CDSCO License for Software for vestibular function caloric stimulator
Medical Device Information
Intended Use
A software, which is designed to process data obtained from a vestibular function caloric stimulator. The resultant data are provided for diagnosis, etc.
Comprehensive CDSCO Licensing Guide for Software Vestibular Function Caloric Stimulator (Class B)
As seasoned regulatory consultants with over 25 years of experience and having supported 500+ medical device companies in India, we understand the unique challenges manufacturers face when entering the Indian market. Today, we provide an authoritative guide tailored specifically for obtaining the CDSCO license for the Software for Vestibular Function Caloric Stimulator, a Class B medical device under the CDSCO regulatory framework.
Introduction: Understanding Your Device and Regulatory Importance
The Software for Vestibular Function Caloric Stimulator is a specialized software tool designed to process data from vestibular function caloric stimulators, aiding clinicians in diagnosis and evaluation of vestibular disorders. Despite being software, it is regulated as a Class B medical device per CDSCO notification 29/Misc./03/2020-DC (198) dated 13.9.2021.
Why is obtaining a CDSCO license critical? The Central Drugs Standard Control Organization (CDSCO) mandates that all medical devices sold or manufactured in India comply with strict safety, efficacy, and quality standards. Without a valid license, marketing or importing this software in India is prohibited, risking penalties and business disruption.
CDSCO Regulatory Framework for Software Medical Devices
India's medical device regulation closely follows risk-based classification, where software that supports diagnosis often falls under Class B or higher, depending on its intended use and impact on patient safety. This software is classified as Class B, requiring a manufacturing license (MD5) from the State Licensing Authority.
The CDSCO framework involves:
- Submission of detailed technical dossiers
- Product testing in government-approved laboratories
- Audits by notified bodies
- Compliance with Essential Principles and Risk Management standards
For more on classification, see our in-depth Medical Device Classification guide.
Risk Classification and License Requirements for Class B Software
Class B devices are considered low to moderate risk. For this software, the key regulatory requirement is the MD5 license, which covers Class A and B devices. The MD5 license application process involves:
- Obtaining a Test License (Form MD13)
- Conducting mandatory product testing
- Preparing comprehensive documentation
- Undergoing audit by a notified body
- Resolving any queries raised
- Final license grant on Form MD5
Manufacturing License Process (MD5) for Software for Vestibular Function Caloric Stimulator
The MD5 license process typically takes 3-4 months from start to finish. Here’s a practical stepwise overview:
Apply for Test License (Form MD13): This preliminary license allows you to conduct product testing legally. Processing takes about 1.5-2 months.
Product Testing: You must have your software tested at government-approved labs listed on the official Testing Laboratories page. Testing focuses on software performance, safety, cybersecurity, and conformance to relevant standards.
Documentation Preparation: Compile all mandatory documents including Device Master File, Plant Master File, and Risk Management File.
Submit MD5 License Application (Form MD3): Use the CDSCO MD Online Portal to file your application.
Notified Body Audit: A notified body conducts a thorough audit of your manufacturing site and quality management system. Refer to the Notified Bodies List to choose appropriate auditors.
Queries Resolution: Address any clarifications or deficiencies raised by the authorities or auditors promptly.
License Grant: Upon satisfactory completion, the State Licensing Authority issues the MD5 license.
Manufacturing License Documents Required
For your software device, the following key documents are essential:
- Company Constitution and Incorporation Certificates
- Proof of Ownership or Lease of Manufacturing Premises
- Technical Staff Qualifications and Experience
- Fire and Pollution NOCs
- Device Master File (DMF): Detailed device description, design, and development data (Device Master File Guide)
- Plant Master File (PMF): Details on manufacturing facilities (Plant Master File Guide)
- Essential Principles Compliance Checklist
- Risk Management File: Demonstrate identification, analysis, and mitigation of risks (Risk Management Guide)
- Test Reports from Approved Labs
- Labels and Instructions for Use (IFU)
- Quality Management System (QMS) Documentation: ISO 13485 certification preferred
Import License Process (MD15) for Software Medical Devices
While the MD5 license covers manufacturing, importers require an MD15 import license issued by the Central Licensing Authority. For Class B devices, expect an application timeline of 5-6 months.
The MD15 process differs from MD5 in that no test license or product testing is mandated before application. Instead, the process emphasizes:
- Submission of manufacturing license from the country of origin
- Free Sale Certificate
- ISO 13485:2016 certification
- CE Certificate (if applicable)
- Device Master and Plant Master Files
- Wholesale License
Apply via the CDSCO MD Online Portal using Form MD14.
Import License Documents Required
- Valid Manufacturing License from the country of origin
- Free Sale Certificate
- ISO 13485:2016 and CE Certificate
- Detailed Device Master File and Plant Master File
- Wholesale License for distribution
- Company Constitution and Registration Proof
Timeline and Processing Duration for Class B Software Device
| Process Step | Duration |
|---|---|
| Test License (MD13) | 1.5 - 2 months |
| Product Testing | 1 - 1.5 months |
| Documentation Preparation | 2 - 3 weeks |
| MD5 License Application | Up to 1 month |
| Notified Body Audit | 2 - 3 weeks |
| Query Resolution and Grant | 2 - 3 weeks |
Total time: Approximately 3-4 months for MD5 license.
Government Fees and Costs Breakdown
- Test License Application Fee: Typically included within overall fees
- MD5 License Fee: Rs. 5,000 per application + Rs. 500 per product
- Testing Costs: Vary by laboratory and test scope, budget approx Rs. 1-2 lakhs
- Audit Fees: Fees paid directly to notified bodies, ranges Rs. 50,000 - Rs. 1,00,000
The investment is reasonable considering market access and regulatory compliance benefits.
Common Challenges and Solutions
- Delayed Testing Approvals: To mitigate delays, select laboratories early and submit samples promptly.
- Incomplete Documentation: Use checklists and expert guidance to ensure all documents are accurate and complete.
- Audit Observations: Prepare thoroughly by conducting internal audits and training staff.
- Query Resolution Delays: Assign dedicated personnel to respond quickly to CDSCO queries.
Our experience shows companies that proactively engage with notified bodies and maintain transparent communication enjoy smoother approvals.
Expert Consultation and Support
Navigating the CDSCO licensing maze can be complex. We offer tailored consulting services, from document preparation to audit assistance, helping you avoid costly mistakes. Our support includes:
- Strategic planning aligned with your device and business model
- Comprehensive document drafting and review
- Liaison with CDSCO and notified bodies
- Post-license compliance and vigilance support
Getting Started with Your CDSCO License Application
Evaluate your device classification: Confirm Class B status using the Medical Device Classification resource.
Prepare essential documents: Prioritize Device and Plant Master Files, QMS, and Risk Management documentation.
Apply for Test License (MD13): Initiate your test license application via the CDSCO MD Online Portal.
Select Testing Laboratory: Choose from the government-approved labs listed here.
Plan for Notified Body Audit: Review the list of Notified Bodies and schedule your audit.
Engage Expert Consultants: Consider partnering with seasoned professionals to streamline the process and reduce regulatory risks.
Following these practical steps can significantly reduce processing time and enhance your chances of a successful license grant.
For detailed guidance on MD5 license application, visit our MD5 License Guide.
Empower your business with compliant, timely CDSCO certification and confidently bring your Software for Vestibular Function Caloric Stimulator to the Indian healthcare market.
