CDSCO License for Vascular graft/occluders/Cardiac Patches
Medical Device Information
Intended Use
Intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access.
Comprehensive Guide to CDSCO Licensing for Vascular Grafts, Occluders, and Cardiac Patches (Class D Devices)
Navigating the regulatory landscape for high-risk medical devices like vascular grafts, occluders, and cardiac patches can be complex. These devices fall under Class D – Internal Prosthetic Replacements and are intended for critical vascular interventions excluding coronary or cerebral vasculature. As experienced regulatory consultants with over 25 years and 500+ successful CDSCO license approvals, we understand the nuances of manufacturing and importing such sophisticated devices in India.
CDSCO Regulatory Framework for Vascular Grafts and Cardiac Patches
The Central Drugs Standard Control Organization (CDSCO) regulates all medical devices in India under the Medical Device Rules, 2017. Devices classified as Class D represent the highest risk and require rigorous compliance with safety, efficacy, and quality standards before market authorization. The relevant notification for these devices is 29/Misc/3/2017-DC (292) dated 06.06.2018.
Risk Classification and License Requirements for Class D Devices
Class D devices like vascular grafts and cardiac patches mandate a MD9 manufacturing license issued by the Central Licensing Authority (CLA). This is due to their invasive nature and critical role in patient safety.
- License Type: MD9
- Application Form: MD7
- Authority: Central Licensing Authority
- Typical Timeline: 4–5 months (including test license, testing, audit, and query resolution)
- Fees: ₹50,000 per application + ₹1,000 per product
Manufacturing License Process (MD9) for Vascular Grafts and Cardiac Patches
Test License (Form MD13):
- Before applying for the MD9 license, manufacturers must obtain a test license for the device.
- Processing time: Approximately 1.5–2 months.
- This license permits sample testing from government-approved labs.
Product Testing:
- Samples must be tested at CDSCO-recognized laboratories to verify compliance with standards.
- Refer to the list of testing laboratories for approved centers.
Document Preparation:
- Compile a comprehensive dossier including technical documentation, quality management system (QMS) evidence, and risk management files.
Application Submission:
- Submit the MD9 application using Form MD7 via the CDSCO MD Online Portal.
Audit by CDSCO Inspectors:
- The manufacturing site undergoes a detailed inspection focusing on compliance with Good Manufacturing Practices (GMP), QMS, and regulatory requirements.
Query Resolution:
- Address any observations or queries raised by CDSCO or auditors promptly.
License Grant:
- Upon successful completion of all steps, the MD9 license (Form MD9) is issued.
For step-by-step guidance, our detailed MD9 License Guide offers deeper insights.
Manufacturing License Documents Required for MD9 Application
To ensure a smooth application process for vascular grafts and cardiac patches, the following documents must be meticulously prepared:
- Company Constitution and Incorporation Documents
- Proof of Ownership or Lease of Manufacturing Premises
- Technical Staff Qualification and Experience Details
- Fire and Pollution No Objection Certificates (NOCs)
- Device Master File (DMF): Detailed design, manufacturing processes, and specifications. Explore our Device Master File Guide for best practices.
- Plant Master File (PMF): Description of manufacturing facility, equipment, and controls. See our Plant Master File Guide for comprehensive instructions.
- Essential Principles Checklist: Demonstrating compliance with Indian regulations.
- Risk Management File: Following ISO 14971 principles tailored for Class D devices. Learn how to implement risk management.
- Test Reports: From government-approved laboratories.
- Labels and Instructions for Use (IFU): Must comply with regulatory language and content requirements.
- Quality Management System Documentation: ISO 13485:2016 certification and related SOPs.
Import License Process (MD15) for Class D Vascular Devices
If you plan to import vascular grafts or cardiac patches, an MD15 import license is mandatory:
- Application Form: MD14
- Authority: Central Licensing Authority
- Timeline: 5–6 months
- Fees:
- Class D: ₹3,000 per site + ₹1,500 per product
Key steps:
- Prepare required documentation including manufacturing license of the exporting company, Free Sale Certificate, ISO 13485:2016, CE Certificate (if applicable), and the device master and plant master files.
- Apply on the CDSCO MD Online Portal.
- Respond promptly to any queries.
- License issuance on Form MD15.
Our Import License Guide provides a detailed roadmap.
Timeline and Processing Duration
| License Type | Process Duration | Key Milestones |
|---|---|---|
| Test License (MD13) | 1.5–2 months | Sample testing approval |
| Manufacturing License (MD9) | 4–5 months | Audit and license issuance |
| Import License (MD15) | 5–6 months | Document review and license |
Plan for at least 5 months upfront for manufacturing licenses and 6 months for import licenses, considering possible query responses.
Government Fees and Costs Breakdown
| License Type | Application Fee | Fee per Product |
|---|---|---|
| MD9 (Class D) | ₹50,000 | ₹1,000 |
| MD15 (Import Class D) | ₹3,000 | ₹1,500 |
Additional costs include product testing fees at approved laboratories and audit fees (if applicable).
Common Challenges and Solutions
Challenge 1: Delays in Documentation Preparation
- Solution: Engage experts early to prepare DMF and PMF thoroughly, reducing back-and-forth.
Challenge 2: Lengthy Testing and Audit Processes
- Solution: Select accredited testing labs from the CDSCO-approved list and prepare audit checklists in advance.
Challenge 3: Query Resolution Delays
- Solution: Assign a dedicated regulatory liaison to respond swiftly and comprehensively to CDSCO queries.
Challenge 4: Compliance with QMS
- Solution: Implement ISO 13485:2016 and risk management per international standards early in development.
Expert Consultation and Support
With over two decades supporting 500+ medical device companies, we specialize in:
- Comprehensive dossier preparation tailored to vascular grafts and cardiac patches
- Coordinating sample testing and audit readiness
- Strategic query management
- Training on regulatory expectations and quality systems
Partnering with expert consultants significantly reduces approval timelines and enhances compliance confidence.
Getting Started with Your CDSCO License Application
Assess Device Classification: Confirm Class D status using our device classification resource.
Initiate Test License Application: Prepare documentation for Form MD13 and submit via the CDSCO MD Online Portal.
Plan for Testing: Identify appropriate government-approved labs early.
Develop Comprehensive Technical Files: Utilize our master file guides for DMF and PMF.
Schedule Pre-Audit Internal Review: Conduct mock audits to identify gaps.
Submit MD9 Application: Once test license and product testing are complete, apply for MD9.
Engage with CDSCO Proactively: Maintain open communication and respond promptly to queries.
Taking these actionable steps with experienced regulatory partners will streamline your pathway to market authorization. For personalized guidance and support, reach out to our regulatory team today.
Unlock your device’s potential in the Indian market with confidence and compliance. Learn more about our MD9 licensing services and start your application journey now.
