CDSCO License for Chest-oscillation airway secretion-clearing system

Introduction to Chest-Oscillation Airway Secretion-Clearing System and Regulatory Importance

The Chest-oscillation airway secretion-clearing system is a specialized respiratory medical device designed to provide high frequency chest wall oscillation (HFCWO). Its primary function is to aid in loosening excessive airway secretions, promoting effective airway clearance, and improving bronchial drainage in patients suffering from respiratory diseases. Given its critical role in respiratory therapy, regulatory compliance with India's Central Drugs Standard Control Organization (CDSCO) is mandatory for manufacturers and importers aiming to market this device in India.

Compliance ensures patient safety, device efficacy, and legal market access. With over 25 years of expertise and having supported 500+ medical device companies, we understand the nuances of this process and provide you with a detailed roadmap tailored for your device.

CDSCO Regulatory Framework for Respiratory Devices like Chest-Oscillation Systems

The CDSCO regulates medical devices through risk-based classification, licensing, and post-market surveillance. Respiratory devices such as the Chest-oscillation airway secretion-clearing system are categorized under Class B medical devices, as per the CDSCO notification (File No. 29/Misc/03/2020-DC(197), dated 6.8.2021).

The device must comply with the Essential Principles of Safety and Performance, undergo quality management system certification (ISO 13485:2016), and follow the prescribed licensing pathway to ensure adherence to Indian regulatory standards.

Risk Classification and License Requirements for Class B Devices

Class B devices fall under the low to moderate risk category and require an MD5 Manufacturing License issued by the State Licensing Authority. The MD5 license process involves:

• Obtaining a Test License (Form MD13) initially
• Conducting mandatory product testing at CDSCO-approved laboratories
• Document preparation and submission
• Audit by an authorized notified body
• Resolution of any departmental or audit queries
• Final grant of manufacturing license (Form MD5)

For detailed classification, you can refer to our comprehensive Medical Device Classification guide.

Manufacturing License Process (MD5) for Chest-Oscillation Airway Secretion-Clearing Systems

Step 1: Application for Test License (Form MD13)

Before applying for the manufacturing license, you must obtain a test license. This allows you to legally manufacture the device for testing purposes.

• Timeline: Approximately 1.5 to 2 months
• Action: Submit Form MD13 on the CDSCO MD Online Portal

Step 2: Product Testing

Post test license approval, the device must be tested at CDSCO-approved labs to validate performance and safety.

• Use the list of Testing Laboratories recognized by CDSCO.
• Testing typically takes 4-6 weeks depending on the lab’s workload.

Step 3: Document Preparation

Prepare and collate all mandatory documents, including technical files, quality system documents, and compliance evidence.

Step 4: Application for Manufacturing License (Form MD3)

Submit your application for the MD5 license with all supporting documents.

Step 5: Audit by Notified Body

An audit of your manufacturing facility and quality management system is conducted by a CDSCO-notified body. Refer to the Notified Bodies List for authorized agencies.

Step 6: Query Resolution and License Grant

Address any clarifications or queries raised during the audit or by CDSCO officials promptly. Upon satisfactory compliance, the MD5 license is granted.

For a detailed walkthrough, see our dedicated MD5 License Guide.

Manufacturing License Documents Required for Class B Respiratory Devices

For the Chest-oscillation airway secretion-clearing system, the following documents are mandatory:

• Company Constitution Documents: Incorporation certificate, partnership deed, MOA/AOA
• Proof of Ownership or Lease of Manufacturing Premises
• Technical Staff Details: Qualification and experience certificates for technical personnel
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF): Detailed device specifications, design, and manufacturing process (Device Master File Guide)
• Plant Master File (PMF): Description of manufacturing facilities and quality control (Plant Master File Guide)
• Essential Principles Checklist: Compliance matrix with regulatory safety requirements
• Risk Management File: Evidence of risk analysis and mitigation for the device (Risk Management Guide)
• Test Reports: From CDSCO-approved testing laboratories
• Labels and Instructions for Use (IFU): Sample labels and user manuals
• Quality Management System Documents: ISO 13485:2016 certification and internal SOPs

Ensuring accuracy and completeness in these documents is crucial for a smooth licensing process.

Import License Process (MD15) for Chest-Oscillation Devices

If you are an importer, an MD15 import license is mandatory for bringing the device into India.

Process Overview:

• Prepare all required documentation, including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device Master File, Plant Master File, wholesale license, and company constitution.
• Submit the application on the CDSCO MD Online Portal.
• Respond to any queries raised by the CDSCO.
• Upon approval, the MD15 license is issued.

Timeline and Fees:

• Timeline: Approximately 5-6 months
• Government Fees: For Class B devices, Rs. 1,50,000 per site and Rs. 50,000 per product approximately

For more detailed guidance, explore our Import License Guide.

Timeline and Processing Duration

Total Time: Approximately 3 to 4 months for complete MD5 license acquisition.

Government Fees and Costs for MD5 License

• Application Fee: Rs. 5,000 per application
• Product Fee: Rs. 500 per product
• Additional costs may include notified body audit fees and testing charges which vary by agency and number of devices tested.

Common Challenges and Solutions

• Incomplete Documentation: Prepare a comprehensive checklist and cross-verify documents before submission to avoid delays.
• Audit Non-Compliance: Conduct internal pre-audit assessments to ensure readiness.
• Delayed Test Reports: Engage with CDSCO-approved labs early and confirm timelines.
• Query Resolution Delays: Assign a dedicated regulatory contact to manage prompt responses.

Our hands-on experience with over 500 successful cases enables us to navigate these challenges effectively.

Expert Consultation and Support

Navigating the CDSCO licensing process can be complex given the technical and regulatory nuances. We provide end-to-end consultancy services including:

• Regulatory strategy and classification
• Documentation support (DMF, PMF, Risk Management)
• Test license and manufacturing license application assistance
• Coordination with notified bodies and testing labs
• Post-approval compliance and renewals

Engage with our experts to streamline your journey into the Indian medical device market.

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm Class B designation under CDSCO guidelines.
2. Register on CDSCO MD Online Portal: Create an account for submissions.
3. Prepare Test License Application (MD13): Collect necessary documents and submit.
4. Identify CDSCO-Approved Testing Lab: Schedule device testing promptly.
5. Compile Technical Documentation: Align with DMF and PMF requirements.
6. Select Notified Body for Audit: Coordinate audit scheduling.
7. Apply for Manufacturing License (MD5): Submit complete application with all documents.
8. Respond to Queries: Maintain prompt communication with CDSCO.

Starting early and maintaining compliance with timelines can significantly reduce approval delays. For detailed assistance, connect with us and leverage our 25+ years of regulatory expertise.

For further resources and updates, visit the CDSCO MD Online Portal and consult the notified bodies and testing labs directories linked above.