CDSCO License for Peak flow meter

Introduction to Peak Flow Meter and Regulatory Importance

The Peak Flow Meter is a vital medical device used predominantly in anesthesiology and respiratory care. Designed to measure the maximum rate of expiratory gas flow (PEF/PEFR) and forced expiratory volume (FEV), it plays a crucial role in monitoring patients with chronic respiratory diseases both in clinical settings and at home. Given its direct impact on patient health, ensuring compliance with India's Central Drugs Standard Control Organization (CDSCO) regulations is essential for manufacturers and importers aiming to enter the Indian market.

Navigating the CDSCO licensing framework for a Class B medical device like the Peak Flow Meter requires precise knowledge of risk classification, documentation, and regulatory timelines. With over 25 years of experience and having supported 500+ companies in obtaining CDSCO licenses, we provide you with actionable insights to streamline your approval journey.

CDSCO Regulatory Framework for Peak Flow Meter (Class B Device)

The CDSCO regulates medical devices under the Medical Device Rules (MDR) 2017, with oversight based on risk classification. The Peak Flow Meter falls under Class B (low-moderate risk) as per the notification 29/Misc/03/2020-DC(177) dated 12.07.2021. This classification mandates adherence to specific licensing, testing, and quality management protocols.

Manufacturing licenses for Class B devices are granted by the State Licensing Authority under the MD5 license scheme (Form MD3 application), while import licenses require the MD15 license granted by the Central Licensing Authority.

Risk Classification and License Requirements for Peak Flow Meter

• Risk Class: B (Low-Moderate Risk)
• License Type for Manufacturing: MD5 License (Application Form MD3)
• License Type for Import: MD15 License (Application Form MD14)

The device's classification affects the licensing authority, timelines, fees, and technical requirements. Class B devices require a test license (MD13) before applying for the manufacturing license, including product testing by CDSCO-approved labs.

For an in-depth understanding of medical device classification, visit our Medical Device Classification guide.

Manufacturing License Process for Peak Flow Meter (MD5 License)

1. Test License (Form MD13): Initiate with obtaining a Test License from the State Licensing Authority, allowing sample testing.
2. Product Testing: Conduct mandatory testing at CDSCO-recognized laboratories to demonstrate compliance with Indian standards.
3. Document Preparation: Compile key documents such as Device Master File, Plant Master File, Risk Management File, and Quality Management System (QMS) evidence.
4. Application Submission (Form MD3): Submit your manufacturing license application via the CDSCO MD Online Portal.
5. Audit by Notified Body: A notified body will conduct an on-site audit to verify compliance. Refer to the List of Notified Bodies for audit agencies.
6. Query Resolution: Address any observations or queries raised by the licensing authority or notified body promptly.
7. Grant of License (Form MD5): Upon satisfactory review and audit, the manufacturing license is granted.

Timeline

• Test License (MD13): Approximately 1.5 to 2 months
• Product Testing: 2 to 3 weeks depending on lab capacity
• Application Processing and Audit: 1.5 to 2 months
• Total Duration: Approximately 3 to 4 months

Cost

• Government Fees: Rs 5,000 per application
• Product Fee: Rs 500 per product
• Additional costs include testing fees (varies by lab) and audit charges by notified bodies

For detailed guidance on MD5 manufacturing licenses, visit our MD5 License Guide.

Manufacturing License Documents Required for Peak Flow Meter

To ensure a smooth licensing process, prepare the following key documents:

• Company Constitution (Incorporation certificate, partnership deed, etc.)
• Proof of ownership or lease agreement of manufacturing premises
• Technical staff details (Qualification and experience certificates)
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF): Detailed device specifications, design, and manufacturing process. Our Device Master File guide can assist in preparation.
• Plant Master File (PMF): Factory layout, equipment details, and environmental controls. See our Plant Master File guide.
• Essential Principles Checklist demonstrating compliance with safety and performance requirements
• Risk Management File as per ISO 14971 standards
• Test Reports from CDSCO-approved labs
• Labeling and Instructions for Use (IFU) complying with CDSCO norms
• Quality Management System documentation (e.g., ISO 13485:2016 certification)

Import License Process for Peak Flow Meter (MD15 License)

Importers seeking to bring Peak Flow Meters into India must obtain the MD15 license from the Central Licensing Authority.

1. Document Preparation: Assemble all required documents including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certificate, CE marking (if applicable), and device-specific documentation.
2. Application Submission: Submit the application using Form MD14 on the CDSCO MD Online Portal.
3. Query Resolution: Respond to any departmental queries or requests for clarification.
4. Grant of License: Upon clearance, the MD15 license will be issued.

Timeline

• Entire process generally takes 5 to 6 months

Cost

• For Class B devices like Peak Flow Meter, fees are approximately $2,000 per site plus$1,000 per product

For an expert overview on import licensing, refer to our Import License Guide.

Import License Documents Required for Peak Flow Meter

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

Timeline and Processing Duration Summary

Government Fees and Costs

• MD5 License: Rs 5,000 per application + Rs 500 per product
• MD15 License: Approx. $2,000 per site +$1,000 per product for Class B
• Testing Fees: Varies by CDSCO-approved laboratory

Common Challenges and Solutions

• Delayed Testing Results: Choose CDSCO-recognized labs with proven turnaround times. Refer to the Testing Laboratories list for options.
• Incomplete Documentation: Use our comprehensive checklists for Device Master File and Plant Master File to avoid rejections.
• Audit Non-Compliance: Prepare thoroughly by conducting internal audits and addressing gaps beforehand.
• Query Management: Respond to CDSCO queries with clarity and supporting evidence to expedite approvals.

Expert Consultation and Support

With over 25 years in the regulatory consulting space and a track record of 500+ successful CDSCO licenses, we provide end-to-end support—from documentation to audit readiness and application submission. Our tailored services ensure compliance and faster market entry for your Peak Flow Meter.

Getting Started with Your CDSCO License Application

1. Assess Your Product Classification: Confirm your device is Class B as per CDSCO guidelines.
2. Engage a CDSCO-Approved Testing Laboratory: Submit samples early to avoid delays.
3. Prepare Detailed Device and Plant Master Files: Use our guides for accurate documentation.
4. Apply for the Test License (MD13) via the CDSCO MD Online Portal: This is your first official step.
5. Plan for Notified Body Audit: Schedule and prepare for the audit after product testing.
6. Submit Manufacturing License Application (Form MD3): Post successful audit and documentation.

Starting early and following a structured approach minimizes risks and accelerates your licensing journey. Contact us to leverage our expertise and ensure your Peak Flow Meter meets all CDSCO regulatory requirements seamlessly.