CDSCO License for Endoscopic Ligation Devices

Comprehensive Guide to CDSCO Licensing for Endoscopic Ligation Devices (Class B Catheters)

Endoscopic ligation devices are specialized catheters designed for the proximal and distal ligation of vessels during endoscopic vessel harvesting procedures. These devices play a critical role in minimally invasive surgeries, ensuring vessel integrity and reducing patient recovery time. As medical device regulations tighten globally, navigating the Indian regulatory landscape for such devices requires precise understanding and compliance with the Central Drugs Standard Control Organization (CDSCO) framework.

With over 25 years of experience and having supported 500+ companies in successfully obtaining CDSCO licenses, we provide you with an expert, step-by-step guide tailored specifically for Class B medical devices like endoscopic ligation devices.

CDSCO Regulatory Framework for Endoscopic Ligation Devices

In India, medical devices are regulated under the Medical Device Rules (MDR) 2017, enforced by CDSCO. Endoscopic ligation devices fall under the category of "Catheters," which are notified medical devices under the CDSCO notification number 29/Misc/3/2017-DC (292) dated 06.06.2018.

The regulatory framework mandates obtaining a manufacturing license if you plan to produce these devices domestically or an import license for bringing them into the Indian market. The regulatory path depends primarily on the device’s risk classification.

Check medical device classification details to confirm your device class.

Risk Classification and License Requirements for Endoscopic Ligation Devices

Endoscopic ligation devices are classified as Class B under the Indian MDR, which indicates low to moderate risk. This classification impacts the licensing route:

• Manufacturing License: Requires an MD5 license granted by the State Licensing Authority.
• Import License: Requires an MD15 license granted by the Central Licensing Authority.

For Class B devices, the manufacturing license process involves a test license (MD13), product testing by CDSCO-approved labs, and an audit by a notified body.

Manufacturing License Process for Endoscopic Ligation Devices (MD5 License)

The MD5 license is mandatory for manufacturing Class B devices like endoscopic ligation devices. The process is detailed and involves several key steps:

1. Obtain Test License (Form MD13): Initially, you must apply for a test license to manufacture the device for testing purposes. This phase typically takes 1.5 to 2 months.

2. Product Testing: The devices must be tested at government-approved laboratories to validate compliance with essential principles and safety standards. You can find the list of testing laboratories here.

3. Document Preparation: Prepare comprehensive documentation including device master files, plant master files, risk management files, quality management system (QMS) documents, and more.

4. Application Submission: Apply for the MD5 license through the CDSCO MD Online Portal using Form MD3.

5. Audit by Notified Body: An audit of your manufacturing facility will be conducted by a CDSCO-approved notified body. Refer to the list of notified bodies to select the appropriate auditor.

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

7. License Grant: Upon successful completion of all prior steps, the license will be granted on Form MD5.

Total Timeframe:

The entire MD5 licensing process, including test license, product testing, documentation, audit, and license grant, usually takes 3 to 4 months.

Manufacturing License Documents Required for Endoscopic Ligation Devices

Preparing a robust dossier is crucial for a smooth approval process. The following documents are required:

• Company Constitution/Incorporation Certificate
• Proof of Ownership or Lease Agreement of Manufacturing Premises
• Details and Qualifications of Technical Staff
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF) detailing device design and manufacturing processes (Device Master File Guide)
• Plant Master File (PMF) describing manufacturing site and quality systems (Plant Master File Guide)
• Essential Principles Checklist affirming compliance with safety and performance requirements
• Risk Management File showing hazard identification and mitigation strategies (Risk Management)
• Test Reports from CDSCO-approved labs
• Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documents, preferably ISO 13485:2016 certification

Ensuring these documents are complete and accurately prepared prevents delays during the audit and review stages.

Import License Process for Endoscopic Ligation Devices (MD15 License)

If you import endoscopic ligation devices instead of manufacturing them, you must obtain an MD15 import license from CDSCO’s Central Licensing Authority.

Key steps include:

1. Document Compilation: Gather documents including a valid manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate (if applicable), Device and Plant Master Files, wholesale license, and company constitution.

2. Application Submission: Submit your license application on the CDSCO MD Online Portal using Form MD14.

3. Review and Query Resolution: CDSCO reviews the application and may raise queries that need prompt response.

4. License Grant: Upon satisfactory review, the MD15 license is granted.

Timeline:

The import license process usually takes 5 to 6 months due to extensive documentation verification and procedural formalities.

Import License Documents Required

• Valid Manufacturing License of the Device in the Country of Origin
• Free Sale Certificate or Equivalent
• ISO 13485:2016 Certification
• CE Certificate or Equivalent Quality Mark
• Device Master File
• Plant Master File
• Wholesale License for India
• Company Constitution Documents

Government Fees and Costs for Endoscopic Ligation Devices Licensing

For Class B devices like endoscopic ligation devices, the fee structure for manufacturing (MD5) and import (MD15) licenses is as follows:

MD5 Manufacturing License Fees

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

MD15 Import License Fees

• Site Fee: Approximately $1,000 per site (approx Rs 75,000)
• Product Fee: $50 per product

These fees are subject to change as per CDSCO notifications, so it’s advisable to verify the latest fee schedule on the CDSCO portal.

Common Challenges and Solutions in Licensing Endoscopic Ligation Devices

Challenge 1: Delays in Product Testing

Solution: Engage early with CDSCO-approved labs and book testing slots in advance. Maintain open communication to track progress.

Challenge 2: Incomplete Documentation

Solution: Use detailed checklists and templates for Device and Plant Master Files. Consider expert consultation to ensure compliance.

Challenge 3: Audit Non-Conformities

Solution: Conduct internal mock audits before notified body visits. Train staff on regulatory expectations and documentation readiness.

Challenge 4: Query Resolution Delays

Solution: Designate a regulatory affairs professional to respond promptly and comprehensively to queries.

Expert Consultation and Support for CDSCO Licensing

With our extensive track record in assisting over 500 medical device companies, we offer:

• Regulatory gap assessments
• Preparation of DMF, PMF, and risk management documentation
• Coordination with notified bodies and testing laboratories
• Application filing and follow-up services
• Training and mock audits

Our expert team streamlines your licensing journey, minimizing time and cost overruns.

Getting Started with Your CDSCO License Application for Endoscopic Ligation Devices

Ready to enter the Indian market with your endoscopic ligation device? Here’s a practical roadmap:

1. Confirm Device Classification: Verify that your device is Class B under CDSCO regulations.

2. Gather Required Documents: Begin compiling your company and technical documents, focusing on quality and completeness.

3. Apply for Test License: Submit Form MD13 for a test license via the CDSCO MD Online Portal.

4. Schedule Product Testing: Coordinate with CDSCO-approved labs early to avoid bottlenecks.

5. Prepare for Audit: Select a notified body from the official notified bodies list and prepare for facility audit.

6. Submit MD5 Application: Once testing and documentation are ready, apply for the manufacturing license using Form MD3 on the online portal.

7. Respond to Queries Promptly: Assign clear responsibilities for timely follow-up.

8. Obtain License & Commence Manufacturing: After license grant, maintain compliance with ongoing regulatory requirements.

Our team is here to assist you through each stage with tailored support and expert advice. Contact us to initiate your CDSCO licensing process today!

By following this comprehensive guide, manufacturers and importers of endoscopic ligation devices can confidently navigate the CDSCO licensing pathway, ensuring timely market access while maintaining regulatory compliance.