CDSCO License for Vascular clip

Comprehensive Guide to Obtaining CDSCO License for Vascular Clips (Class B Medical Device)

Introduction: Understanding Vascular Clips and Regulatory Importance

A vascular clip is an implanted extravascular device designed to occlude blood flow in small blood vessels other than intracranial vessels. Categorized under cardiovascular devices, vascular clips play a critical role in surgical interventions requiring precise vessel occlusion. Given their direct impact on patient safety, regulatory oversight by the Central Drugs Standard Control Organization (CDSCO) in India is stringent and mandatory for manufacturers and importers.

Navigating the CDSCO licensing process for vascular clips—classified as Class B medical devices—requires a thorough understanding of regulatory frameworks, documentation, testing, and audit procedures. With over 25 years of experience and having assisted 500+ companies, we offer you an expert, actionable roadmap to secure your CDSCO license efficiently.

CDSCO Regulatory Framework for Vascular Clips

The CDSCO governs medical devices under the Medical Device Rules (MDR) 2017, classifying devices into four risk classes: A, B, C, and D. Vascular clips fall under Class B, indicating moderate risk and necessitating compliance with specific regulatory protocols to ensure safety and performance.

As per Notification 29/Misc./03/2020-DC (159) dated 26.07.2021, vascular clips require a manufacturing license under the MD5 category, which is issued by the State Licensing Authority.

Risk Classification and License Requirements for Vascular Clips

• Risk Class: B (Moderate risk)
• License Type: MD5 Manufacturing License
• Authority: State Licensing Authority
• Application Form: MD3
• Process Duration: Approximately 3-4 months (including test license, product testing, audit, and query resolution)

Understanding your device’s classification is crucial for selecting the correct license type and aligning with the proper regulatory body.

Manufacturing License Process (MD5) for Vascular Clips

The MD5 license process is a multi-step journey involving test licensing, product testing, documentation, audit, and final license grant:

1. Obtain Test License (Form MD13): This initial step authorizes you to manufacture and test your vascular clips. The test license typically takes 1.5 to 2 months to be granted.

2. Product Testing: After obtaining the test license, your vascular clips must undergo testing at government-approved laboratories to verify compliance with applicable standards. Refer to the list of testing laboratories recognized by CDSCO.

3. Document Preparation: Compile the required documents such as Device Master File, Plant Master File, Risk Management File, Essential Principles Checklist, and Quality Management System (QMS) documentation.

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

5. Audit by Notified Body: A notified body conducts an on-site audit to verify your manufacturing processes and compliance. You can check the list of notified bodies for audit assignments.

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

7. Grant of License (Form MD5): Upon satisfactory compliance, the state authority grants your manufacturing license.

Manufacturing License Documents Required for Vascular Clips

Ensure you prepare and submit the following documents to avoid delays:

• Company Constitution/Registration Certificate
• Proof of Ownership or Lease Agreement for Manufacturing Premises
• Details and Qualification Certificates of Technical Staff
• Fire No Objection Certificate (NOC)
• Pollution Control Board NOC
• Device Master File (DMF) detailing the vascular clip specifications and manufacturing process (Device Master File Guide)
• Plant Master File describing manufacturing facilities and quality systems (Plant Master File Guide)
• Essential Principles Checklist confirming compliance with applicable standards
• Risk Management File demonstrating risk analysis and mitigation per ISO 14971 (Risk Management Guide)
• Product Test Reports from CDSCO-approved labs
• Product Labels and Instructions for Use (IFU)
• Quality Management System Documents (e.g., ISO 13485 certification)

Import License Process (MD15) for Vascular Clips

If you are an importer rather than a manufacturer, the MD15 import license is applicable. This license is granted by the Central Licensing Authority and generally takes 5-6 months.

Key steps include:

• Document preparation including manufacturing license of the foreign manufacturer, Free Sale Certificate, ISO 13485:2016, CE Certificate, and other relevant files
• Application submission on the CDSCO MD Online Portal
• Query resolution
• License grant on Form MD15

For detailed import license guidance, refer to our Import License Guide.

Import License Documents Required

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

Timeline and Processing Duration

Government Fees and Costs

• Application Fee: Rs. 5,000 per application
• Per Product Fee: Rs. 500 per product

Budget in advance for additional costs such as notified body audit fees, laboratory testing charges, and consultancy fees if you engage expert assistance.

Common Challenges and Solutions

• Delayed Test License Approval: Proactively prepare all documents and submit a complete application to avoid back-and-forth.
• Inadequate Technical Documentation: Invest time in compiling robust Device and Plant Master Files aligned with CDSCO guidelines.
• Audit Non-Compliance: Conduct pre-audit internal assessments and ensure your QMS is fully operational.
• Query Resolution Delays: Respond promptly and provide clear, evidence-backed explanations.

Expert Consultation and Support

With over 25 years of regulatory consulting experience, we have successfully guided 500+ companies through the CDSCO licensing process for Class B devices like vascular clips. Our services include:

• Comprehensive document preparation and review
• Coordination with notified bodies and testing labs
• Pre-audit readiness assessments
• Application filing and follow-up on CDSCO MD Online Portal

Getting Started with Your CDSCO License Application for Vascular Clips

1. Assess Your Device Classification: Confirm Class B status and understand applicable rules.
2. Prepare Documentation: Utilize expert guides such as our Device Master File Guide and Plant Master File Guide to prepare precise documentation.
3. Apply for Test License (MD13): Submit your initial test license application via the CDSCO MD Online Portal.
4. Coordinate Product Testing: Engage approved laboratories early to schedule testing and avoid bottlenecks.
5. Plan Audit Preparation: Identify your notified body and schedule the audit.

Starting early and leveraging expert guidance can dramatically reduce your time-to-market for vascular clips in India. Contact us to streamline your CDSCO licensing journey with confidence.