CDSCO License for Chest-percussion airway secretion-clearing system

Comprehensive Guide to CDSCO License for Chest-Percussion Airway Secretion-Clearing System (Class B)

Manufacturers and importers aiming to market a Chest-percussion airway secretion-clearing system in India must navigate the CDSCO regulatory framework carefully. This respiratory device, designed to provide external mechanical percussion to loosen airway secretions, falls under Class B risk category. With over 25 years of experience assisting 500+ companies, we provide a detailed, practical roadmap for obtaining your CDSCO license seamlessly.

Understanding the CDSCO Regulatory Framework for Respiratory Devices

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India to ensure safety, quality, and efficacy. Respiratory devices like the chest-percussion airway secretion-clearing system are classified based on risk, which defines the licensing pathway. Since this device is Class B, it requires a manufacturing license known as MD5, issued by the State Licensing Authority.

Risk Classification and License Requirements for Chest-Percussion Airway Devices

India classifies medical devices into four risk classes (A to D). The chest-percussion airway secretion-clearing system, being Class B, poses a moderate risk, necessitating an MD5 manufacturing license. This classification dictates the documentation, audit, and testing procedures:

• Class B Devices: Require MD5 license (Form MD3 application)
• Issuing Authority: State Licensing Authority
• Process Duration: Approximately 3-4 months
• Initial Step: Test license (Form MD13) for 1.5-2 months

For a detailed classification overview, you may refer to our Medical Device Classification guide.

Manufacturing License Process for MD5 (Class B Devices)

The MD5 license process involves several key stages:

1. Obtain Test License (Form MD13): Before full manufacturing license, a test license is mandatory to allow product testing from government-approved labs.
2. Product Testing: Submit samples to notified testing laboratories to verify compliance with essential principles.
3. Document Preparation: Compile comprehensive technical documentation including Device Master File, Plant Master File, and Risk Management File.
4. Application Submission: File the MD5 license application (Form MD3) via the CDSCO MD Online Portal.
5. Notified Body Audit: Engage a notified body from the official list for a thorough audit of your manufacturing facility and quality systems.
6. Query Resolution: Address any observations raised by the CDSCO or notified body promptly.
7. License Issuance: Upon satisfactory compliance, the State Licensing Authority grants the MD5 license (Form MD5).

Essential Documents Required for MD5 Manufacturing License

For your chest-percussion airway secretion-clearing system, ensure you have the following documents ready and well-organized:

• Company Constitution Documents (Incorporation certificate, partnership deed, etc.)
• Proof of Premises Ownership or Lease Agreement
• Technical Staff Qualification and Experience Certificates
• Fire NOC and Pollution Control NOC
• Device Master File (DMF): Detailed product description, design, and manufacturing process (Device Master File guide)
• Plant Master File (PMF): Information about the manufacturing facility and quality control (Plant Master File guide)
• Essential Principles Compliance Checklist
• Risk Management File: Documented risk analysis and mitigation plan (Risk Management resource)
• Test Reports from government-approved laboratories (Testing Laboratories list)
• Labels and Instructions for Use (IFU)
• Quality Management System (QMS) Documents: ISO 13485 certification and related records

Import License Process (MD15) for Chest-Percussion Devices

If you are an importer rather than a manufacturer, the import license (MD15) is required. This is granted by the Central Licensing Authority and typically takes 5-6 months. Unlike manufacturing licenses, no test license is needed upfront.

Documents Required for MD15 Import License:

• Valid manufacturing license from the country of origin
• Free Sale Certificate
• ISO 13485:2016 certification
• CE Certificate (if applicable)
• Device Master File and Plant Master File
• Wholesale drug license
• Company constitution documents

Application is submitted through the same CDSCO MD Online Portal.

Timeline and Processing Duration

For manufacturers of this Class B respiratory device, expect the following timeline:

• Test License (MD13): 1.5 to 2 months
• Product Testing: 3 to 4 weeks
• Application Preparation: 2 to 3 weeks
• Notified Body Audit: Scheduled within 1 month after application
• Query Resolution and Final Approval: 3 to 4 weeks

Overall, the entire MD5 licensing process generally spans 3-4 months.

Government Fees and Cost Structure

The fee structure is as follows:

• Application Fee: Rs 5,000 per MD5 license application
• Product Fee: Rs 500 per product

Additional expenses include testing fees at government-approved laboratories and notified body audit charges, which vary depending on the scope.

Common Challenges and Practical Solutions

Challenge 1: Delays in Product Testing

• Solution: Engage testing labs early, provide complete samples and documentation to avoid back-and-forth.

Challenge 2: Incomplete Documentation

• Solution: Use standardized templates for Device Master File and Plant Master File to ensure compliance. Our Device Master File guide can help streamline this.

Challenge 3: Notified Body Audit Non-compliance

• Solution: Conduct internal audits before the official audit; ensure your QMS and facility meet CDSCO requirements.

Challenge 4: Query Resolution Delays

• Solution: Assign a dedicated regulatory liaison to respond promptly and comprehensively to all CDSCO queries.

Expert Consultation and Support

Navigating CDSCO licensing can be complex, especially for specialized respiratory devices. With our extensive track record, we help clients:

• Prepare and review technical files
• Liaise with notified bodies and testing labs
• Manage timelines and documentation
• Provide training on regulatory compliance

Our expert guidance reduces approval times and prevents costly rejections.

Getting Started with Your CDSCO MD5 License Application

1. Register on the CDSCO MD Online Portal.
2. Apply for the Test License (Form MD13) immediately to initiate product testing.
3. Simultaneously, prepare your Device Master File, Plant Master File, and Risk Management File.
4. Identify a notified body from the official list and schedule a pre-audit assessment.
5. Gather all statutory documents including fire and pollution NOCs.
6. Submit the MD5 application (Form MD3) online once testing is complete.
7. Stay proactive in addressing queries and audit observations.

Embarking on your journey with a clear, step-wise approach ensures your chest-percussion airway secretion-clearing system reaches the Indian market efficiently and compliantly. Reach out to us for tailored regulatory support based on 25+ years of CDSCO licensing expertise.