CDSCO License for Atherectomy Coronary Catheter

Comprehensive Guide to CDSCO Licensing for Atherectomy Coronary Catheter (Class D Medical Device)

As seasoned regulatory consultants with over 25 years of expertise and having successfully guided 500+ medical device companies, we understand the complexities involved in obtaining CDSCO licenses for high-risk devices like the Atherectomy Coronary Catheter. This specialized catheter, classified as a Class D device due to its invasive nature and critical use in coronary atherectomy procedures, requires stringent regulatory compliance to ensure safety and efficacy before accessing the Indian market.

Understanding the Atherectomy Coronary Catheter and Its Regulatory Importance

The Atherectomy Coronary Catheter is a sophisticated medical device featuring a rotating cutter for endarterectomy and a debris collecting chamber, designed to remove plaques within coronary arteries. Given its direct interaction with the cardiovascular system, it is classified under Class D – the highest risk category. This classification mandates rigorous evaluation and licensing by the Central Drugs Standard Control Organization (CDSCO) to mitigate patient risks and comply with Indian medical device regulations.

CDSCO Regulatory Framework for Atherectomy Coronary Catheters

The CDSCO governs medical device regulation under the Medical Device Rules, 2017. For Class D devices such as this catheter, the regulatory framework involves centralized licensing through CDSCO’s Central Licensing Authority. The licensing process includes product testing, documentation review, and facility audits to uphold quality standards.

Risk Classification and License Requirements for Class D Catheters

Your Atherectomy Coronary Catheter falls under:

• Risk Class: D
• Category: Catheters
• Notification: 29/Misc/3/2017-DC (292), dated 06.06.2018

Class D devices require an MD9 manufacturing license (Form MD7) issued by CDSCO, and an MD15 import license (Form MD14) for importers. Both licenses demand comprehensive technical and quality documentation, product testing from government-approved labs, and strict adherence to Good Manufacturing Practices (GMP).

Manufacturing License Process (MD9) for Class D Devices

The manufacturing license process is intricate and involves the following key steps:

1. Test License Application (Form MD13): Initially, obtain a test license allowing product testing; this takes approximately 1.5 to 2 months.
2. Product Testing: Conduct mandatory product testing in government-approved laboratories. For your device, testing parameters will focus on biocompatibility, mechanical integrity, sterility, and performance.
3. Document Preparation: Compile required documents including Device Master File, Plant Master File, Risk Management File, Essential Principles Checklist, and QMS documentation.
4. License Application (Form MD7): Submit the manufacturing license application through the CDSCO MD Online Portal.
5. Audit by CDSCO Inspectors: Undergo a comprehensive audit of your manufacturing facility and documentation.
6. Query Resolution: Address any observations or queries raised by the CDSCO or the notified body.
7. License Grant (Form MD9): Upon satisfactory compliance, the MD9 license is granted.

For detailed guidance, refer to our MD9 License Guide.

Manufacturing License Documents Required

To streamline your application, ensure the following are meticulously prepared:

• Company Constitution and Registration Proof
• Proof of Ownership/Lease of Manufacturing Premises
• Technical Staff Qualifications and Experience
• Fire and Pollution No Objection Certificates (NOCs)
• Device Master File detailing design, materials, and specifications (Device Master File Guide)
• Plant Master File showcasing manufacturing processes and controls (Plant Master File Guide)
• Essential Principles Checklist confirming compliance with Indian regulations
• Risk Management File validating hazard analysis and mitigation (Risk Management)
• Product Test Reports from approved testing laboratories (Testing Laboratories)
• Product Labels and Instructions for Use (IFU)
• Quality Management System Documents (ISO 13485:2016 certification preferred)

Import License Process (MD15) for Atherectomy Coronary Catheter

For importers, the MD15 license application follows these steps:

1. Document Compilation: Prepare your manufacturing license, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate, Device and Plant Master Files, Wholesale License, and Company Constitution.
2. License Application (Form MD14): File your application via the CDSCO MD Online Portal.
3. Departmental Review: CDSCO reviews documentation and may raise queries.
4. Grant of Import License (Form MD15): Upon successful review, the import license will be issued.

For further details, consult our Import License Guide.

Import License Documents Required

• Valid Manufacturing License (MD9) from country of origin
• Free Sale Certificate from the country of manufacture
• ISO 13485:2016 Quality Management System Certificate
• CE Certificate or equivalent regulatory approval
• Device Master File and Plant Master File
• Wholesale Drug License (if applicable)
• Company Constitution and Address Proof

Timeline and Processing Duration

From start to finish, manufacturers can expect around 4 to 5 months for MD9 licensing, while importers should budget for 5 to 6 months to complete the MD15 import license process.

Government Fees and Costs

*Import fees are calculated in USD as per CDSCO guidelines: $3,000 per site and$1,500 per product for Class D devices.

Budgeting for testing fees, notified body audits, and consultancy support is also essential. Testing costs vary depending on the extent of biocompatibility and mechanical testing required.

Common Challenges and Solutions

1. Delays in Product Testing: Testing can often extend due to limited slots at government-approved labs. We advise early booking and parallel preparation of documentation.

2. Documentation Gaps: Incomplete or inconsistent Device Master Files or Plant Master Files often cause query escalations. Utilizing comprehensive templates and expert reviews can mitigate this.

3. Audit Non-Compliance: Manufacturing sites sometimes fail audits due to inadequate QMS implementation. Pre-audit mock assessments are invaluable.

4. Query Management: Prompt and precise responses to CDSCO queries shorten approval timelines. We recommend maintaining a dedicated regulatory liaison.

Expert Consultation and Support

With our extensive track record, we offer tailored solutions including document preparation, audit readiness, and liaison with CDSCO and notified bodies. We guide you through the entire lifecycle from test license acquisition to final license grant, ensuring regulatory compliance and market readiness.

Getting Started with Your CDSCO License Application for Atherectomy Coronary Catheter

To embark on your licensing journey:

1. Assess Your Device Classification: Confirm Class D and understand regulatory obligations via our Medical Device Classification resource.
2. Prepare Your Test License Application: Initiate your test license (Form MD13) submission through the CDSCO MD Online Portal.
3. Engage a Notified Body: Identify an appropriate notified body for audits and pre-assessment.
4. Plan Laboratory Testing: Schedule testing with CDSCO-approved laboratories early in the process.
5. Compile Documentation: Use expert templates for Device and Plant Master Files, Risk Management, and QMS documents.

Taking these concrete steps early will significantly smooth your path to gaining MD9 manufacturing and MD15 import licenses for your Atherectomy Coronary Catheter, enabling timely and compliant access to the Indian market.

For personalized assistance, connect with our expert team and leverage our 25+ years of experience to ensure your CDSCO licensing success.