CDSCO License for Software for pulmonary exercise stress monitoring system

Understanding CDSCO Licensing for Software Pulmonary Exercise Stress Monitoring Systems

Medical software that processes data from pulmonary exercise stress monitoring systems plays a pivotal role in respiratory healthcare, enabling precise evaluation of a patient’s pulmonary function during stress tests. Classified as a Class B device under the CDSCO framework, such software demands stringent regulatory compliance to ensure safety, efficacy, and quality before entering the Indian market. With over 25 years of regulatory consulting experience and 500+ successful license applications, we understand the nuances of navigating CDSCO licensing for software medical devices.

CDSCO Regulatory Framework for Software Medical Devices

The Central Drugs Standard Control Organization (CDSCO) governs medical device regulation in India. Software products designed for medical purposes, including pulmonary exercise stress monitoring systems, fall under the purview of medical devices as per the Notified Device List.

Specifically, this device is notified under 29/Misc./03/2020-DC (198) dated 13.09.2021, categorizing it as a Class B device. This classification mandates compliance with the Medical Device Rules, 2017, with a focus on safety and performance validation.

Risk Classification and License Requirements for Class B Software

Class B devices are considered low to moderate risk. For software like pulmonary exercise stress monitoring systems, the following applies:

License Type: MD5 Manufacturing License
Regulatory Authority: State Licensing Authority
Application Form: MD3 for Manufacturing License
Test License: Form MD13 (mandatory before MD5 application)

The entire process, including test license acquisition, product testing, documentation, audit, and license grant, typically spans 3 to 4 months.

Manufacturing License Process (MD5) for Class B Software

Step 1: Obtain Test License (Form MD13)

Before applying for the manufacturing license, manufacturers must secure a test license to validate the product’s compliance. This involves submitting an application via the CDSCO MD Online Portal and awaiting approval, which usually takes 1.5 to 2 months.

Step 2: Product Testing

The software must undergo thorough testing at CDSCO-approved laboratories to verify safety and performance parameters. Relevant Testing Laboratories can be selected from the official CDSCO list.

Step 3: Document Preparation

The comprehensive documentation package includes:

Company Constitution and incorporation certificates
Proof of ownership or lease of manufacturing premises
Details of technical staff including qualifications
Fire and pollution NOCs
Device Master File (DMF) detailing software design and development (Device Master File Guide)
Plant Master File (Plant Master File Guide)
Essential Principles Checklist demonstrating compliance with safety and performance standards
Risk Management File outlining hazard identification and mitigation strategies (Risk Management)
Test reports from approved labs
Product labels and Instructions for Use (IFU)
Quality Management System (QMS) documentation, preferably ISO 13485 compliant

Step 4: Application Submission

Apply for the MD5 license using Form MD3 on the CDSCO MD Online Portal, uploading all required documents.

Step 5: Notified Body Audit

A notified body conducts a detailed audit of the manufacturing site and quality systems. Find the list of notified bodies authorized for MD5 audits.

Step 6: Query Resolution and License Grant

Post audit, any queries raised by the department or notified body must be addressed promptly. Upon satisfactory compliance, the MD5 manufacturing license is granted on Form MD5.

Manufacturing License Documents Required

For software devices in Class B, ensure the following documents are meticulously prepared:

Company Constitution: Certificate of incorporation, partnership deed, or LLP agreement
Premises Ownership: Lease deed or ownership documents
Technical Staff Details: CVs and qualifications of key personnel
Fire and Pollution NOCs: From local authorities
Device Master File: Complete software architecture, validation, and verification protocols
Plant Master File: Description of manufacturing environment and facilities
Essential Principles Checklist: Compliance matrix
Risk Management File: Hazard analysis and mitigation plans
Test Reports: From CDSCO-approved labs
Product Labeling and IFU: Clear user instructions and safety warnings
Quality Management System: ISO 13485 certificates and SOPs

Import License Process (MD15) for Software Devices

If you intend to import this software into India, the MD15 Import License is mandatory.

Key Points:

Authority: Central Licensing Authority
Application Form: MD14
No Test License Needed: Unlike manufacturing, test license is not required
Documents: Manufacturing license from country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate (if applicable), Device and Plant Master Files, Wholesale license, Company Constitution
Timeline: Approximately 5 to 6 months
Government Fees: Based on risk class and number of products

Detailed guidance is available in our Import License Guide.

Timeline and Processing Duration

Process Stage	Duration
Test License (MD13)	1.5 – 2 months
Product Testing	3 – 4 weeks
Document Preparation	2 – 4 weeks
Notified Body Audit	3 – 4 weeks
Query Resolution	2 – 3 weeks
Total (MD5 License)	3 – 4 months

Timelines can vary based on the completeness of documentation and responsiveness during query resolution.

Government Fees and Costs

For Class B devices such as this software:

Test License (MD13): Approximately Rs 5,000
MD5 Manufacturing License: Rs 5,000 per application + Rs 500 per product
Testing Costs: Variable, depending on test scope and lab rates (typically Rs 1-2 lakhs for software validation)
Audit Costs: Charged by notified body (varies, typically Rs 50,000 to Rs 1,00,000)

Note that additional costs may include consultancy fees, document preparation, and QMS implementation.

Common Challenges and Solutions

Challenge 1: Delayed Test License Approval

Solution: Ensure all application fields are accurately completed, and supporting documents are uploaded in the prescribed formats. Early communication with State Authority expedites processing.

Challenge 2: Incomplete Documentation

Solution: Utilize comprehensive checklists and templates for Device and Plant Master Files. Our Device Master File guide helps avoid common pitfalls.

Challenge 3: Audit Non-Compliance

Solution: Conduct internal pre-audits and gap assessments before notified body visits. Maintain clear QMS records and staff training evidence.

Challenge 4: Query Resolution Delays

Solution: Assign dedicated regulatory personnel to respond promptly and precisely to CDSCO or notified body queries.

Expert Consultation and Support

Navigating India’s evolving medical device regulations can be complex, particularly for innovative software devices. Our team has guided over 500 companies through the CDSCO licensing maze, offering:

Tailored regulatory strategy and gap analysis
Document drafting and review
Pre-audit readiness assessments
Liaison with CDSCO and notified bodies

Partner with us to minimize delays and maximize your chances of timely license approval.

Getting Started with Your CDSCO License Application

Assess your device classification and confirm it as Class B according to CDSCO notifications.
Gather technical documentation including software validation reports and risk management files.
Apply for the Test License (MD13) via the CDSCO MD Online Portal.
Coordinate product testing at CDSCO-approved laboratories.
Prepare complete application packages including Device and Plant Master Files.
Select a notified body for your audit from the list of notified bodies.
Submit your MD5 License application (Form MD3) and prepare for audit.
Respond swiftly to queries to avoid processing delays.

By following these actionable steps and leveraging expert guidance, manufacturers and importers can successfully obtain CDSCO licensing for software pulmonary exercise stress monitoring systems, ensuring market access and compliance in India.

For detailed regulatory support and turnkey solutions, contact our consultancy to kickstart your application process today.