CDSCO License for Carotid Filter System

Introduction to Carotid Filter System and Regulatory Importance

The Carotid Filter System is a critical medical device used during angioplasty and stenting procedures in carotid arteries. Designed as a catheter-based device, it helps capture embolic debris to minimize stroke risk during interventions. Given its direct impact on patient safety and complex usage, the device falls under Class C risk classification in India, necessitating stringent regulatory compliance.

For manufacturers and importers aiming to enter the Indian market, understanding the CDSCO (Central Drugs Standard Control Organization) licensing framework is essential. Obtaining the appropriate CDSCO license not only ensures legal market access but also affirms the device’s safety and efficacy, building trust with healthcare providers and end users.

CDSCO Regulatory Framework for Carotid Filter Systems

As per CDSCO Notification 29/Misc/3/2017-DC (292) dated 06.06.2018, Carotid Filter Systems are categorized under Class C medical devices within the catheters category. This classification mandates a centralized licensing process involving the Central Licensing Authority of CDSCO.

The regulatory pathway includes mandatory product testing, comprehensive documentation, and facility audits to verify compliance with Indian regulatory standards and international best practices.

Risk Classification and License Requirements

• Device: Carotid Filter System
• Risk Class: Class C
• Category: Catheters
• License Type Required: MD9 Manufacturing License (Form MD7) for local manufacturers or MD15 Import License (Form MD14) for importers

Class C devices pose moderate to high risk, requiring a thorough evaluation by CDSCO, including mandatory testing and inspections. This contrasts with lower-risk Class A and B devices, which follow the MD5 licensing route.

For manufacturers of Carotid Filter Systems, the MD9 license is compulsory, issued by the Central Licensing Authority after successful completion of all regulatory requirements.

Manufacturing License Process (MD9)

The MD9 licensing process for Class C devices like Carotid Filter Systems involves several defined stages:

1. Test License Application (Form MD13): Initiate with a test license to manufacture and test the device, valid for 1.5 to 2 months.

2. Product Testing: Conduct mandatory tests at CDSCO-approved laboratories. The list of approved testing laboratories can be accessed for selecting an appropriate facility.

3. Documentation Preparation: Assemble comprehensive documentation including Device Master File (DMF), Plant Master File (PMF), Risk Management File, Essential Principles Checklist, Quality Management System (QMS) documents, and product labels.

4. License Application Submission: Submit Form MD7 for MD9 license through the CDSCO MD Online Portal.

5. CDSCO Inspection Audit: The CDSCO Inspector conducts a detailed audit of manufacturing premises, QMS implementation, and compliance with regulatory standards.

6. Queries and Clarifications: Address any observations or queries raised by CDSCO inspectors promptly.

7. Grant of MD9 License: Upon satisfactory compliance, the license is issued, allowing commercial manufacturing and sale within India.

For a detailed guide on MD9 licensing, refer to our comprehensive MD9 License Guide.

Manufacturing License Documents Required

The documentation package for Carotid Filter System MD9 licensing is extensive and includes:

• Certificate of Incorporation and Company Constitution
• Proof of ownership or lease of manufacturing premises
• Qualification and details of technical staff
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF) detailing design, specifications, and manufacturing process (Device Master File Guide)
• Plant Master File (PMF) describing infrastructure and quality management (Plant Master File Guide)
• Essential Principles Checklist demonstrating compliance with safety and performance standards
• Risk Management File aligned with ISO 14971 principles (Risk Management)
• Test Reports from CDSCO-approved labs
• Product labels, packaging details, and Instructions for Use (IFU)
• Quality Management System documentation, typically ISO 13485:2016 certification and internal SOPs

Ensuring completeness and accuracy of these documents significantly expedites the approval process.

Import License Process (MD15)

For importers of Carotid Filter Systems, obtaining the MD15 Import License is mandatory before marketing the device in India. This process is managed centrally by CDSCO and typically takes 5-6 months.

Key steps include:

• Document Preparation: Compile import-specific documents such as Free Sale Certificate from the country of origin, ISO 13485:2016 certification, CE marking certificates (if applicable), along with DMF and PMF.

• License Application: Submit Form MD14 for Import License through the CDSCO MD Online Portal.

• Query Resolution: Promptly respond to any departmental queries.

• License Issuance: CDSCO grants the MD15 license enabling legal import and sale.

For further details, our Import License Guide provides practical insights.

Import License Documents Required

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

The thoroughness of documentation directly impacts approval timelines.

Timeline and Processing Duration

Planning your project timeline around these durations is vital to avoid market entry delays.

Government Fees and Costs

• MD9 License:

  • Application Fee: Rs. 50,000
  • Product Fee: Rs. 1,000 per product variant

• MD15 Import License:

  • Class C Device Fees: $3,000 per site +$1,500 per product

Additional costs include product testing fees charged by approved laboratories and expenses for audits by CDSCO.

Common Challenges and Solutions

• Delay in Test Reports: Coordinate early with CDSCO-approved labs to schedule testing promptly.
• Incomplete Documentation: Use checklists and expert consultation to ensure no document gaps.
• Audit Non-Compliance: Conduct internal pre-audits to identify and rectify compliance issues.
• Query Backlogs: Assign dedicated personnel for prompt responses to CDSCO queries.

Proactive management of these pain points can streamline your licensing journey.

Expert Consultation and Support

With over 25 years of experience assisting 500+ companies in successfully obtaining CDSCO licenses, we provide tailored consultancy services:

• Gap analysis of your current documentation and processes
• Preparation of Device and Plant Master Files
• Coordination with testing laboratories and notified bodies
• Training and mock audits for your technical and quality teams
• Application filing and liaison with CDSCO officials

Our expert guidance ensures compliance and expedites approvals.

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm your Carotid Filter System falls under Class C as per the Medical Device Classification.
2. Plan Your License Path: Decide whether you require an MD9 Manufacturing License or MD15 Import License.
3. Gather Documentation: Begin compiling the essential files with accuracy and completeness.
4. Schedule Product Testing: Contact CDSCO-approved labs early to avoid delays.
5. Register on CDSCO MD Online Portal: Submit your application through the official CDSCO MD Online Portal to initiate the process.
6. Engage Expert Support: Consider partnering with a seasoned regulatory consultant to navigate complex requirements efficiently.

By following these practical steps, manufacturers and importers can confidently enter the Indian market with their Carotid Filter Systems, ensuring compliance and patient safety.

For further assistance and personalized consultancy, contact us to leverage our extensive expertise in CDSCO licensing for Class C medical devices.