CDSCO License for Whole-body plethysmograph

Comprehensive Guide to CDSCO Licensing for Whole-body Plethysmograph (Class B Respiratory Device)

As a trusted regulatory consultancy with over 25 years of experience and having assisted more than 500 companies in navigating the complexities of Indian medical device regulations, we understand the critical importance of securing the appropriate CDSCO license for your product. In this guide, we focus on the Whole-body plethysmograph—a Class B respiratory device used to measure airway resistance and thoracic gas volume for pulmonary function assessment—and provide detailed, actionable insights to help manufacturers and importers efficiently obtain the required CDSCO license.

Understanding the Whole-body Plethysmograph and Its Regulatory Significance

A Whole-body plethysmograph is a sophisticated graphic recorder essential in pulmonary diagnostics, particularly for assessing lung volumes and airway resistance. Given its direct impact on patient health outcomes, regulatory authorities classify this device as Class B under Indian medical device rules, mandating strict compliance with safety, efficacy, and quality standards.

The device falls within the respiratory category and is notified under File No. 29/Misc/03/2020-DC(197) as of 6.8.2021, confirming its regulatory recognition and requirement for licensing before marketing in India.

CDSCO Regulatory Framework for Whole-body Plethysmograph

The Central Drugs Standard Control Organization (CDSCO) governs the regulation of medical devices in India. For Class B devices like the Whole-body plethysmograph, the licensing process is managed by the State Licensing Authority through the MD5 license route. This involves a combination of product testing, documentation, audit, and compliance verification to ensure the device meets Indian regulatory standards.

Risk Classification and License Requirements

Medical devices in India are classified into four risk categories: A, B, C, and D. The Whole-body plethysmograph is Class B, representing low to moderate risk. Consequently, manufacturers must apply for an MD5 license (using Application Form MD3) issued by the State Licensing Authority. The process requires a prior test license (MD13) and product testing from government-approved laboratories.

For detailed classification, manufacturers can refer to the Medical Device Classification guide.

Manufacturing License Process (MD5) for Whole-body Plethysmograph

1. Test License Application (Form MD13): Initiate the process by applying for a test license, allowing product testing. This step typically takes 1.5 to 2 months.

2. Product Testing: Submit the device samples to CDSCO-recognized laboratories for performance, safety, and quality testing. A list of approved Testing Laboratories can be accessed for this purpose.

3. Documentation Preparation: Prepare comprehensive documents including Device Master File, Plant Master File, Essential Principles Checklist, and Risk Management File.

4. License Application (Form MD3): Submit the manufacturing license application through the CDSCO MD Online Portal.

5. Audit by Notified Body: A notified body conducts an on-site audit of your manufacturing facility. You can identify authorized auditors from the official list of notified bodies.

6. Query Resolution: Address any queries raised during the audit or application review process.

7. Grant of MD5 License: Upon satisfying all requirements, the State Licensing Authority issues the MD5 license.

Manufacturing License Documents Required

For a Whole-body plethysmograph manufacturing license, the following documents are essential:

• Company Constitution or Incorporation Certificate
• Proof of Ownership or Lease of Manufacturing Premises
• Technical Staff Qualifications and Experience
• Fire No Objection Certificate (NOC)
• Pollution Control Board NOC
• Device Master File (DMF) detailing design and specifications (Device Master File Guide)
• Plant Master File (PMF) describing manufacturing infrastructure (Plant Master File Guide)
• Essential Principles Checklist confirming compliance with Indian standards
• Risk Management File highlighting hazard analysis and mitigation (Risk Management Guide)
• Product Test Reports from CDSCO-approved labs
• Product Labels and Instructions for Use (IFU)
• Quality Management System Documents (e.g., ISO 13485:2016 certification)

Import License Process for Whole-body Plethysmograph (MD15)

If you are importing the Whole-body plethysmograph into India, an MD15 import license issued by the Central Licensing Authority is mandatory. The process differs as no test license is required, but comprehensive documentation and compliance with import regulations are critical.

Steps include:

• Preparing required documents including Manufacturing License, Free Sale Certificate, ISO 13485:2016, CE Certificate, and other technical files.
• Applying on the CDSCO MD Online Portal using Form MD14.
• Resolving any queries raised during the application review.
• Receiving the import license (Form MD15), typically within 5-6 months.

Import License Documents Required

• Valid Manufacturing License from 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 documents

Timeline and Processing Duration

Government Fees and Costs

For a Class B device like the Whole-body plethysmograph, the fee structure is as follows:

• Application Fee: INR 5,000
• Per Product Fee: INR 500

Note: Additional costs include product testing charges at government-approved laboratories and audit expenses charged by notified bodies.

Common Challenges and Solutions

Challenge: Delays in product testing due to sample preparation or lab backlogs.

Solution: Initiate sample readiness early and select testing labs based on their turnaround times. Maintain constant communication with laboratories.

Challenge: Incomplete or non-compliant documentation leading to repeated queries.

Solution: Leverage expert consultancy to prepare your Device Master File, Risk Management File, and QMS documents meticulously.

Challenge: Scheduling audits with notified bodies.

Solution: Identify and book audits in advance through the Notified Bodies List and remain flexible with dates.

Expert Consultation and Support

Our seasoned regulatory experts provide end-to-end support tailored to Class B respiratory devices such as the Whole-body plethysmograph. From initial classification and test license acquisition to audit facilitation and final licensing, our consultancy ensures a smooth, compliant, and timely approval process.

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm the Class B status of your Whole-body plethysmograph.

2. Engage with Testing Laboratories: Contact CDSCO-approved labs early to schedule product testing.

3. Gather and Prepare Documentation: Utilize our comprehensive guides for Device and Plant Master Files to streamline document preparation.

4. Apply for Test License (MD13): Submit your application via the CDSCO MD Online Portal.

5. Plan for Audit: Coordinate with notified bodies for audit scheduling post-test license approval.

6. Submit Manufacturing License (MD3): After successful testing and documentation readiness, apply for the MD5 license.

7. Resolve Queries Promptly: Assign dedicated personnel to address regulatory or audit queries.

By following these focused steps, your manufacturing or importing venture for the Whole-body plethysmograph will align with Indian regulatory expectations, facilitating market entry and sustained compliance.

For personalized assistance and to accelerate your CDSCO licensing journey, reach out to our expert team today.