CDSCO License for Multivariate Vital Signs Index

Comprehensive Guide to Obtaining CDSCO License for Multivariate Vital Signs Index (Class B Software)

Entering the Indian medical device market with a specialized software device such as the Multivariate Vital Signs Index demands a thorough understanding of the CDSCO regulatory landscape. This device, intended for automated calculation of summary indices based on multiple vital sign inputs, is classified as a Class B medical device under the latest CDSCO notification (29/Misc./03/2020-DC (198) dated 13.9.2021). As experienced regulatory consultants with over 25 years and 500+ successful CDSCO licensing projects, we provide you with a detailed roadmap to navigate the licensing process efficiently.

CDSCO Regulatory Framework for Software-Based Medical Devices

The Central Drugs Standard Control Organisation (CDSCO) governs the import and manufacture of medical devices in India. Software devices, especially those involved in diagnostic or therapeutic support like the Multivariate Vital Signs Index, fall under stringent scrutiny due to their impact on clinical decisions.

Since your device operates by automated calculation of vital signs indices, it is regulated under Class B risk category, implying moderate risk and necessitating compliance with specific licensing and quality requirements as per the Medical Device Rules (MDR), 2017.

Risk Classification and License Requirements for the Multivariate Vital Signs Index

Under CDSCO's classification system, Class B devices require a Manufacturing License (MD5) granted by the State Licensing Authority. The import of such devices requires an Import License (MD15) from the Central Licensing Authority.

Key Points:

• Device Category: Software
• Risk Class: B
• License Type for Manufacturing: MD5 (Form MD3)
• License Type for Import: MD15 (Form MD14)

For detailed classification verification, manufacturers can refer to the Medical Device Classification guide.

Manufacturing License Process (MD5) for Class B Software Devices

The MD5 License process is multi-staged and typically spans 3 to 4 months. Here's a practical breakdown:

1. Test License Application (Form MD13): Before the MD5 license, you must obtain a test license to conduct product testing. This step takes approximately 1.5 to 2 months.

2. Product Testing: Conduct product testing at CDSCO-approved labs. Software devices like the Multivariate Vital Signs Index require rigorous functional and safety testing. Refer to the Testing Laboratories list for approved labs.

3. Document Preparation: Compile essential documents including Device Master File, Plant Master File, Risk Management File, and QMS records.

4. License Application Submission (Form MD3): Submit your MD5 application via the CDSCO MD Online Portal.

5. Audit by Notified Body: An audit is mandatory by a notified body listed on the Notified Bodies list.

6. Query Resolution: Address any observations or queries from CDSCO or the notified body promptly.

7. Grant of License (Form MD5): Upon successful audit and document verification, the manufacturing license is issued.

Manufacturing License Documents Required for Multivariate Vital Signs Index

For a Class B software device, prepare the following comprehensive documentation:

• Company Constitution Documents: Incorporation Certificate, Memorandum & Articles of Association
• Proof of Premises Ownership/Lease Agreement
• Technical Staff Qualifications and Experience Documents
• Fire and Pollution NOCs
• Device Master File (DMF): Detailed device description, software architecture, validation, and verification reports. Our Device Master File guide elaborates on this.
• Plant Master File (PMF): Manufacturing facility details as per our Plant Master File guide
• Essential Principles Checklist: Compliance with Indian Essential Principles for medical devices
• Risk Management File: Risk analysis, mitigation strategies, per Risk Management standards
• Test Reports: From approved laboratories confirming device safety and efficacy
• Labels and Instructions for Use (IFU): As per regulatory standards
• Quality Management System Documents: Typically ISO 13485:2016 certification and internal SOPs

Import License Process (MD15) for Class B Software Devices

If you plan to import the Multivariate Vital Signs Index, the process is centralized and slightly longer, taking about 5 to 6 months. The steps include:

1. Document Preparation: Collate import-specific documents such as Free Sale Certificate, ISO 13485:2016, CE Certificate, and existing Manufacturing License.

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

3. Query Resolution: Respond to any departmental queries diligently.

4. Grant of Import License (Form MD15): License issued upon satisfactory evaluation.

Import License Documents Required:

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

Timeline and Processing Duration

Government Fees and Costs

• MD5 License Fees: Rs. 5,000 per application + Rs. 500 per product
• MD15 Import License Fees:
  • Class B: Rs. 1,50,000 per site + Rs. 1000 per product

These fees are payable online through the CDSCO portal.

Common Challenges and Solutions

Challenge 1: Delays in Test License Approval

• Solution: Prepare complete and error-free test license applications. Engage experienced testing labs early.

Challenge 2: Incomplete or Insufficient Documentation

• Solution: Use checklists aligned with CDSCO requirements and consult guides like our Device and Plant Master File guides.

Challenge 3: Audit Non-compliance

• Solution: Conduct internal pre-audit assessments and ensure your QMS is fully operational.

Challenge 4: Query Resolution Delays

• Solution: Assign dedicated regulatory personnel for prompt responses.

Expert Consultation and Support

Navigating the CDSCO licensing maze can be daunting without expert support. Our team has successfully supported over 500 companies, ensuring smooth approvals for software-based Class B devices like the Multivariate Vital Signs Index. We offer end-to-end assistance:

• Gap analysis and regulatory strategy
• Documentation drafting and review
• Coordination with notified bodies and testing labs
• Application submission and follow-up

Getting Started with Your CDSCO License Application

To initiate your licensing journey:

1. Register your organization on the CDSCO MD Online Portal.
2. Apply for the Test License (Form MD13) promptly to kickstart the process.
3. Engage with an approved testing laboratory early to schedule product evaluation.
4. Begin preparing your Device and Plant Master Files alongside your QMS documentation.
5. Select a notified body from the official list to plan your audit.

We recommend contacting experienced regulatory consultants to tailor this process to your product specifics and timelines. With meticulous planning and expert guidance, your Multivariate Vital Signs Index can swiftly achieve CDSCO compliance and reach the Indian market confidently.

For personalized consultation or to learn more about our services, please reach out to our regulatory experts. Together, let's make your medical device journey in India a success story.