CDSCO License for Pneumoenceph alographic chair

Comprehensive Guide to CDSCO Licensing for Pneumoencephalographic Chair (Class B Medical Device)

As regulatory consultants with over 25 years of experience assisting more than 500 companies in securing CDSCO licenses, we understand the critical importance of compliance when introducing sophisticated medical devices like the Pneumoencephalographic Chair into the Indian market. This device, classified as Class B under the Interventional Radiology category, plays a vital role in supporting and positioning patients during pneumoencephalography, an advanced brain imaging procedure.

Navigating the CDSCO regulatory framework effectively ensures timely market entry and sustained compliance, reducing risks of delays or non-compliance penalties. In this detailed guide, we walk you through every step of the licensing process, from risk classification to license issuance, highlighting timelines, costs, and key documentation specific to Pneumoencephalographic Chairs.

CDSCO Regulatory Framework for Pneumoencephalographic Chair

The Central Drugs Standard Control Organization (CDSCO) governs medical device regulation in India. Devices are categorized by risk and intended use, guiding the licensing requirements. The Pneumoencephalographic Chair falls under:

• Category: Interventional Radiology
• Risk Class: B (Low to moderate risk)
• Regulatory Notification: 29/Misc./03/2020-DC (146), dated 26.07.2021

As a Class B device, the Pneumoencephalographic Chair requires a manufacturing license from the State Licensing Authority via the MD5 license pathway.

Risk Classification and License Requirements

India follows the risk-based classification system:

Since the Pneumoencephalographic Chair is Class B, manufacturers must apply for an MD5 license using Application Form MD3.

Manufacturing License Process (MD5) for Pneumoencephalographic Chair

The MD5 license process involves several critical stages:

1. Test License (Form MD13): Before applying for the MD5 license, a test license is mandatory to conduct product testing at CDSCO-approved laboratories.
2. Product Testing: Submit your Pneumoencephalographic Chair samples for testing to ensure compliance with Indian standards.
3. Document Preparation: Compile all required documents including Device Master File and Plant Master File.
4. Application Submission: File the MD5 license application (Form MD3) on the CDSCO MD Online Portal.
5. Audit by Notified Body: A notified body conducts a detailed audit of your manufacturing site and quality management system.
6. Query Resolution: Address any queries raised during audit or by the licensing authority.
7. License Grant: Upon satisfaction, the license is granted on Form MD5.

For detailed guidance, refer to our MD5 License Guide.

Manufacturing License Documents Required for Pneumoencephalographic Chair

Successful application requires a comprehensive dossier including:

• Company Constitution and Incorporation Certificates
• Proof of Ownership or Lease of Manufacturing Premises
• Details and Qualification Certificates of Technical Staff
• Fire NOC and Pollution Control NOC
• Device Master File (DMF): Detailed design, specifications, and manufacturing process (Device Master File Guide)
• Plant Master File (PMF): Description of manufacturing facilities and quality systems (Plant Master File Guide)
• Essential Principles Checklist confirming compliance with Indian Medical Device Rules
• Risk Management File documenting hazards and mitigation strategies (Risk Management)
• Test Reports from CDSCO-approved laboratories (Testing Laboratories)
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) Documentation, preferably ISO 13485:2016 certified

Import License Process (MD15) for Pneumoencephalographic Chair

For importers, the MD15 license is mandatory, obtained from the Central Licensing Authority. The process entails:

• Preparation of necessary documents including Manufacturing License from the country of origin, Free Sale Certificate, ISO 13485:2016 certificate, CE certificate, Device Master File, Plant Master File, and wholesale license.
• Application submission via Form MD14 on the CDSCO MD Online Portal
• Resolution of queries from CDSCO
• License grant on Form MD15

Note: Test license is not required for import license applications. The process typically takes 5-6 months.

For more details, explore our Import License Guide.

Import License Documents Required

• Valid Manufacturing License from the country of origin
• Free Sale Certificate
• ISO 13485:2016 certificate
• CE Certificate (if applicable)
• Device Master File
• Plant Master File
• Wholesale License
• Company Constitution and Incorporation Documents

Timeline and Processing Duration

For import license (MD15), the total timeline is approximately 5-6 months.

Government Fees and Costs

MD5 License (Class B Device)

• Application Fee: ₹5,000 per application
• Product Fee: ₹500 per product

Additional costs include:

• Testing laboratory fees (variable, depending on test complexity)
• Notified body audit charges (generally between ₹50,000 to ₹1,00,000)

MD15 Import License Fees

• Class B Device: $2,000 per site plus$1,000 per product

Practical Cost Management Tips

• Engage with notified bodies early to schedule audits
• Prepare documents meticulously to avoid repeated queries
• Choose CDSCO-approved labs with reasonable pricing and good turnaround

Common Challenges and Solutions

Challenge: Delays in test license approval and product testing

Solution: Initiate test license application promptly and partner with multiple CDSCO-approved testing laboratories to mitigate delays.

Challenge: Incomplete or inconsistent documentation

Solution: Use standardized templates for Device and Plant Master Files and conduct internal audits before submission.

Challenge: Audit non-conformities

Solution: Conduct pre-audit mock inspections with experienced regulatory consultants to ensure compliance.

Expert Consultation and Support

With over two decades of regulatory expertise, we provide end-to-end support—from initial classification, dossier preparation, test license facilitation, to audit coordination and query management. Our hands-on approach has enabled 500+ clients to successfully launch medical devices like the Pneumoencephalographic Chair in India.

Getting Started with Your CDSCO License Application

1. Determine your device classification: Confirm your Pneumoencephalographic Chair is Class B using the Medical Device Classification resource.
2. Register on the CDSCO MD Online Portal: Access the portal here and complete your company profile.
3. Prepare and submit the Test License (MD13) application: Secure this essential step to begin product testing.
4. Engage with CDSCO-approved testing laboratories: Plan for sample testing early to avoid bottlenecks.
5. Compile your documentation: Leverage our detailed guides on Device Master File and Plant Master File to ensure completeness.
6. Schedule and prepare for the notified body audit: Choose a notified body from the official list and conduct pre-audit readiness reviews.
7. Submit the MD5 license application: Use Form MD3 via the CDSCO portal and track your application.

Taking these practical steps with expert guidance will streamline your path to regulatory compliance and market success in India.

For personalized assistance tailored to your Pneumoencephalographic Chair manufacturing or import business, contact our regulatory consultancy team today.