CDSCO License for Tongs antichoke device

Introduction to Tongs Antichoke Device and Regulatory Importance

A Tongs Antichoke Device plays a critical role in emergency medical care by enabling healthcare professionals to swiftly grasp and remove foreign objects obstructing a patient’s airway, thereby preventing asphyxiation. Classified under the ENT category, this device is life-saving and demands stringent regulatory compliance for market entry in India.

Given its classification as a Class C device, the regulatory process is governed by the Central Drugs Standard Control Organisation (CDSCO) under the Ministry of Health and Family Welfare. Ensuring compliance with CDSCO norms not only guarantees patient safety but also facilitates smooth commercialization and distribution within India’s vast healthcare market.

CDSCO Regulatory Framework for Tongs Antichoke Device

The CDSCO oversees the approval and licensing of medical devices to maintain high safety and quality standards. Since the Tongs Antichoke Device falls under Class C as per the notification 29/Misc/03/2020-DC(196) dated 06.08.2021, the regulatory framework mandates obtaining an MD9 manufacturing license for producing this device in India.

Class C devices are considered moderate to high risk and require central licensing authority approval, including comprehensive testing, documentation, and audits.

Risk Classification and License Requirements

• Device Name: Tongs Antichoke Device
• Risk Class: C (Moderate to High Risk)
• Category: ENT
• License Type: MD9 Manufacturing License (Application Form MD7)
• Regulatory Authority: CDSCO Central Licensing Authority

The MD9 license is mandatory for manufacturing Class C devices domestically and involves multiple phases such as test licensing, product testing, document submission, and audit.

Manufacturing License Process for MD9 (Class C Device)

1. Test License Application (Form MD13): Initiate the process by applying for a test license, which typically takes 1.5 to 2 months to be granted.
2. Product Testing: Conduct mandatory product testing at CDSCO-approved laboratories to verify compliance with Indian standards. Refer to the Testing Laboratories list for authorized facilities.
3. Documentation Preparation: Compile all technical files including Device Master File (DMF), Plant Master File (PMF), Risk Management File, and Quality Management System (QMS) documents.
4. License Application Submission (Form MD7): Submit the complete application via the CDSCO MD Online Portal for the MD9 license.
5. Audit Inspection: CDSCO inspectors conduct a detailed audit of your manufacturing facility and documentation.
6. Resolution of Queries: Address any observations or queries raised during the audit or by the CDSCO department.
7. Grant of Manufacturing License (Form MD9): Upon satisfactory review and compliance, the license is granted.

The entire process generally spans 4 to 5 months from initiation to license grant.

Manufacturing License Documents Required for MD9

To ensure a smooth approval process, the following documents must be meticulously prepared and submitted:

• Company Constitution (e.g., Incorporation Certificate, MOA/AOA)
• Proof of Ownership or Lease of Manufacturing Premises
• Details and Qualifications of Technical Staff
• Fire Safety NOC
• Pollution Control Board NOC
• Device Master File (DMF) – Refer to our detailed Device Master File guide
• Plant Master File (PMF) – Learn how to prepare through our Plant Master File Guide
• Essential Principles Checklist
• Risk Management File – Implement risk management compliant with ISO 14971 (Risk Management Guide)
• Product Test Reports from CDSCO-approved labs
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) Documents (ISO 13485:2016 certification)

Ensuring completeness and accuracy in documentation can significantly reduce processing delays.

Import License Process for Tongs Antichoke Device (MD15)

For companies planning to import the Tongs Antichoke Device, an MD15 license is mandatory. This license is granted by the Central Licensing Authority and usually takes 5 to 6 months.

Key steps include:

• Preparation of comprehensive documentation including Manufacturing License from country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate, DMF, PMF, and Wholesale License.
• Submission of the application on the CDSCO MD Online Portal.
• Addressing any queries raised by the department.
• Grant of Import License (Form MD15).

Note that unlike manufacturing, no test license is required for imports.

Import License Documents Required

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

Consult our Import License Guide for an in-depth walkthrough.

Timeline and Processing Duration

Manufacturers should plan for approximately 4 to 5 months to obtain the MD9 license for Class C devices like the Tongs Antichoke Device.

Government Fees and Costs

• MD9 License:

  • Application Fee: ₹50,000 per license
  • Product Fee: ₹1,000 per product

• Test License (MD13): Included in the process

• Import License (MD15): Fees vary based on class and product count; for Class C & D devices, fees are typically $3,000 per site +$1,500 per product.

Budgeting for these fees upfront helps avoid financial surprises.

Common Challenges and Practical Solutions

Challenge 1: Delays in Test License Approval

• Solution: Ensure your application is complete with correct forms and fees. Early engagement with CDSCO officials can expedite queries.

Challenge 2: Product Testing Failures

• Solution: Conduct pre-testing at accredited private labs before government testing to identify non-compliance early.

Challenge 3: Audit Non-Compliance

• Solution: Maintain updated QMS and ensure all documentation matches actual practices. Conduct internal audits prior to CDSCO inspection.

Challenge 4: Document Preparation Overwhelm

• Solution: Utilize expert consultants and refer to detailed guides such as our MD9 License Guide and master file preparation resources.

Expert Consultation and Support

With over 25 years of experience assisting 500+ companies in obtaining CDSCO licenses, we offer tailored support including:

• Gap analysis and readiness assessment
• Document preparation and review
• Liaison with CDSCO authorities and notified bodies
• Pre-audit training and mock inspections
• End-to-end project management

Our proactive approach mitigates risks and accelerates your path to market.

Getting Started with Your CDSCO MD9 License Application for Tongs Antichoke Device

1. Conduct a Classification Confirmation: Verify the Class C risk categorization with CDSCO notifications or consult our Medical Device Classification resource.
2. Apply for Test License: Submit Form MD13 through the CDSCO MD Online Portal and prepare your product for mandatory testing.
3. Select Government-Approved Testing Laboratory: Choose from the official Testing Laboratories list.
4. Prepare Comprehensive Documentation: Assemble your DMF, PMF, Risk Management File, and QMS documents following our guides.
5. Schedule Pre-Audit Checks: Conduct internal audits or hire consultants to ensure compliance.
6. Submit MD9 Application: Upload your complete application on the CDSCO portal and track progress.

Starting early and maintaining consistent follow-up significantly enhances the likelihood of a timely license grant.

For personalized assistance or detailed queries regarding the Tongs Antichoke Device or other Class C medical devices, contact our regulatory experts who can guide you through every step of the CDSCO licensing journey.