CDSCO License for Incentive spirometer

Introduction to Incentive Spirometer and Its Regulatory Importance

The Incentive Spirometer is a vital medical device used in respiratory therapy, primarily designed to encourage patients to perform deep-breathing exercises. This device plays a critical role in post-surgical recovery by preventing atelectasis (lung collapse) and aiding airway clearance. As a Class A medical device categorized under physical support, it is considered low risk but still requires stringent regulatory compliance to ensure patient safety and efficacy.

With the CDSCO notification No. 29/Misc./03/2020-DC (202) dated 26.7.2021, the Incentive Spirometer falls under the regulatory framework that mandates obtaining the appropriate manufacturing or import license before marketing in India. Understanding this regulatory landscape is crucial for manufacturers and importers to avoid delays and penalties.

CDSCO Regulatory Framework for Incentive Spirometer

The Central Drugs Standard Control Organization (CDSCO) governs the licensing and regulation of medical devices in India. For Class A devices like the Incentive Spirometer, the licensing process is managed at the state level through the MD5 license. The regulatory framework involves several key steps including test license acquisition, product testing at government-approved laboratories, documentation submission, audit by notified bodies, and finally, license issuance.

Risk Classification and License Requirements for Class A Medical Devices

Class A devices represent the lowest risk category. The Incentive Spirometer, being a physical support device, is classified as Class A under the CDSCO risk classification system. Manufacturers or importers must obtain an MD5 manufacturing license (application form MD3) from the State Licensing Authority to legally produce this device in India.

For detailed classification guidelines, manufacturers can refer to the Medical Device Classification resource.

Manufacturing License Process (MD5) for Incentive Spirometer

1. Test License (Form MD13): Initially, the manufacturer must apply for a test license that allows product testing. This typically takes 1.5 to 2 months.
2. Product Testing: Samples must be tested at CDSCO-approved laboratories to verify compliance with essential principles. Refer to the Testing Laboratories list for authorized facilities.
3. Document Preparation: Compile all necessary documents including Device Master File, Plant Master File, Risk Management File, and Quality Management System (QMS) documentation.
4. Application Submission: Submit the manufacturing license application (Form MD3) via the CDSCO MD Online Portal.
5. Audit by Notified Body: A notified body conducts an audit of the manufacturing facility. Check the list of notified bodies to select an authorized auditor.
6. Query Resolution: Address any queries raised by the licensing authority or notified body promptly.
7. License Grant: Upon satisfactory compliance, the MD5 license is granted on Form MD5.

Manufacturing License Documents Required for Incentive Spirometer

• Company Constitution (e.g., Memorandum and Articles of Association)
• Proof of ownership or valid lease agreement of manufacturing premises
• Details and qualifications of technical staff
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF) detailing device design and specifications. Our Device Master File guide offers comprehensive insights.
• Plant Master File (PMF) describing manufacturing processes and facilities. Learn more in our Plant Master File guide.
• Essential Principles Checklist confirming compliance with regulatory standards
• Risk Management File demonstrating hazard identification and mitigation strategies. Refer to our Risk Management resource.
• Test Reports from CDSCO-approved laboratories
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documents such as ISO 13485 certification

Import License Process (MD15) for Incentive Spirometer

Although your device is Class A, if you are importing the Incentive Spirometer into India, you must obtain an MD15 import license from the Central Licensing Authority. The process involves:

1. Preparing comprehensive documentation including the manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE certificate, and others.
2. Submitting the application via the CDSCO MD Online Portal.
3. Responding to departmental queries.
4. Awaiting license grant on Form MD15.

For more detailed guidance, consult our Import License Guide.

Import License Documents Required

• Valid manufacturing license of the device in the exporting country
• Free Sale Certificate
• ISO 13485:2016 certification
• CE Certificate (if applicable)
• Device Master File
• Plant Master File
• Wholesale License (if applicable)
• Company Constitution documents

Timeline and Processing Duration

• Test License (MD13): 1.5 to 2 months
• Product Testing: 1 to 1.5 months depending on lab schedules
• MD5 License Application Processing: 1.5 to 2 months including audit and query resolution

Total estimated duration: Approximately 3 to 4 months from test license application to MD5 license grant.

For imports, the MD15 license may take between 5 to 6 months.

Government Fees and Costs

• MD5 Manufacturing License: Rs. 5,000 per application plus Rs. 500 per product
• Test License (MD13): Fees are included in the application process but confirm with state authority for exact charges
• Import License (MD15): Fees vary by device class; for Class A, approximately $1000 per site and$50 per product

These fees are subject to change, so always verify on the CDSCO MD Online Portal before application.

Common Challenges and Solutions

• Delayed Testing Results: Opt for laboratories with shorter turnaround times from the CDSCO-approved Testing Laboratories.
• Incomplete Documentation: Use comprehensive checklists and templates for Device Master File and Plant Master File to avoid rejections.
• Audit Non-Compliance: Conduct internal mock audits to ensure readiness before the notified body visit.
• Query Resolution Delays: Assign a dedicated regulatory expert to respond promptly and accurately to licensing authority queries.

Expert Consultation and Support

With over 25 years of experience assisting 500+ companies, we provide end-to-end regulatory consulting for CDSCO licensing. Our expertise includes document preparation, audit readiness, test license facilitation, and strategic planning to minimize approval timelines.

Getting Started with Your CDSCO License Application for Incentive Spirometer

1. Assess your product classification: Confirm your device as Class A.
2. Initiate the test license application (Form MD13): Begin documentation and sample submission to a CDSCO-approved lab.
3. Prepare your Device and Plant Master Files: Utilize our detailed guides to ensure compliance.
4. Submit your application via the CDSCO MD Online Portal: Register and upload your documents.
5. Coordinate with a notified body for the required audit: Choose from the official list of notified bodies.
6. Plan for timely query responses and audit preparations: Stay proactive to avoid delays.

By following these precise steps tailored for the Incentive Spirometer, you can confidently navigate the CDSCO licensing process and successfully enter the Indian medical device market.