CDSCO License for Pulmonary function analysis system, paediatric

Comprehensive Guide to CDSCO Licensing for Pulmonary Function Analysis System (Paediatric)

Navigating the regulatory landscape for medical devices in India can be complex, especially for specialized equipment like the Pulmonary Function Analysis System designed for paediatric use. This computerized instrument, crafted to assess lung volumes and mechanical parameters in infants and young children, demands thorough understanding of CDSCO compliance, given its unique pediatric adaptations and diagnostic importance.

With over 25 years of experience and having assisted 500+ companies in securing CDSCO licenses, we provide a detailed roadmap tailored to manufacturers and importers of this Class B device under the Pediatrics and Neonatology category.

CDSCO Regulatory Framework for Paediatric Pulmonary Function Analysis Systems

The Central Drugs Standard Control Organisation (CDSCO) governs the import and manufacturing licensing for medical devices in India. This device falls under Class B risk classification, which requires adherence to the regulatory pathway managed primarily at the State Licensing Authority level.

The regulatory notification specific to this device is File No. 29/MiscJ03/2020-DC (150), dated 23.8.2021. This formalizes the device's classification and regulatory requirements, ensuring patient safety and performance standards.

Risk Classification and License Requirements

Class B devices are moderate-risk products requiring an MD5 manufacturing license. This involves submission of comprehensive technical documentation, product testing, and inspections by notified bodies. Importers need an MD15 license governed by the Central Licensing Authority.

For a Paediatric Pulmonary Function Analysis System (PFA System), the risk lies in ensuring accurate diagnostic capability in a vulnerable population, which CDSCO addresses through stringent evaluation protocols.

Manufacturing License Process (MD5)

The MD5 license for Class B devices is granted by State Authorities and involves multiple stages:

1. Test License Application (Form MD13): The initial step involves obtaining a test license to conduct product testing in government-approved labs.
2. Product Testing: Samples are sent to CDSCO-recognized laboratories for performance and safety evaluation.
3. Documentation Preparation: This includes device master files, plant master files, risk management files, and more.
4. License Application (Form MD3): After successful testing, the formal manufacturing license application is submitted.
5. Audit by Notified Body: An audit of manufacturing facilities and quality systems is conducted by a notified body listed here.
6. Query Resolution: Any queries raised by CDSCO or the notified body are addressed promptly.
7. License Grant (Form MD5): Upon satisfactory compliance, the manufacturing license is issued.

Manufacturing License Documents Required

For the Pulmonary Function Analysis System (Paediatric), the following documents are essential:

• Company constitution and proof of legal entity
• Ownership proof or lease agreement of the manufacturing premises
• Details and qualifications of technical staff
• Fire and Pollution No Objection Certificates (NOCs)
• Device Master File (DMF) detailing design, specifications, and performance data (our Device Master File guide explains preparation)
• Plant Master File (PMF) describing manufacturing processes (Plant Master File guide)
• Essential Principles Checklist confirming compliance with Indian regulations
• Risk Management File outlining hazard analysis and mitigation strategies (Risk Management insights)
• Test Reports from government-approved labs
• Labels and Instructions for Use (IFU) adapted for pediatric use
• Quality Management System (QMS) documentation, preferably ISO 13485:2016 certified

Import License Process (MD15)

For companies importing the Paediatric Pulmonary Function Analysis System into India, the MD15 import license process applies:

• No test license is required for import.
• Prepare a comprehensive documentation package including manufacturing license, Free Sale Certificate, ISO 13485:2016, CE certificate, device and plant master files.
• Submit application using Form MD14 on the CDSCO MD Online portal.
• Address any queries from CDSCO centrally.
• License grant on Form MD15 generally takes 5-6 months.

Import License Documents Required

Key documents include:

• Valid Manufacturing License from the country of origin
• Free Sale Certificate confirming market authorization abroad
• ISO 13485:2016 QMS certificate
• CE marking certificate (if applicable)
• Device Master File and Plant Master File
• Wholesale License (if applicable in India)
• Company Constitution and address proof

Timeline and Processing Duration

For import, the MD15 license takes approximately 5-6 months.

Government Fees and Costs

• MD5 License: Rs 5000 per application + Rs 500 per product
• Test License (MD13): No separate government fee but testing costs apply
• Testing Fees: Vary depending on the device complexity and laboratory

For import (MD15), fees depend on device class; for Class B devices, approx $2000 per site plus$1000 per product.

Common Challenges and Solutions

Challenge: Delays in testing due to limited slots at government-approved labs.

Solution: Early booking and engaging accredited third-party labs from the Testing Laboratories list can expedite this.

Challenge: Incomplete or inconsistent documentation, especially device and plant master files.

Solution: Follow detailed templates and checklists. Our guides on Device Master File and Plant Master File provide practical insights.

Challenge: Audit non-conformities related to QMS implementation.

Solution: Implement ISO 13485:2016 standards rigorously before audit. Conduct internal audits to prepare.

Expert Consultation and Support

With our extensive background in CDSCO regulatory affairs, we offer:

• End-to-end license application support
• Document preparation and review
• Audit readiness coaching
• Liaison with notified bodies and CDSCO officials

Our tailored approach ensures you avoid common pitfalls and accelerates market entry.

Getting Started with Your CDSCO License Application

1. Identify the Appropriate License: For manufacturing your Paediatric Pulmonary Function Analysis System (Class B), start with the MD5 license pathway.
2. Register on the CDSCO MD Online Portal: Submit initial applications and track progress through https://cdscomdonline.gov.in/.
3. Obtain Test License (MD13): Apply early to avoid delays.
4. Engage Accredited Labs: Coordinate product testing promptly.
5. Prepare Complete Documentation: Follow regulatory checklists meticulously.
6. Schedule Audit with Notified Body: Choose from the official Notified Bodies list.
7. Respond to Queries Quickly: Maintain open communication with CDSCO and notified bodies.

By following these practical steps and leveraging our expertise, manufacturers and importers of Paediatric Pulmonary Function Analysis Systems can successfully navigate the CDSCO licensing process and establish a compliant, competitive presence in the Indian medical device market.