CDSCO License for Cold-air diagnostic inhalation system

Comprehensive Guide to Obtaining CDSCO License for Cold-Air Diagnostic Inhalation Systems (Class B)

Cold-air diagnostic inhalation systems play a vital role in respiratory healthcare, especially for assessing patients suffering from asthma. As an assembly of devices used clinically in respiratory diagnostics, these systems fall under the Class B risk category according to CDSCO regulations. Navigating the regulatory framework for such medical devices is crucial for manufacturers and importers aiming to enter the Indian market compliantly and efficiently.

With over 25 years of experience assisting 500+ companies in obtaining CDSCO licenses, we provide you with an expert-level, step-by-step guide tailored specifically to Cold-air diagnostic inhalation systems.

CDSCO Regulatory Framework for Cold-Air Diagnostic Inhalation Systems

The Central Drugs Standard Control Organisation (CDSCO) governs the import, manufacture, and sale of medical devices in India. Cold-air diagnostic inhalation systems are categorized under respiratory devices and notified under File No. 29/Misc/03/2020-DC(197), dated 6.8.2021. Because of their moderate risk (Class B), these devices require a State Licensing Authority-issued MD5 manufacturing license.

Risk Classification and License Requirements for Class B Devices

CDSCO classifies medical devices into four classes - A, B, C, and D - based on risk. Class B devices, like cold-air diagnostic inhalation systems, are low to moderate risk and require adherence to specific regulatory requirements:

• Manufacturing License: MD5 license (Form MD3 application) from the State Licensing Authority
• Test License: MD13 test license before manufacturing
• Product Testing: Mandatory testing from government-approved laboratories
• Audit: Conducted by notified bodies for quality management system compliance

Manufacturing License Process (MD5) for Cold-Air Diagnostic Inhalation Systems

Obtaining the MD5 license involves several sequential steps:

1. Apply for MD13 Test License: Submit application on the CDSCO MD Online Portal for a test license. This initial phase typically takes 1.5 to 2 months.

2. Product Testing: Get the device tested at government-approved labs listed on the CDSCO portal (Testing Laboratories) to ensure compliance with essential principles.

3. Prepare Documentation: Assemble comprehensive documentation including Device Master File, Plant Master File, Essential Principles Checklist, Risk Management File, and QMS documents.

4. Apply for MD5 License (Form MD3): Submit the manufacturing license application through the online portal.

5. Audit by Notified Body: Engage a notified body from the official list for an audit of quality management systems and manufacturing premises.

6. Respond to Queries: Address any queries or observations raised by the licensing authority or the notified body.

7. Grant of License: Upon satisfactory evaluation, the MD5 license is issued on Form MD5.

Manufacturing License Documents Required

To ensure smooth processing, prepare the following key documents:

• Company Constitution: Incorporation certificate, partnership deed, or equivalent
• Proof of Premises Ownership: Rent agreement or sale deed
• Technical Staff Details: Qualifications and experience certificates
• Fire NOC and Pollution Control NOC: From local authorities
• Device Master File (DMF): Detailed design and manufacturing information (Device Master File Guide)
• Plant Master File (PMF): Details of manufacturing facility and quality controls (Plant Master File Guide)
• Essential Principles Checklist: Compliance with Indian regulatory guidelines
• Risk Management File: Hazard analysis and mitigation strategies (Risk Management)
• Test Reports: From CDSCO-approved labs
• Labels and Instructions for Use (IFU): As per CDSCO requirements
• Quality Management System Documents: ISO 13485:2016 certification and SOPs

Import License Process (MD15) for Cold-Air Diagnostic Inhalation Systems

While your device is Class B and primarily requires an MD5 manufacturing license, importers must obtain an MD15 import license from the Central Licensing Authority if sourcing from outside India.

The process includes:

1. Document Preparation: Manufacturing license, Free Sale Certificate, ISO 13485:2016, CE Certificate, DMF, PMF, Wholesale License, and Company Constitution.

2. Submit Application: Use Form MD14 on the CDSCO MD Online Portal.

3. Query Resolution: Respond to any clarifications raised by the authority.

4. License Grant: MD15 license is issued after compliance verification.

Note: Unlike manufacturing, no test license is required for imports. The process typically takes 5-6 months.

Import License Documents Required

• Manufacturing License of the foreign manufacturer
• Free Sale Certificate from the country of origin
• ISO 13485:2016 certificate
• CE Certificate (if applicable)
• Device Master File and Plant Master File
• Wholesale Drug License (for importers)
• Company Constitution

Timeline and Processing Duration for Class B Cold-Air Diagnostic Inhalation Systems

• MD13 Test License: 1.5 to 2 months
• Product Testing: 1 to 1.5 months (varies by laboratory backlog)
• Documentation Preparation: 2 to 3 weeks (can overlap with testing)
• MD5 License Application and Audit: 1.5 to 2 months

Total Estimated Time: Approximately 3 to 4 months from application to license grant for manufacturing.

For imports (MD15), expect around 5 to 6 months.

Government Fees and Costs

Manufacturing License (MD5) Fees:

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

Note: Fees must be paid online via the CDSCO portal.

Additional Costs:

• Product testing fees (varies by lab and device complexity)
• Audit fees payable to notified bodies (variable, generally ₹50,000 to ₹1,00,000)
• Documentation preparation and consultancy charges (if outsourced)

Common Challenges and Practical Solutions

• Delayed Testing Results: Plan submissions well in advance and choose CDSCO-recognized testing labs with shorter backlogs.

• Incomplete Documentation: Utilize detailed checklists and expert consultation to prepare robust Device and Plant Master Files.

• Audit Non-Conformance: Conduct internal pre-audit checks and ensure QMS compliance to avoid audit findings.

• Query Delays: Respond promptly and comprehensively to licensing authority queries to expedite processing.

Expert Consultation and Support

Navigating the CDSCO licensing process can be complex, especially for Class B devices like cold-air diagnostic inhalation systems. Our extensive experience has enabled over 500 manufacturers and importers to successfully secure their licenses by providing:

• End-to-end documentation support
• Coordination with CDSCO and notified bodies
• Pre-audit readiness assessments
• Strategic timelines management

Partnering with an experienced regulatory consultant not only accelerates your approval process but also minimizes costly compliance risks.

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm your device falls under Class B using the Medical Device Classification resource.

2. Register on CDSCO MD Online Portal: Create your account and familiarize yourself with the submission process at the CDSCO MD Online Portal.

3. Initiate Test License Application: Submit Form MD13 for your test license.

4. Engage a Notified Body Early: Select and communicate with a notified body from the official list to schedule your audit.

5. Prepare Complete Documentation: Leverage expert guides on Device Master Files and Plant Master Files to ensure compliance.

6. Plan Your Timelines: Allow 3 to 4 months for the entire manufacturing license process, factoring in testing, audits, and queries.

By following this structured path and leveraging expert support, manufacturers and importers of cold-air diagnostic inhalation systems can confidently navigate India's regulatory landscape and bring their life-enhancing respiratory devices to market efficiently.