CDSCO License for Monitoring Spirometer

Comprehensive Guide to CDSCO Licensing for Monitoring Spirometer (Class B Medical Device)

Introduction: Understanding Monitoring Spirometers and Regulatory Importance

Monitoring Spirometers are critical respiratory devices designed to continuously measure a patient’s tidal volume or minute volume, playing a vital role in evaluating ventilatory status. Given their direct impact on patient respiratory health, regulatory oversight by the Central Drugs Standard Control Organization (CDSCO) ensures these devices meet stringent safety and performance standards before entering the Indian market.

With over 25 years of experience guiding 500+ medical device manufacturers and importers through CDSCO licensing, we provide you the definitive roadmap to secure your license for a Class B Monitoring Spirometer efficiently.

CDSCO Regulatory Framework for Monitoring Spirometers

As per the CDSCO notification File No. 29/Misc/03/2020-DC(197) dated 6.8.2021, Monitoring Spirometers fall under the Respiratory category and are classified as Class B (low-moderate risk). This classification mandates compliance with the Medical Device Rules (MDR), 2017, and adherence to essential principles related to quality, safety, and performance.

License applications and regulatory procedures are managed through the CDSCO MD Online Portal, streamlining documentation and communication.

Risk Classification and License Requirements for Class B Devices

Class B devices like Monitoring Spirometers require an MD5 manufacturing license issued by the State Licensing Authority. The process includes obtaining a Test License (MD13), product testing through government-approved laboratories, and an audit by a notified body.

For more on classification, refer to our detailed Medical Device Classification guide.

Manufacturing License Process (MD5) for Monitoring Spirometers

1. Test License Application (Form MD13): Initiate with test license application to begin sample testing. This step typically takes 1.5 to 2 months.

2. Product Testing: Samples must be tested in CDSCO-approved labs to verify compliance. Access the list of approved Testing Laboratories.

3. Documentation Preparation: Prepare comprehensive technical files including Device Master File and Plant Master File.

4. Application for Manufacturing License (Form MD3): Submit the application for MD5 license on the online portal.

5. Audit by Notified Body: An audit verifies compliance with QMS and regulatory standards. Check the list of notified bodies.

6. Resolution of Queries: Respond promptly to any observations or queries raised by authorities.

7. Grant of MD5 License (Form MD5): After satisfactory completion, the license is granted.

For an in-depth walkthrough, our MD5 License Guide is an excellent resource.

Manufacturing License Documents Required

• Company Constitution and Incorporation Certificate
• Proof of Ownership or Lease of Manufacturing Premises
• Details and Qualifications of Technical Staff
• Fire NOC and Pollution Control NOC
• Device Master File (DMF) detailing device design and specifications (Device Master File guide)
• Plant Master File (PMF) describing manufacturing facility (Plant Master File guide)
• Essential Principles Checklist demonstrating compliance with MDR 2017
• Risk Management File tailored to the device (Risk Management insights)
• Product Test Reports from approved labs
• Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documentation, typically ISO 13485:2016 certification

Import License Process (MD15) for Monitoring Spirometers

Importers of Monitoring Spirometers into India must obtain an MD15 import license from the Central Licensing Authority. The process is as follows:

• Compile necessary documents including manufacturing license from country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device and Plant Master Files, wholesale license, and company constitution.
• Submit application using Form MD14 on the CDSCO MD Online Portal.
• Address any queries raised by the authorities.
• License grant typically takes 5-6 months.

Refer to our detailed Import License Guide for comprehensive insights.

Import License Documents Required

• Valid Manufacturing License of the foreign manufacturer
• Free Sale Certificate from the manufacturing country
• ISO 13485:2016 certification
• CE Certificate or equivalent
• Device Master File and Plant Master File
• Wholesale license for import and distribution
• Company Constitution and Registration Documents

Timeline and Processing Duration

Import license (MD15) typically takes 5-6 months due to central authority processing.

Government Fees and Costs

• MD5 License Application Fee: ₹5,000 per application
• Per Product Fee: ₹500 per product

For import licenses (MD15), fees vary by class and product count. For Class B devices, fees are roughly ₹2,000 per site and ₹1,000 per product.

Common Challenges and Solutions

Challenge 1: Delays in Test License Approval Solution: Submit a complete and error-free application for MD13 with all required documents to avoid back-and-forth.

Challenge 2: Incomplete or Poorly Prepared Device Master File Solution: Follow our Device Master File guide to ensure all technical details, design inputs, and risk assessments are thoroughly documented.

Challenge 3: Audit Non-compliance Solution: Prepare well in advance by conducting internal audits and ensuring your QMS aligns with ISO 13485:2016 standards.

Challenge 4: Query Resolution Delays Solution: Respond promptly with precise, evidence-backed replies to CDSCO queries.

Expert Consultation and Support

Navigating CDSCO’s regulatory landscape can be complex. Our team, having supported over 500 companies, offers tailored consultation, document preparation, audit readiness, and application submission services to streamline your licensing journey.

Getting Started with Your CDSCO License Application

• Step 1: Assess your device classification and confirm it as Class B Monitoring Spirometer.
• Step 2: Prepare your Device Master File and Plant Master File according to CDSCO requirements.
• Step 3: Apply for the Test License (Form MD13) via the CDSCO MD Online Portal.
• Step 4: Coordinate product testing at CDSCO-approved laboratories.
• Step 5: Assemble the full application for the MD5 Manufacturing License (Form MD3) including all technical and legal documents.
• Step 6: Arrange for a notified body audit and prepare for any follow-up queries.
• Step 7: Upon license grant, maintain compliance with post-market surveillance and renewals.

Starting early and leveraging expert guidance can significantly reduce your time-to-market and ensure uninterrupted regulatory compliance for your Monitoring Spirometer in India.

For personalized assistance, reach out to our regulatory experts who specialize in respiratory devices and CDSCO licensing.