CDSCO License for Transluminal,  Coronary Angioplasty, Percutaneous  Catheter

Comprehensive CDSCO Licensing Guide for Transluminal Coronary Angioplasty Percutaneous Catheters (Class D)

As specialists with over 25 years of regulatory consulting experience, having supported 500+ medical device manufacturers and importers, we understand the critical importance of timely and compliant licensing for high-risk devices like the Transluminal Coronary Angioplasty Percutaneous Catheter. This guide delivers actionable insights into navigating India's CDSCO regulatory framework, specifically tailored for your Class D catheter device.

Introduction to Transluminal Coronary Angioplasty Percutaneous Catheters and Regulatory Importance

This catheter is designed for percutaneous insertion at the ostium of coronary arteries to facilitate angioplasty procedures. Given its invasive nature and direct impact on cardiovascular health, it is classified as a Class D medical device under CDSCO, denoting the highest risk category. The stringent regulatory requirements reflect the need to ensure patient safety, device efficacy, and compliance with quality standards.

CDSCO Regulatory Framework for Transluminal Catheters

In India, the Central Drugs Standard Control Organisation (CDSCO) oversees medical device regulation. For Class D devices, manufacturers must obtain the MD9 manufacturing license from the Central Licensing Authority, and importers require an MD15 import license. The regulatory framework is governed by the Medical Device Rules (MDR) 2017, supported by notifications such as 29/Misc/3/2017-DC (292), dated 06.06.2018, which specifically references catheters under high-risk categories.

Risk Classification and License Requirements for Your Device

Your Transluminal Coronary Angioplasty Percutaneous Catheter is a Class D device due to its critical use in coronary interventions. This classification mandates:

• MD9 Manufacturing License (Form MD7) issued by CDSCO Central Licensing Authority
• MD15 Import License (Form MD14) for importers

The process involves rigorous testing, technical documentation, and inspections to uphold safety and performance standards.

Manufacturing License Process (MD9) for Class D Catheters

Step 1: Obtain Test License (MD13)

Before applying for the MD9 license, manufacturers must apply for a Test License under Form MD13. This allows controlled manufacturing of trial batches for testing.

• Timeline: Approximately 1.5 to 2 months
• Purpose: To facilitate product testing at government-approved labs

Step 2: Product Testing

Testing must be conducted at CDSCO-recognized laboratories to verify compliance with Indian and international standards. You can review the official list of testing centers on the CDSCO Testing Laboratories page.

• Key Tests: Biocompatibility, sterility, functionality, and performance evaluations

Step 3: Document Preparation

Prepare and collate comprehensive documentation including the Device Master File (DMF), Plant Master File (PMF), Risk Management File, Essential Principles Checklist, and Quality Management System (QMS) records. Our detailed guides on creating a Device Master File and Plant Master File can help streamline this process.

Step 4: Application Submission (Form MD7)

Submit the application for the MD9 manufacturing license through the official CDSCO MD Online Portal. Include all required documents and test reports.

Step 5: CDSCO Inspection and Audit

CDSCO inspectors will conduct a thorough audit of your manufacturing facility and documentation. Address any queries promptly to avoid delays.

Step 6: License Grant (Form MD9)

Upon successful audit and document verification, CDSCO will grant the MD9 license, allowing full-scale manufacturing.

Manufacturing License Documents Required for MD9

• Company Constitution and Registration Proof
• Proof of Ownership or Lease of Manufacturing Premises
• Qualification and Experience Certificates of Technical Staff
• Fire Safety NOC and Pollution Control NOC
• Device Master File (DMF)
• Plant Master File (PMF)
• Essential Principles Checklist
• Risk Management File (per ISO 14971 guidelines)
• Test Reports from CDSCO-accredited labs
• Product Labels and Instructions for Use (IFU)
• Quality Management System Documentation (ISO 13485 compliant)

Import License Process (MD15) for Class D Catheters

Importers must apply for an MD15 license to legally import Class D catheters into India.

Step 1: Document Compilation

Gather necessary documents including:

• Valid Manufacturing License (MD9) from the country of origin
• Free Sale Certificate
• ISO 13485:2016 Certificate
• CE Certificate or equivalent
• Device Master File and Plant Master File
• Wholesale License
• Company Constitution

Step 2: Application Submission

Apply through the CDSCO MD Online Portal using Form MD14 for the import license.

Step 3: Queries and Clarifications

Respond promptly to any CDSCO queries to avoid processing delays.

Step 4: License Issuance

Once verified, CDSCO will issue the MD15 import license.

Timeline and Processing Duration

Government Fees and Costs

• MD9 Manufacturing License:
  • Application Fee: ₹50,000
  • Per Product Fee: ₹1,000
• Test License (MD13): Included in MD9 process
• MD15 Import License: Fees vary by class and product quantity
  • Class D: ₹3,000 per site + ₹1,500 per product

Note that these fees are subject to change; always verify current rates on the CDSCO portal.

Common Challenges and Practical Solutions

Challenge 1: Delays in Product Testing

• Solution: Engage early with CDSCO-recognized testing labs. Pre-book slots and confirm test requirements.

Challenge 2: Incomplete Documentation

• Solution: Use detailed checklists and expert reviews. Refer to our MD9 License Guide for document templates.

Challenge 3: Audit Non-Compliance

• Solution: Conduct pre-audit internal assessments and gap analyses. Train staff on regulatory compliance.

Challenge 4: Query Resolution Delays

• Solution: Maintain a regulatory point person to handle communications swiftly and efficiently.

Expert Consultation and Support

Navigating the CDSCO license process for high-risk devices demands expertise. Our seasoned consultants provide end-to-end support—from document preparation and test coordination to audit readiness and regulatory submissions. We have empowered over 500 companies to secure timely approvals, mitigating compliance risks.

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm your catheter's risk class and applicable license type.
2. Prepare Your Documentation: Initiate Device and Plant Master Files, Risk Management, and QMS documentation.
3. Apply for Test License (MD13): Submit through the CDSCO MD Online Portal.
4. Coordinate Product Testing: Engage with CDSCO-recognized labs early.
5. Compile and Submit MD9 Application: Upload all documents, test reports, and await audit scheduling.
6. Plan for Import Licensing: Once manufacturing license is secured, prepare import license documents.
7. Engage Expert Help: Consider partnering with regulatory consultants to streamline the process and avoid pitfalls.

By adhering to these steps and leveraging our insights, manufacturers and importers can efficiently access the Indian market with their Transluminal Coronary Angioplasty Percutaneous Catheter, ensuring patient safety and regulatory compliance.

For more detailed guidance, explore our comprehensive Import License Guide and get in touch with our experts today.