CDSCO License for Therapeutic air ionizer

Comprehensive Guide to CDSCO Licensing for Therapeutic Air Ionizer (Class A Medical Device)

Entering the Indian medical device market with a Therapeutic Air Ionizer, a Class A respiratory device, requires a clear understanding of the CDSCO (Central Drugs Standard Control Organization) regulatory framework. With over 25 years of experience assisting 500+ companies, we provide you with an expert roadmap to secure your manufacturing or import license efficiently and compliantly.

Understanding the Therapeutic Air Ionizer and Regulatory Importance

Therapeutic Air Ionizers produce biologically-active, negatively charged oxygen ions pulsed at selected frequencies, aimed at therapeutic benefits by absorption through the lungs into the bloodstream. As a Class A device under the respiratory category, it is considered low risk but still requires adherence to strict regulatory protocols to ensure safety and efficacy.

The device is notified under File No. 29/Misc/03/2020-DC(197) dated 6.8.2021, making compliance with CDSCO regulations mandatory before manufacturing or import.

CDSCO Regulatory Framework for Therapeutic Air Ionizer

The CDSCO classifies medical devices into four risk classes (A, B, C, D), with Class A being the lowest risk. For Therapeutic Air Ionizers, the licensing process involves the State Licensing Authority and requires an MD5 manufacturing license if you intend local production, or an MD15 import license if you plan to bring the device into India.

Risk Classification and License Requirements

• Device Name: Therapeutic Air Ionizer
• Risk Class: A (Low risk)
• Regulatory License: MD5 Manufacturing License (Form MD3) for domestic manufacturing
• Authority: State Licensing Authority

This classification means the device is subject to a streamlined but thorough licensing process, including test licensing, product testing, documentation, and audits.

Manufacturing License Process for Therapeutic Air Ionizer (MD5)

The process to obtain an MD5 license for a Class A device typically spans 3 to 4 months, comprising multiple critical steps:

1. Test License Application: Apply for a test license on Form MD13, taking approximately 1.5 to 2 months.
2. Product Testing: Submit samples to CDSCO-approved testing laboratories for compliance verification.
3. Document Preparation: Compile required documentation including Device Master File and Plant Master File.
4. Manufacturing License Application: Submit Form MD3 for the MD5 license.
5. Audit: Undergo an audit conducted by a notified body.
6. Queries and Clarifications: Respond to any queries raised by CDSCO or auditors.
7. License Grant: Upon successful evaluation, the MD5 license is granted on Form MD5.

You must submit your application through the CDSCO MD Online Portal for digital processing.

Manufacturing License Documents Required

For a Therapeutic Air Ionizer, the documentation must be thorough and precise, including:

• Company Constitution and Registration Certificates
• Proof of Ownership or Lease of Manufacturing Premises
• Technical Staff Qualification and Experience Documents
• Fire Department No-Objection Certificate (NOC)
• Pollution Control Board NOC
• Device Master File (DMF): Detailed design, materials, and performance data. Our comprehensive Device Master File guide can help you prepare this critical dossier.
• Plant Master File (PMF): Manufacturing process, quality control, and facility details. Refer to our Plant Master File guide for assistance.
• Essential Principles Checklist confirming compliance with Indian Medical Device Rules
• Risk Management File documenting hazard analysis and mitigation strategies
• Test Reports from CDSCO-approved labs
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) Documents, typically ISO 13485 compliant

Import License Process (MD15) for Therapeutic Air Ionizer

If you plan to import the Therapeutic Air Ionizer, the MD15 license is mandatory and overseen by the Central Licensing Authority. The process generally takes 5 to 6 months and includes:

• Preparation of application documentation including manufacturing license from the country of origin
• Submission of Form MD14 for the MD15 import license
• Review and queries resolution
• Grant of license on Form MD15

Unlike manufacturing, import licensing does not require a test license or audit.

Import License Documents Required

• Valid Manufacturing License from the country of origin
• Free Sale Certificate
• ISO 13485:2016 Certification
• CE Certificate or equivalent
• Device Master File and Plant Master File
• Wholesale Drug License
• Company Constitution and Registration

Fees vary based on risk class and product count; see the Government Fees section below.

Timeline and Processing Duration

Timelines may vary based on document completeness and audit scheduling.

Government Fees and Costs

For a Class A device like the Therapeutic Air Ionizer, the fee structure is as follows:

• MD5 Manufacturing License: Rs 5,000 per application + Rs 500 per product
• MD13 Test License: Included within MD5 process
• MD15 Import License: $1000 per site +$50 per product (if applicable)

Budgeting for additional costs such as notified body audits and third-party testing is essential.

Common Challenges and Solutions

Challenge 1: Delays due to incomplete or inconsistent documentation

Solution: Utilize detailed checklists and consult with experts to ensure your Device Master File and Plant Master File are comprehensive and aligned with CDSCO expectations.

Challenge 2: Scheduling audits with notified bodies

Solution: Early coordination with notified bodies listed on the CDSCO Notified Bodies List can prevent bottlenecks.

Challenge 3: Product testing failures or delays

Solution: Choose accredited testing labs from the CDSCO Testing Laboratories list and conduct pre-tests internally to mitigate risks.

Challenge 4: Responding to CDSCO queries

Solution: Prepare prompt and precise responses, supported with relevant documentation and expert advice.

Expert Consultation and Support

Navigating CDSCO licensing can be complex, especially with evolving regulations and device-specific nuances. Our team, with extensive experience in regulatory consulting, helps you:

• Prepare and review all documentation
• Coordinate with notified bodies and testing labs
• Manage submission timelines and responses
• Ensure compliance with Indian Medical Device Rules 2017 and subsequent amendments

Getting Started with Your CDSCO License Application for Therapeutic Air Ionizer

1. Verify Device Classification: Confirm your Therapeutic Air Ionizer is Class A under the latest CDSCO guidelines. Use tools like the Medical Device Classification resource for clarity.
2. Register on the CDSCO MD Online Portal: Set up your company account at CDSCO MD Online Portal.
3. Prepare Device and Plant Master Files: Follow our detailed guides to assemble these critical documents.
4. Apply for Test License (MD13): Initiate product testing and quality verification.
5. Arrange Product Testing: Coordinate with CDSCO-approved labs for timely testing.
6. Submit Manufacturing License Application (MD5): Once testing is complete and documentation ready, submit Form MD3.
7. Schedule Audit: Coordinate with a notified body early to avoid delays.
8. Respond to Queries: Maintain close communication with CDSCO and auditors.

By following these actionable steps and leveraging expert support, you can efficiently obtain your CDSCO license and confidently bring your Therapeutic Air Ionizer to the Indian market.

For detailed assistance, consult our MD5 License Guide or contact our regulatory experts for personalized support.