product testing, quality management system (QMS) audits, and conformity with essential principles.
Manufacturing License Process (MD9) for Ventilator Software
Securing an MD9 license involves multiple sequential steps:
Test License Application (Form MD13): Before full manufacturing approval, apply for a test license to facilitate sample testing. This typically takes 1.5 to 2 months.
Product Testing: Get the ventilator software tested at CDSCO-approved laboratories to validate safety and performance. Approved testing labs can be found on the CDSCO Testing Laboratories list.
Document Preparation: Compile detailed technical documentation, including Device Master File, Plant Master File, Risk Management File, and Essential Principles Checklist.
Submission of MD9 Application (Form MD7): Submit your completed application via the CDSCO MD Online Portal including all supporting documents.
Audit by CDSCO Inspectors: A thorough audit of manufacturing facilities, QMS, and documentation is conducted.
Resolution of Queries: Address any clarifications or deficiencies raised by the CDSCO or auditors.
Grant of MD9 License (Form MD9): Upon satisfactory review, the license is issued, permitting manufacturing and sale in India.
Manufacturing License Documents Required for Ventilator Software
For Class C ventilator software, ensure the following documentation is meticulously prepared:
- Company Constitution (Incorporation Certificate, MOA/AOA)
- Proof of Ownership or Lease of Manufacturing Premises
- Technical Staff Qualifications and Experience Records
- Fire and Pollution No Objection Certificates (NOCs)
- Device Master File (DMF) detailing software design, development, validation, and maintenance (see our Device Master File guide)
- Plant Master File (PMF) outlining manufacturing infrastructure and processes (learn more here)
- Essential Principles Checklist demonstrating compliance with Indian safety and performance standards
- Risk Management File documenting hazard analysis, risk evaluation, and mitigation (Risk Management insights)
- Test Reports from CDSCO-approved labs
- Product Labels and Instructions for Use (IFU) compliant with CDSCO guidelines
- Quality Management System (QMS) documentation aligned with ISO 13485:2016
Import License Process (MD15) for Ventilator Software
For importers, the MD15 license issued by the central authority is mandatory. The process includes:
Document Compilation: Prepare requisite documents such as Manufacturing License from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE Certification, Device & Plant Master Files, and Wholesale License.
Application Submission: Submit your application on the CDSCO MD Online Portal using Form MD14.
Review and Query Resolution: CDSCO reviews the application and may request additional information.
Grant of MD15 License: License issuance allows importation and distribution in India.
Import License Documents Required
Key documents for ventilator software import include:
- Valid Manufacturing License from the exporting country
- Free Sale Certificate proving the device is marketed in the country of origin
- ISO 13485:2016 Certification
- CE Certificate for conformity to European standards
- Device Master File and Plant Master File
- Wholesale Drug License
- Company Constitution and incorporation proof
Timeline and Processing Duration
| License Type | Key Steps | Estimated Duration |
|---|---|---|
| Test License (MD13) | Sample testing authorization | 1.5 - 2 months |
| Manufacturing License (MD9) | Testing, audit, license approval | 4 - 5 months (including test license time) |
| Import License (MD15) | Documentation review, approval | 5 - 6 months |
Planning ahead is crucial due to the multi-step nature of approvals, especially for Class C devices like ventilator software.
Government Fees and Costs
| License Type | Application Fee | Per Product Fee |
|---|---|---|
| MD9 Manufacturing | INR 50,000 | INR 1,000 |
| MD15 Import | USD 3,000 (approx. INR 2,50,000) | USD 1,500 per product |
Note: Fees are subject to change; always verify on the CDSCO portal.
Common Challenges and Solutions
Complex Documentation: Preparing thorough Device and Plant Master Files can be daunting. Engage experts or use detailed templates to ensure compliance.
Test Lab Delays: Limited availability of approved testing laboratories may extend timelines. Early liaison with labs is advisable.
Audit Readiness: Nonconformities during CDSCO audits can delay licensing. Conduct internal audits to preempt issues.
Query Management: Proactive and prompt responses to CDSCO queries accelerate approvals.
Expert Consultation and Support
With over 25 years of experience and having assisted more than 500 companies, our regulatory consultancy specializes in navigating the CDSCO licensing maze for complex medical device software. Our services include document preparation, audit readiness, test lab coordination, and query resolution to streamline your approval process.
Getting Started with Your CDSCO License Application for Ventilator Software
Assess Your Device Classification: Confirm Class C designation using the Medical Device Classification tool.
Gather Preliminary Documents: Compile your company incorporation papers, manufacturing site details, and technical team credentials.
Initiate Test License Application: Submit Form MD13 via the CDSCO MD Online Portal to commence product testing.
Coordinate Product Testing: Engage with CDSCO-approved labs early to schedule testing.
Prepare Comprehensive Documentation: Develop your Device Master File, Plant Master File, and Risk Management File with precision.
Apply for MD9 License: Upon successful testing, submit Form MD7 for manufacturing license.
Plan for Audit: Ready your QMS and manufacturing processes for CDSCO inspection.
Monitor Application Status: Track and promptly respond to CDSCO queries through the online portal.
Starting your CDSCO licensing journey with structured planning and expert guidance can save months of delays and ensure your ventilator software reaches the Indian market efficiently and compliantly.
