CDSCO License for Apexcardiograph (vibrocardiograph)

Introduction to Apexcardiograph (Vibrocardiograph) and Regulatory Importance

The Apexcardiograph, also known as a vibrocardiograph, is a specialized cardiovascular medical device designed to amplify and condition signals from an apex cardiographic transducer, providing a visual display of heart motion. It also supplies necessary excitation energy to the transducer, aiding cardiologists in precise cardiac assessments. Given its critical role in cardiovascular diagnostics, regulatory compliance is essential to ensure safety, efficacy, and market access in India.

At our consultancy, with over 25 years of experience and having facilitated licensing for more than 500 companies, we understand the nuances of navigating the Central Drugs Standard Control Organisation (CDSCO) regulatory framework. This guide focuses on the licensing process for the Apexcardiograph, classified as a Class B medical device, offering practical insights tailored to this device type.

CDSCO Regulatory Framework for Apexcardiograph

The Apexcardiograph falls under the cardiovascular category and is classified as a Class B device by CDSCO, based on its moderate risk profile. The regulatory framework mandates obtaining a manufacturing license (MD5) from the State Licensing Authority before commercial manufacturing or marketing in India. For importers, an import license (MD15) from the Central Licensing Authority is required.

The device is notified under CDSCO Notification 29/Misc./03/2020-DC (159) dated 26.7.2021, emphasizing the need for adherence to the Medical Device Rules (MDR) 2017 and subsequent amendments.

For an overview of device classification, refer to our detailed Medical Device Classification guide.

Risk Classification and License Requirements for Apexcardiograph

• Risk Class: B (Moderate risk)
• License Type: MD5 Manufacturing License (Application Form MD3)
• Authority: State Licensing Authority
• Typical Processing Time: 3-4 months (including test license and audit)
• Fees: ₹5,000 per application + ₹500 per product

Class B devices like the Apexcardiograph require a structured process including obtaining a test license, product testing at CDSCO-approved labs, audit by notified bodies, and final license issuance.

Manufacturing License Process (MD5) for Apexcardiograph

1. Apply for Test License (Form MD13): This initial step enables you to manufacture the device for testing purposes. The test license typically takes 1.5 to 2 months to process.

2. Product Testing: Get the Apexcardiograph tested at CDSCO-approved laboratories. Refer to the list of testing laboratories for authorized centers.

3. Document Preparation: Prepare comprehensive documentation including Device Master File, Plant Master File, Risk Management File, Essential Principles Checklist, and Quality Management System (QMS) records.

4. Apply for Manufacturing License (Form MD3): Submit the application for the MD5 license on the CDSCO MD Online Portal.

5. Audit by Notified Body: A CDSCO-recognized notified body conducts a thorough audit of your manufacturing facility and quality systems. Check the list of notified bodies for suitable agencies.

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

7. License Grant: Upon satisfactory review and audit, the MD5 license is granted, allowing commercial manufacturing.

For a detailed MD5 licensing roadmap, explore our MD5 License Guide.

Manufacturing License Documents Required for Apexcardiograph

To ensure a smooth application process, prepare the following key documents:

• Company Constitution (Incorporation Certificate, Partnership Deed, etc.)
• Proof of ownership or lease agreement of manufacturing premises
• Qualification and experience documents of technical staff
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF) detailing design, specifications, and manufacturing processes. Our Device Master File guide provides comprehensive instructions.
• Plant Master File (PMF) outlining manufacturing infrastructure and quality systems, with practical tips in our Plant Master File Guide
• Essential Principles Checklist confirming compliance with safety and performance requirements
• Risk Management File demonstrating hazard analysis and mitigation according to ISO 14971. Learn more about implementing risk management.
• Test Reports from CDSCO-approved laboratories
• Device Labels and Instructions for Use (IFU)
• Quality Management System documentation (ISO 13485:2016 compliance evidence)

Import License Process (MD15) for Apexcardiograph

If you are an importer of the Apexcardiograph, you must obtain an MD15 import license from the Central Licensing Authority. The process includes:

1. Document Preparation: Collate documents such as the manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate, Device Master File, Plant Master File, and company constitution.

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

3. Query Resolution: Respond promptly to any queries raised.

4. License Issuance: Typically takes 5-6 months for completion.

Refer to our Import License Guide for step-by-step assistance.

Import License Documents Required

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

Timeline and Processing Duration

Government Fees and Costs

• MD5 Manufacturing License: ₹5,000 per application + ₹500 per product
• Test License (MD13): Included in the above process

For import licenses (MD15), fees vary by class and product quantity, with Class B devices like the Apexcardiograph incurring moderate charges.

Common Challenges and Solutions

• Incomplete Documentation: Ensure all documents, especially Device and Plant Master Files, are comprehensive and updated. Use our guides to avoid common pitfalls.

• Delays in Testing: Early coordination with CDSCO-approved labs can prevent bottlenecks. Plan testing schedules in advance.

• Audit Non-Compliance: Conduct internal audits before notified body visits to identify gaps.

• Query Management: Assign a dedicated team to address regulatory queries promptly to avoid processing delays.

Expert Consultation and Support

With decades of experience and over 500 successful CDSCO license approvals, we offer end-to-end consultancy services, including document preparation, mock audits, training, and liaison with regulatory authorities.

Our team stays updated with evolving regulations to ensure your Apexcardiograph licensing journey is seamless.

Getting Started with Your CDSCO License Application

1. Assess Your Device Risk Classification: Confirm Class B status per CDSCO notifications.

2. Prepare Required Documents: Begin compiling your Device Master File, Plant Master File, and QMS documentation.

3. Apply for Test License (MD13): Submit your test license application on the CDSCO MD Online Portal.

4. Plan for Product Testing: Schedule testing with an approved laboratory early.

5. Engage a Notified Body: Identify and contact a notified body from the official list to plan your audit.

6. Submit MD5 Application (Form MD3): Once testing and documentation are complete, file your manufacturing license application online.

7. Prepare for Audit and Queries: Conduct internal reviews and respond promptly to audit observations.

By following these actionable steps and leveraging expert guidance, manufacturers of Apexcardiograph devices can navigate the CDSCO licensing process effectively, ensuring timely market entry and compliance.

For personalized support tailored to your unique needs, contact our regulatory experts today.