Logo
Chat on WhatsApp

CDSCO License for Pleural manometer

Medical Device Information

Device Class
Class B

Intended Use

A noninvasive device intended to convert pressure into  electrical signals for the measurement of pressure within the pleural cavity.

Manufacturing License
MD5
Import License
MD15
CDSCO License for Pleural manometer

Introduction to Pleural Manometer and Its Regulatory Importance

The Pleural Manometer is a critical anesthesiology device designed to noninvasively convert pleural cavity pressure into electrical signals for precise measurement. Given its direct impact on patient safety during respiratory management, regulatory oversight by the Central Drugs Standard Control Organization (CDSCO) in India is stringent but navigable. Compliance ensures market access and patient safety, making CDSCO licensing an essential step for manufacturers and importers.

CDSCO Regulatory Framework for Pleural Manometer (Class B Medical Device)

As a Class B device under CDSCO’s risk classification, the Pleural Manometer falls under moderate risk. The regulatory framework mandates obtaining an MD5 manufacturing license (for domestic manufacturers) granted by the State Licensing Authority. This framework includes product testing, quality management system audits, and document verification to guarantee safety and performance.

Risk Classification and License Requirements

Based on Notification 29/Misc/03/2020-DC(177) dated 12.07.2021, the Pleural Manometer is classified as Class B.

  • License Type: MD5 Manufacturing License (Form MD3)
  • Licensing Authority: State Licensing Authority
  • Process Duration: Approximately 3-4 months including test license and audit
  • Fees: Rs. 5,000 per application + Rs. 500 per product

This licensing pathway requires initial acquisition of a Test License (Form MD13) to conduct mandatory testing.

Manufacturing License Process (MD5 License)

The MD5 license process for your Pleural Manometer involves the following key stages:

  1. Test License Application (Form MD13): Submit an application for a test license to manufacture the product sample for testing. This takes about 1.5 to 2 months.

  2. Product Testing: Conduct mandatory testing at CDSCO-approved laboratories to validate safety and performance. Refer to the list of testing laboratories.

  3. Document Preparation: Prepare comprehensive documentation including technical files, quality systems, and compliance evidence.

  4. License Application (Form MD3): Submit the MD5 license application through the CDSCO MD Online Portal.

  5. Audit by Notified Body: Undergo an audit by a CDSCO-approved notified body. You can check the list of notified bodies authorized to audit Class B devices.

  6. Query Resolution: Address any observations or queries raised by the licensing authority or notified body promptly.

  7. License Grant: Upon satisfactory review and audit clearance, the MD5 manufacturing license is granted on Form MD5.

Manufacturing License Documents Required

To streamline your application for the Pleural Manometer, ensure the following documents are meticulously prepared:

  • Company Constitution and Incorporation Certificates
  • Proof of Ownership or Lease Agreement of Manufacturing Premises
  • Details and Qualifications of Technical Staff
  • Fire Safety NOC and Pollution Control NOC
  • Device Master File (DMF) detailing design, specifications, and manufacturing process (Device Master File guide)
  • Plant Master File outlining manufacturing infrastructure and quality control processes (Plant Master File guide)
  • Essential Principles Checklist confirming compliance with Indian Medical Device Rules
  • Risk Management File documenting hazard analysis and mitigation strategies (Risk Management guide)
  • Test Reports from CDSCO-approved labs
  • Product Labels and Instructions For Use (IFU)
  • Quality Management System (QMS) documentation including ISO 13485 certification

Import License Process (MD15 License) for Pleural Manometer

For importers, an MD15 import license is required, granted by the Central Licensing Authority. The process, typically lasting 5-6 months, involves:

  1. Preparation of Import Documentation: Including Manufacturing License from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device Master File, Plant Master File, Wholesale License, and Company Constitution.

  2. Application Submission: Apply via the CDSCO MD Online Portal using Form MD14.

  3. Review and Query Resolution: The authority may raise queries that must be promptly addressed.

  4. License Grant: Final approval and issuance of MD15 license.

Note: No test license is required for import licensing.

Import License Documents Required

Key documents for MD15 license include:

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

Timeline and Processing Duration

Process StageDuration
Test License (MD13)1.5 - 2 months
Product Testing1 - 1.5 months
MD5 License Application1 month
Audit and Query Resolution0.5 - 1 month
Total for MD5 License3 - 4 months

For import license (MD15), the entire process typically takes around 5-6 months.

Government Fees and Costs

  • MD5 License: Rs. 5,000 per application + Rs. 500 per product
  • MD13 Test License: Included within MD5 application process
  • Import License (MD15): For Class B devices, Rs. 2,000 per site + Rs. 1,000 per product

Additional costs to consider include fees for notified body audits, product testing, and document preparation assistance.

Common Challenges and Solutions

  • Delays in Product Testing: To avoid delays, schedule tests well in advance with CDSCO-approved labs and ensure sample readiness. Refer to the Testing Laboratories list.

  • Incomplete Documentation: Meticulously follow checklists and ensure all required documents are signed, dated, and formatted per CDSCO guidelines.

  • Audit Non-Compliance: Engage with notified bodies early and conduct internal audits to pre-empt any non-conformities.

  • Query Resolution Delays: Assign a dedicated regulatory liaison to respond to CDSCO queries promptly to avoid prolonged approval timelines.

Expert Consultation and Support

With over 25 years of regulatory consultancy experience and having guided 500+ companies through CDSCO licensing, we offer tailored support for Pleural Manometer manufacturers and importers. Our services include:

  • Comprehensive gap analysis and documentation preparation
  • Coordination with notified bodies and testing labs
  • End-to-end application submission and follow-up
  • Post-license compliance and renewal assistance

Engage with us early to navigate the complexities of CDSCO licensing efficiently.

Getting Started with Your CDSCO License Application for Pleural Manometer

  1. Classify your device accurately as Class B using official CDSCO classification tools and confirm via the notification 29/Misc/03/2020-DC(177).

  2. Register on the CDSCO MD Online Portal to access application forms and track submissions.

  3. Initiate the Test License (MD13) application to start product testing timelines.

  4. Compile your Device Master File and Plant Master File in compliance with CDSCO guidelines.

  5. Schedule product testing at CDSCO-approved labs.

  6. Prepare for notified body audit by conducting internal quality system reviews.

  7. Submit your MD5 license application (Form MD3) post successful completion of testing and documentation.

  8. Maintain proactive communication with authorities to address queries swiftly.

By following these actionable steps, manufacturers and importers can position their Pleural Manometer successfully for timely market entry in India.

For detailed guidance, explore our in-depth MD5 License Guide and connect with our expert team for personalized assistance.

Get Expert Help

Free consultation for your medical device license

24/7 Support Available

Why Choose Us

500+ Licenses Obtained
100% Success Rate
15+ Years Experience
24/7 Support Available

About the Author

avatar
Tails Azimuth
@Twitter