CDSCO License for Stationary pneumatic high-frequency ventilator respiration monitor
Medical Device Information
Intended Use
A mains electricity (AC-powered) device intended to continuously measure and display respiratory variables associated with the operation of a stationary pneumatic high-frequency ventilator. Measurements include proximal airway pressure, high-frequency percussive rates, mean airway pressures and inspiratory and expiratory times. It is typically equipped with audible and/or visual alarms that are triggered when respiratory parameters drop below or exceed pre-set limits, and connectors for attachment to the ventilator. It may be used for neonatal, paediatric, and adult patients.
Comprehensive Guide to CDSCO Licensing for Stationary Pneumatic High-Frequency Ventilator Respiration Monitor
The stationary pneumatic high-frequency ventilator respiration monitor is a critical Class C medical device intended for continuous respiratory variable monitoring in neonatal, pediatric, and adult patients. Given its vital role in patient care, regulatory compliance with the Central Drugs Standard Control Organisation (CDSCO) is mandatory before marketing the device in India. With over 25 years of expertise and having supported 500+ companies in securing CDSCO licenses, we provide you with a detailed roadmap tailored for this device.
CDSCO Regulatory Framework for Stationary Pneumatic High-Frequency Ventilator Respiration Monitors
Under the Medical Device Rules (MDR) 2017, this device falls under Class C due to its medium-to-high risk profile involving critical respiratory monitoring. The CDSCO is the central authority overseeing the licensing process for Class C devices, which involves stringent evaluation including product testing, documentation, and audits.
Risk Classification and License Requirements
- Risk Class: C (medium-high risk)
- License Type: MD9 Manufacturing License
- Authority: Central Licensing Authority, CDSCO
As a Class C device, manufacturers must obtain the MD9 license following a comprehensive application, including product testing and regulatory audits.
Manufacturing License Process (MD9)
The MD9 license process is multi-phased and typically spans 4-5 months:
- Test License Application (Form MD13): Before manufacturing, apply for a test license which takes approximately 1.5-2 months.
- Product Testing: Conduct mandatory testing of the ventilator respiration monitor at CDSCO-approved laboratories to validate compliance with essential performance and safety standards. Refer to the Testing Laboratories list.
- Document Preparation: Compile detailed technical documentation including Device Master File, Plant Master File, Risk Management File, and Essential Principles Checklist.
- License Application (Form MD7): Submit the MD9 manufacturing license application via the CDSCO MD Online Portal.
- Audit and Inspection: CDSCO inspectors conduct on-site audits to verify manufacturing practices, quality systems, and facility compliance.
- Queries Resolution: Respond promptly to any departmental or audit queries raised during the review.
- License Grant: Upon satisfactory evaluation, the MD9 license is issued.
Manufacturing License Documents Required
For this Class C device, comprehensive documentation is mandatory to demonstrate compliance:
- Company Constitution and Incorporation Certificates
- Proof of Ownership or Lease of Manufacturing Premises
- Qualification Details of Technical and Quality Personnel
- Fire and Pollution No Objection Certificates (NOCs)
- Device Master File (DMF): Detailed design and functional specifications. Learn more from our Device Master File guide.
- Plant Master File (PMF): Manufacturing process, equipment, and quality control systems. See our Plant Master File guide.
- Essential Principles Checklist confirming compliance with MDR 2017
- Risk Management File documenting hazard analysis and mitigations following ISO 14971 principles. For best practices, visit our Risk Management guide.
- Validated Test Reports from CDSCO-approved labs
- Product Labels, Instructions for Use (IFU), and Packaging Details
- Quality Management System (QMS) documentation, preferably ISO 13485:2016 certification
Import License Process (MD15)
Importers of this device must apply for the MD15 import license granted by the Central Licensing Authority. The process requires:
- Preparation of import-specific documentation including manufacturing license, free sale certificate, ISO 13485:2016, CE certificate, DMF and PMF.
- Application submission on the CDSCO MD Online Portal.
- Resolution of any queries raised by CDSCO.
The MD15 license process generally takes 5-6 months. Refer to our Import License guide for a detailed walkthrough.
Import License Documents Required
- Valid MD9 Manufacturing License from the Manufacturer
- Free Sale Certificate from the country of origin
- ISO 13485:2016 Quality Management System Certificate
- CE Certificate or equivalent approval
- Device Master File and Plant Master File
- Wholesale Drug License (if applicable)
- Company Constitution and Address Proof
Timeline and Processing Duration
| Process Stage | Estimated Duration |
|---|---|
| Test License (MD13) | 1.5 - 2 months |
| Product Testing | 3 - 4 weeks |
| License Application (MD9) | 1 month (including audit) |
| Queries Resolution | 2 - 3 weeks |
| Total Time for MD9 License | 4 - 5 months |
| Import License (MD15) | 5 - 6 months |
Government Fees and Costs
| License Type | Application Fee | Per Product Fee |
|---|---|---|
| MD9 (Class C) | Rs 50,000 | Rs 1,000 |
| MD15 Import | USD 3,000 per site | USD 1,500 per product |
Additional costs include testing fees at government-approved labs and audit fees charged by notified bodies or CDSCO inspectors.
Common Challenges and Solutions
Challenge: Delays in test license approval and product testing.
Solution: Initiate test license application and sample testing early. Coordinate closely with notified testing labs to ensure timely sample evaluation.
Challenge: Incomplete documentation causing audit queries and rejections.
Solution: Maintain a thorough checklist covering all required documents. Engage experienced regulatory consultants to prepare and review submissions.
Challenge: Non-compliance with QMS and manufacturing standards during audits.
Solution: Implement ISO 13485:2016 certified QMS and conduct internal audits to identify gaps prior to CDSCO inspection.
Expert Consultation and Support
Navigating the CDSCO licensing process for a complex Class C device like the stationary pneumatic high-frequency ventilator respiration monitor requires strategic planning and expert know-how. Our team, with 25+ years of regulatory experience, offers:
- End-to-end license application management
- Customized documentation preparation including DMF and PMF
- Liaison with CDSCO authorities and notified bodies
- Pre-audit quality system assessments
Our proven track record of successfully guiding 500+ clients ensures a smooth, compliant entry into the Indian market.
Getting Started with Your CDSCO License Application
- Assess Risk Classification: Confirm Class C status based on device specifications and intended use.
- Prepare Documentation: Assemble key files—Device Master File, Plant Master File, Risk Management File, and QMS certificates.
- Apply for Test License: Submit Form MD13 via the CDSCO MD Online Portal to initiate product testing.
- Coordinate Product Testing: Engage CDSCO-approved laboratories early to avoid delays.
- Compile Application: Post-testing, prepare MD9 license application (Form MD7) ensuring all audit and regulatory requirements are met.
- Schedule Audit: Select a notified body (visit list of notified bodies) for inspection or coordinate with CDSCO inspectors.
- Submit Application and Follow Up: File your application online and respond promptly to any departmental queries.
By following these structured steps and leveraging expert guidance, manufacturers and importers can effectively navigate the CDSCO licensing process for stationary pneumatic high-frequency ventilator respiration monitors and bring their life-saving technology to patients across India.
For detailed assistance, reach out to our regulatory consultancy to initiate your CDSCO licensing journey today.
