CDSCO License for Manual chest percussor

Introduction: Manual Chest Percussor and Regulatory Importance in India

The Manual Chest Percussor is a vital respiratory device designed to assist patients with respiratory diseases by facilitating manual percussion, helping loosen airway secretions and improve bronchial drainage. Given its direct clinical application and moderate risk profile, this device falls under Class B risk classification according to CDSCO guidelines. Navigating the Indian regulatory landscape to obtain the necessary manufacturing or import license is critical for market access, patient safety, and compliance.

With over 25 years of experience and having supported more than 500 medical device companies, we understand the nuances and challenges manufacturers and importers face. This comprehensive guide offers actionable insights specific to your Manual Chest Percussor, ensuring you can confidently pursue your CDSCO license without unnecessary delays or hurdles.

CDSCO Regulatory Framework for Manual Chest Percussor (Class B Device)

The Central Drugs Standard Control Organization (CDSCO) governs the regulation of medical devices in India through a risk-based classification system. Manual Chest Percussors, as Class B devices, are considered low-to-moderate risk and require a manufacturing license (MD5) issued by the State Licensing Authority.

This regulatory framework mandates adherence to quality, safety, and efficacy standards, including compliance with Essential Principles, implementation of a Quality Management System (QMS), and submission of detailed technical documentation.

Risk Classification and License Requirements for Manual Chest Percussor

• Risk Class: B (Low to moderate risk)
• License Type: MD5 Manufacturing License (Form MD3)
• Licensing Authority: State Licensing Authority
• Relevant Notification: File No. 29/Misc/03/2020-DC(197), dated 6.8.2021

Class B devices like the Manual Chest Percussor require a structured process including a test license (MD13), product testing from government-approved laboratories, audit by a notified body, and final license grant.

For more on classification, refer to our detailed Medical Device Classification guide.

Manufacturing License Process (MD5) for Manual Chest Percussor

1. Obtain Test License (Form MD13): This initial step authorizes testing of your device. Expect approximately 1.5 to 2 months for processing.

2. Product Testing: Conduct mandatory testing at CDSCO-approved laboratories to produce compliance reports. A list of Testing Laboratories is available for selection.

3. Document Preparation: Assemble all required documentation, including your Device Master File and Plant Master File.

4. Apply for Manufacturing License (Form MD3): Submit your complete application through the CDSCO MD Online Portal.

5. Notified Body Audit: Coordinate with a notified body for a thorough audit of your manufacturing facility and QMS. Check the Notified Bodies List for authorized auditors.

6. Resolution of Queries: Promptly address any observations or queries raised by CDSCO or the notified body.

7. License Grant (Form MD5): Upon satisfactory compliance, your manufacturing license will be granted.

For a step-by-step breakdown, see our MD5 License Guide.

Manufacturing License Documents Required for Manual Chest Percussor

To streamline your application, ensure you prepare the following mandatory documents:

• Company Constitution (Partnership deed/MoA & AoA)
• Proof of ownership or lease agreement of manufacturing premises
• Details and qualifications of technical staff
• Fire No Objection Certificate (NOC)
• Pollution Control Board NOC
• Device Master File detailing design, specifications, and manufacturing process (Device Master File Guide)
• Plant Master File outlining manufacturing facility and quality management systems (Plant Master File Guide)
• Essential Principles Compliance Checklist
• Risk Management File demonstrating hazard analysis and mitigation (Risk Management)
• Test Reports from CDSCO-approved labs
• Labels and Instructions for Use (IFU)
• Quality Management System documents (ISO 13485 certifications, SOPs, etc.)

Import License Process (MD15) for Manual Chest Percussor

If you plan to import Manual Chest Percussors into India, the process involves obtaining the MD15 import license from the Central Licensing Authority.

Key steps include:

• Document Preparation: Collate manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certificate, CE certificate, and other device master documentation.

• Application Submission: Apply on the CDSCO MD Online Portal with Form MD14.

• Query Resolution: Address any queries raised during evaluation.

• Grant of Import License: Upon approval, license Form MD15 is issued.

For detailed guidance, see our Import License Guide.

Import License Documents Required

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

Timeline and Processing Duration

• Test License (MD13): 1.5 to 2 months
• Product Testing: 3 to 4 weeks depending on lab workload
• Document Preparation & Review: 2 to 3 weeks
• Application Processing (MD5 License): 3 to 4 months including audit and query resolution

Total Estimated Duration: Approximately 3 to 4 months from test license initiation to manufacturing license grant.

Import licenses (MD15) typically take 5 to 6 months given the central authority’s involvement and document scrutiny.

Government Fees and Costs for Manual Chest Percussor CDSCO License

• MD5 License:

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

• MD13 Test License: Fees vary by state but generally included in MD5 application process

• Audit Costs: Negotiated with notified bodies (varies, typically INR 50,000 to 1,00,000)

• Product Testing Costs: Variable depending on tests required and laboratory rates

• Import License (MD15):

  • Class B devices: Rs. 2,000 per site, Rs. 1,000 per product

Budgeting for these fees upfront helps avoid surprises and ensures smooth processing.

Common Challenges and Solutions

• Incomplete Documentation: Many applicants face delays due to missing or improperly prepared documentation. Using our comprehensive checklists and templates ensures completeness.

• Delayed Test Reports: Opt for government-approved labs with shorter turnaround times and confirm testing scope early.

• Non-Compliance in Audits: Pre-audit internal assessments and engaging notified bodies early can mitigate compliance risks.

• Query Resolution Delays: Assign dedicated regulatory personnel to respond promptly and thoroughly to CDSCO queries.

• Understanding Regulatory Updates: Stay updated with CDSCO notifications and amendments impacting device classifications and processes.

Expert Consultation and Support

Our team has successfully guided over 500 companies through the CDSCO licensing maze. We offer:

• End-to-end license application support for MD5 and MD15
• Document preparation and review
• Coordination with notified bodies and testing labs
• Regulatory strategy tailored to your device and business model

Engaging expert consultants significantly reduces processing time and enhances approval success rates.

Getting Started with Your CDSCO License Application for Manual Chest Percussor

1. Assess Your Device Classification: Confirm your Manual Chest Percussor is Class B using the CDSCO framework.

2. Gather Initial Documents: Begin compiling company constitution, premises proof, and technical staff details.

3. Plan for Testing: Contact approved labs early to understand testing requirements.

4. Register on the CDSCO MD Online Portal: Submit your test license application (Form MD13) via CDSCO MD Online Portal.

5. Prepare Device and Plant Master Files: Utilize our guides to create robust technical documentation.

6. Engage a Notified Body: Select from the Notified Bodies List and schedule an audit.

7. Maintain Quality Systems: Implement ISO 13485 and risk management processes to ensure compliance.

8. Monitor Application Progress: Stay proactive in query responses and documentation updates.

By following these targeted steps, you can confidently navigate the regulatory pathway for your Manual Chest Percussor and bring your device to the Indian market efficiently and compliantly.