CDSCO License for Therapeutic positive pressure breathing ventilator
Medical Device Information
Intended Use
A device used for therapeutic rehabilitation of patients with chronic respiratory diseases, and for the distribution of aerosolized pharmacological agents to the patient's airways and lungs.
Comprehensive Guide to CDSCO Licensing for Therapeutic Positive Pressure Breathing Ventilators (Class C)
As seasoned regulatory consultants with over 25 years of experience and a successful track record of assisting 500+ medical device companies, we understand the complexities involved in obtaining CDSCO licenses for advanced respiratory devices like Therapeutic Positive Pressure Breathing Ventilators. These devices play a vital role in therapeutic rehabilitation for chronic respiratory disease patients and facilitate the delivery of aerosolized pharmacological agents directly to the lungs. Navigating India's regulatory framework efficiently is crucial for timely market entry and compliance.
Understanding the CDSCO Regulatory Framework for Therapeutic Positive Pressure Breathing Ventilators
Therapeutic Positive Pressure Breathing Ventilators fall under the Respiratory category and are classified as Class C devices due to their medium to high risk nature. The licensing process is governed centrally by the CDSCO (Central Drugs Standard Control Organization) through the Ministry of Health and Family Welfare.
The governing notification for this device is File No. 29/Misc/03/2020-DC(197), dated 6.8.2021, which officially recognizes this device category for regulatory oversight in India.
Risk Classification and License Requirement for Class C Devices
Class C devices, such as therapeutic ventilators, require an MD9 Manufacturing License granted by the Central Licensing Authority. This license entails a more rigorous review, including product testing, documentation verification, and factory inspection/audit by CDSCO inspectors.
For importing such devices into India, an MD15 Import License is mandatory, also granted by the central authority.
Step-by-Step Manufacturing License Process (MD9) for Class C Devices
Test License Application (Form MD13)
- Before the manufacturing license, you must obtain a test license.
- Processing Time: Approximately 1.5 to 2 months.
Product Testing at CDSCO-Approved Laboratories
- Conduct mandatory product testing through notified labs listed on the CDSCO Testing Laboratories.
- Testing ensures compliance with standards and essential principles.
Document Preparation
- Assemble comprehensive documentation, including Device Master File (DMF), Plant Master File (PMF), Risk Management File, and Quality Management System (QMS) documents.
- Use expert resources such as our Device Master File guide and Plant Master File guide for compliance.
Application Submission (Form MD7)
- Submit the manufacturing license application through the CDSCO MD Online Portal.
Audit and Inspection by CDSCO
- CDSCO inspectors conduct a thorough audit of manufacturing facilities, QMS, and documentation.
- Non-compliance findings often relate to inadequate risk management or incomplete documentation, so thorough preparation is essential.
Resolution of Queries
- Promptly address any queries or deficiencies raised by the CDSCO.
Grant of Manufacturing License (Form MD9)
- Upon successful completion of all steps, the license is granted.
Manufacturing License Documents Required for Therapeutic Ventilators
- Company Constitution (Incorporation Certificate, MOA/AOA)
- Proof of Ownership or Lease Agreement of Manufacturing Premises
- Details and Qualification Proof of Technical Staff
- Fire NOC and Pollution Control NOC
- Device Master File (DMF) with detailed product specifications
- Plant Master File (PMF) detailing manufacturing processes
- Essential Principles Checklist affirming compliance to Indian standards
- Risk Management File demonstrating hazard analysis and mitigation per risk management best practices
- Test Reports from CDSCO-approved laboratories
- Product Labels and Instructions for Use (IFU)
- Quality Management System (QMS) Documentation (ISO 13485:2016 or equivalent)
Import License Process (MD15) for Therapeutic Positive Pressure Breathing Ventilators
Document Preparation
- Assemble required import documents including:
- Valid Manufacturing License (MD9) from the country of origin
- Free Sale Certificate
- ISO 13485:2016 Certification
- CE Certificate or Equivalent
- Device Master File and Plant Master File
- Wholesale License
- Company Constitution
- Assemble required import documents including:
Application Submission (Form MD14)
- Submit your application via the CDSCO MD Online Portal.
Query Resolution
- Address any department queries promptly.
Grant of Import License (Form MD15)
- Typical processing time is 5 to 6 months.
Timeline and Processing Duration Breakdown
| Process Stage | Duration |
|---|---|
| Test License (MD13) | 1.5 – 2 months |
| Product Testing | 3 – 4 weeks |
| Document Preparation | 3 – 4 weeks |
| Manufacturing License (MD9) | 2 – 3 months |
| Import License (MD15) | 5 – 6 months |
Total Time: Approximately 4 to 5 months for MD9 Manufacturing License and 5 to 6 months for MD15 Import License.
Government Fees and Costs
- MD9 Manufacturing License:
- Application Fee: ₹50,000
- Per Product Fee: ₹1,000
- MD13 Test License:
- Included in MD9 process; no additional fee apart from testing charges.
- MD15 Import License:
- Fees vary by device class and site; for Class C devices:
- ₹300,000 (approx. $3,000) per site
- ₹150,000 (approx. $1,500) per product
- Fees vary by device class and site; for Class C devices:
- Testing Laboratory Charges:
- Vary based on test scope; budget approximately ₹50,000 – ₹150,000 per test.
Common Challenges and Practical Solutions
Incomplete Documentation: Many applicants overlook detailed risk management files or essential principles checklists. We recommend early engagement with regulatory experts and use of checklists to avoid rejections.
Test Lab Delays: Testing at government-approved labs can take several weeks. Plan well in advance and consider accredited private labs where permissible.
Audit Non-Compliance: Common audit findings include inadequate QMS or insufficient technical staff. Conduct internal pre-audits to prepare thoroughly.
Delayed Query Resolution: Prompt and comprehensive responses to CDSCO queries speed up license grant. Assign a dedicated regulatory liaison for timely communication.
Expert Consultation and Support
Our expertise spans over two decades and includes assisting over 500 companies in successfully obtaining CDSCO licenses for complex Class C medical devices like ventilators. We offer:
- Tailored regulatory strategy and gap analysis
- Document preparation and review services
- Pre-audit inspections and staff training
- Liaison with CDSCO and notified bodies
Partnering with experienced consultants can significantly reduce approval times and ensure compliance.
Getting Started with Your CDSCO License Application for Therapeutic Ventilators
Assess Your Device Classification: Confirm your device is Class C under Indian regulations. Use our Medical Device Classification tool as a reference.
Initiate Product Testing: Contact CDSCO-approved laboratories to schedule your product tests early.
Compile Required Documentation: Gather your Device Master File, Plant Master File, Risk Management File, and QMS documents.
Apply for Test License (MD13): Submit your test license application on the CDSCO MD Online Portal.
Plan for Audit: Prepare your manufacturing site and documentation for CDSCO inspection.
Submit Manufacturing License Application (Form MD7): Once test license and testing are complete.
Engage with Experts: Consider partnering with regulatory consultants to guide you through the process smoothly.
By following these actionable steps and leveraging expert support, manufacturers and importers can confidently navigate the CDSCO licensing process for therapeutic positive pressure breathing ventilators and access the rapidly growing Indian healthcare market.
For detailed guidance tailored to your specific product and company profile, contact our regulatory consulting team today.
