CDSCO License for Suction antichoke device

Comprehensive Guide to CDSCO Licensing for Suction Antichoke Device (Class C)

In the fast-evolving landscape of medical devices in India, regulatory compliance plays a critical role in ensuring safety and efficacy. As specialists with over 25 years of experience assisting 500+ companies, we understand the nuances of securing CDSCO licenses—especially for life-saving devices like the Suction Antichoke Device. This device is designed to rapidly remove airway obstructions via suction during emergencies, making it a vital tool in ENT care.

CDSCO Regulatory Framework for Suction Antichoke Devices

The Central Drugs Standard Control Organization (CDSCO) governs the regulation of medical devices in India under the Medical Device Rules, 2017. The Suction Antichoke Device falls under the ENT category and is classified as a Class C medical device according to Notification 29/Misc/03/2020-DC(196), dated 06.08.2021. This classification mandates stringent regulatory compliance due to the moderate-to-high risk associated with its intended emergency use.

Risk Classification and License Requirements for Class C Devices

Class C devices like the Suction Antichoke Device require a Manufacturing License MD9, issued by the Central Licensing Authority. This process involves rigorous documentation, testing, and audits to ensure the device meets all safety and performance standards. Importers must obtain an Import License MD15 before marketing in India.

For a detailed overview of medical device classification, we recommend reviewing the Medical Device Classification guide.

Manufacturing License Process (MD9) for Suction Antichoke Device

The MD9 license process is comprehensive and typically spans 4 to 5 months. Here is a step-by-step breakdown:

1. Test License (Form MD13): Before applying for the MD9 license, manufacturers must obtain a Test License to conduct mandatory product testing. This takes approximately 1.5 to 2 months.
2. Product Testing: Tests must be performed at CDSCO-approved laboratories listed in the Testing Laboratories directory. Tests focus on device safety, biocompatibility, and functional performance.
3. Document Preparation: Complete technical documentation, including quality management system (QMS) files and risk management, must be compiled.
4. Application Submission (Form MD7): Submit the MD9 manufacturing license application via the CDSCO MD Online Portal.
5. Audit by CDSCO Inspectors: The manufacturing site undergoes an on-site audit to verify compliance with Good Manufacturing Practices (GMP) and documentation accuracy.
6. Query Resolution: Address any observations or queries raised by CDSCO or auditors promptly.
7. License Grant (Form MD9): Upon successful audit and document verification, the manufacturing license is granted.

Manufacturing License Documents Required

Prepare the following documents meticulously to avoid delays:

• Company Constitution (e.g., Memorandum and Articles of Association)
• Proof of ownership or lease of manufacturing premises
• Details and qualifications of technical staff responsible for manufacturing
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF) detailing design and specifications (Device Master File Guide)
• Plant Master File (PMF) documenting manufacturing facilities and processes (Plant Master File Guide)
• Essential Principles Checklist confirming compliance with safety standards
• Risk Management File outlining hazard analysis and mitigation (Risk Management)
• Test Reports from CDSCO-approved labs
• Device Labels and Instructions for Use (IFU)
• QMS documentation (typically ISO 13485 compliant)

Import License Process (MD15) for Suction Antichoke Device

If you are an importer of the Suction Antichoke Device, the MD15 license is mandatory and administered by the Central Licensing Authority. The process takes approximately 5 to 6 months.

Steps include:

• Document preparation (including manufacturing license of the foreign manufacturer)
• Submission of application via the CDSCO MD Online Portal
• Responding to departmental queries
• Grant of Import License (Form MD15)

Import License Documents Required

Key documents include:

• Foreign manufacturer’s valid manufacturing license
• Free Sale Certificate from the country of origin
• ISO 13485:2016 certification
• CE Certificate or equivalent regulatory approval
• Device Master File and Plant Master File
• Wholesale license in India
• Company Constitution

Timeline and Processing Duration

Government Fees and Costs

For Class C devices like the Suction Antichoke Device, the fee structure is as follows:

• MD9 Manufacturing License: Rs. 50,000 per application + Rs. 1,000 per product
• Test License (MD13): Rs. 5,000 (approximate and may vary)
• Import License (MD15): $3,000 per site +$1,500 per product

Note: Fees are subject to revision; always confirm on the official CDSCO MD Online Portal.

Common Challenges and Solutions

1. Delays in Test License Approval: Often, applicants face delays in obtaining the MD13 test license. To mitigate this, ensure that your test license application is complete with all required documents and submit early.

2. Product Testing Failures: Testing at CDSCO-approved labs can uncover non-compliance issues. Partner with experienced labs and conduct pre-testing internally to avoid surprises.

3. Audit Non-compliance: Manufacturing site audits may raise observations on documentation or GMP practices. Maintain an up-to-date Plant Master File and conduct internal mock audits to prepare.

4. Query Resolution Delays: Respond promptly and comprehensively to CDSCO queries. Establish a dedicated regulatory team or hire consultants to streamline communication.

Expert Consultation and Support

Navigating CDSCO regulations for a Class C device like the Suction Antichoke Device demands expertise. Our seasoned consultants provide end-to-end support—from documentation to audits and license acquisition. We leverage our extensive experience to accelerate approvals and minimize compliance risks.

Explore our specialized MD9 License Guide for in-depth insights.

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm your device is Class C via official CDSCO notifications.
2. Prepare Technical Documentation: Develop Device and Plant Master Files, risk management plans, and QMS documents.
3. Apply for Test License (MD13): Submit your application through the CDSCO MD Online Portal.
4. Coordinate Product Testing: Engage CDSCO-approved laboratories early.
5. Compile Manufacturing License Application: After successful testing, prepare Form MD7 application with all required documents.
6. Schedule and Prepare for Audit: Ensure your manufacturing site adheres to GMP and documentation standards.
7. Engage with Regulatory Experts: Utilize consultants to handle complex queries and expedite the process.

By following these actionable steps and leveraging expert support, manufacturers and importers of the Suction Antichoke Device can confidently navigate the CDSCO licensing process and successfully enter the Indian market.

For more information on licensing procedures and regulatory assistance, feel free to connect with us or explore the official CDSCO MD Online Portal.