CDSCO License for Tracheostoma protective filter

Comprehensive Guide to CDSCO Licensing for Tracheostoma Protective Filter (Class A Medical Device)

As seasoned regulatory consultants with over 25 years of experience and having supported more than 500 medical device companies, we understand the intricacies involved in obtaining CDSCO licenses in India. This guide focuses on the Tracheostoma protective filter, a Class A respiratory device designed to safeguard stomal openings in the windpipe from harmful external influences.

Understanding the Tracheostoma Protective Filter and Its Regulatory Importance

The Tracheostoma protective filter is a vital respiratory accessory that helps maintain airway hygiene and prevents infection or particulate ingress through the tracheostoma. Given its direct contact with the respiratory system, regulatory compliance ensures safety, efficacy, and quality, which are paramount for patient health.

In India, medical devices like this fall under the purview of the Central Drugs Standard Control Organisation (CDSCO), which mandates licensing aligned with device risk classification.

CDSCO Regulatory Framework for Tracheostoma Protective Filter

This device is categorized under Class A (low risk) as per the CDSCO classification, falling under the Respiratory device category. The relevant notification governing this device is File No. 29/Misc/03/2020-DC(197), dated 6th August 2021.

Manufacturers of Class A devices require an MD5 manufacturing license issued by the State Licensing Authority. Importers need an MD15 import license from the Central Licensing Authority.

Risk Classification and License Requirements

• Device Risk Class: A (Low Risk)
• License Type: MD5 Manufacturing License (for domestic manufacturers)
• Test License: MD13 (mandatory before MD5)
• Regulatory Authority: State Licensing Authority for manufacturing; Central Licensing Authority for import

For a detailed understanding of medical device classification, manufacturers can refer to our Medical Device Classification guide.

Manufacturing License Process for Tracheostoma Protective Filter (MD5 License)

The MD5 license process is structured and involves several sequential steps:

1. Apply for Test License (Form MD13): This allows initial product testing and validation. Processing typically takes 1.5 to 2 months.
2. Product Testing: Conduct mandatory product tests at CDSCO-approved labs. Refer to the Testing Laboratories list for authorized facilities.
3. Document Preparation: Compile required documents such as Device Master File, Plant Master File, Risk Management File, etc.
4. Submit Application for MD5 License (Form MD3): Apply through the CDSCO MD Online Portal.
5. Audit by Notified Body: Engage a notified body for facility audit. Check the Notified Bodies list for audits.
6. Resolve Queries: Address any queries from the licensing authority or notified body.
7. Grant of MD5 License (Form MD5): Upon satisfaction, the license is issued.

The entire process typically takes 3 to 4 months.

Manufacturing License Documents Required for MD5 Application

For Tracheostoma protective filters, the following documents are essential:

• Company Constitution (Incorporation Certificate, Partnership Deed, etc.)
• Proof of Ownership or Lease of Manufacturing Premises
• Qualification and Experience Documents of Technical Staff
• Fire NOC and Pollution Control NOC
• Device Master File (DMF): Detailed product design, specifications, and manufacturing process. Learn more in our Device Master File guide.
• Plant Master File (PMF): Facility details, quality systems. See our Plant Master File guide.
• Essential Principles Checklist confirming compliance with Indian regulations
• Risk Management File outlining risk analysis and mitigation strategies. For best practices, visit our Risk Management resource.
• Test Reports from CDSCO-approved laboratories
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) Documentation, preferably ISO 13485 certified

Import License Process for Tracheostoma Protective Filter (MD15 License)

Importers intending to bring this device into India must apply for an MD15 import license through the Central Licensing Authority. The steps include:

1. Document Compilation: No test license is required for import.
2. Application Submission: Use Form MD14 on the CDSCO MD Online Portal.
3. Queries Resolution: Address any government queries promptly.
4. License Grant: MD15 license is granted.

The timeline for import licensing generally spans 5 to 6 months.

Import License Documents Required

• Valid Manufacturing License from the country of origin
• Free Sale Certificate from the exporting country
• ISO 13485:2016 Certification
• CE Certificate or equivalent international certification
• Device Master File and Plant Master File
• Wholesale License
• Company Constitution and Board Resolution

Timeline and Processing Duration

Government Fees and Costs

For the Tracheostoma protective filter (Class A device), the fee structure is as follows:

• MD5 Manufacturing License: Rs. 5,000 per application + Rs. 500 per product
• MD13 Test License: Included in MD5 process costs
• MD15 Import License: Approximately $1,000 per site +$50 per product

These fees are payable through the CDSCO MD Online Portal.

Common Challenges and Practical Solutions

• Delay in Product Testing: Choose CDSCO-approved laboratories with shorter lead times. Early scheduling is key.
• Incomplete Documentation: Use comprehensive checklists and templates. Our Device Master File guide and Plant Master File guide provide detailed frameworks.
• Audit Non-compliance: Prepare in advance with mock audits and internal quality system reviews.
• Query Resolution Delays: Maintain proactive communication with authorities to clarify doubts promptly.

Expert Consultation and Support

With decades of experience, we assist manufacturers and importers by:

• Guiding document preparation tailored to Tracheostoma protective filters
• Coordinating test laboratory engagements
• Facilitating audits with notified bodies
• Managing application submissions and follow-ups

Our expertise ensures smoother approval paths and faster market entry.

Getting Started with Your CDSCO License Application

To initiate your CDSCO licensing process for the Tracheostoma protective filter:

1. Register on the CDSCO MD Online Portal: Start by creating an account at the CDSCO MD Online Portal.
2. Determine Exact Product Classification: Confirm your device’s risk class.
3. Prepare and Submit Test License (MD13) Application: This is mandatory before MD5.
4. Engage with a Notified Body: Early engagement helps streamline audits.
5. Compile Complete Documentation: Use our guides to ensure no gaps.
6. Submit MD5 Application and Track Progress: Monitor your application status online.

For importers, begin by collecting all necessary international certifications and submit your MD15 application accordingly.

Following these actionable steps will help you navigate the regulatory landscape efficiently and bring your Tracheostoma protective filter to the Indian market with confidence.