CDSCO License for Steam inhaler

Introduction to Steam Inhaler and Regulatory Importance

Steam inhalers are electrically-powered, hand-held medical devices designed to deliver therapeutic steam for relieving congestion and pressure tied to upper respiratory disorders. As a Class A respiratory device under CDSCO classification, steam inhalers are considered low-risk but require strict regulatory compliance to ensure safety and effectiveness for consumers in India.

With over 25 years of experience and having guided 500+ companies, we understand the nuances of securing CDSCO licenses for devices like steam inhalers. Proper registration is not only a legal mandate but also a mark of quality assurance that builds trust in Indian and global markets.

CDSCO Regulatory Framework for Steam Inhalers

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices under the Medical Device Rules, 2017. Steam inhalers fall under Class A, the lowest risk category, governed primarily by the State Licensing Authority.

The regulatory workflow includes getting a Test License (Form MD13), product testing from government-approved labs, documentation, an audit by a notified body, and finally, grant of the Manufacturing License (MD5) via Form MD3 submission on the CDSCO MD Online Portal.

Risk Classification and License Requirements for Steam Inhalers

• Device: Steam Inhaler
• Risk Class: A (Low Risk)
• Regulatory Body: State Licensing Authority
• License Type: MD5 (Manufacturing License)

As a Class A device, the MD5 license is mandatory before manufacturing or marketing. This classification means a relatively straightforward process, but adherence to documentation and testing requirements is crucial.

For detailed classification references, visit our Medical Device Classification guide.

Manufacturing License Process (MD5) for Steam Inhalers

The MD5 license process typically takes 3-4 months and involves these key steps:

1. Apply for Test License (Form MD13): Enables initial product testing; takes approximately 1.5-2 months.
2. Product Testing: Conducted at government-approved testing laboratories, ensures compliance with essential principles.
3. Document Preparation: Compile Device Master File, Plant Master File, Risk Management file, Essential Principles Checklist, and other required documents.
4. Submit Manufacturing License Application (Form MD3): Via the CDSCO MD Online Portal.
5. Audit by Notified Body: Choose from the list of notified bodies for a mandatory audit of manufacturing facilities and QMS.
6. Query Resolution: Address any queries raised by the licensing authority or notified body promptly.
7. Grant of MD5 License: Issued on Form MD5 post successful audit and documentation review.

Manufacturing License Documents Required for Steam Inhalers

Manufacturers must submit a comprehensive set of documents, including:

• Company Constitution Documents: Incorporation certificate, partnership deed, etc.
• Proof of Ownership or Lease of Manufacturing Premises
• Technical Staff Qualification & Experience Certificates
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF): Detailed device specifications, design, manufacturing process. Refer to our Device Master File guide for preparation tips.
• Plant Master File (PMF): Details of manufacturing site, equipment, and process controls. Learn more from our Plant Master File guide.
• Essential Principles Checklist: Compliance matrix with Indian Medical Device Rules.
• Risk Management File: Hazard analysis and risk mitigation strategies following ISO 14971. Our Risk Management resource can assist.
• Test Reports: From government-approved labs validating safety and performance.
• Labels and Instructions for Use (IFU): Ensure they meet regulatory language and content requirements.
• Quality Management System (QMS) Documents: Procedures and records evidencing compliance with ISO 13485 or equivalent.

Import License Process for Steam Inhalers

For importers, the relevant license is the MD15 license granted by the Central Licensing Authority. Given the steam inhaler is Class A, the import license fees are modest but the process is lengthier (~5-6 months).

The process involves:

• Preparing documents including the manufacturer’s MD5 license, Free Sale Certificate, ISO 13485 certification, CE Certificate, DMF, PMF, and wholesale license.
• Applying via the CDSCO MD Online Portal on Form MD14.
• Responding to any queries raised by CDSCO.
• License grant on Form MD15.

Refer to our Import License guide for detailed insights.

Import License Documents Required

• Valid Manufacturing License (MD5) from the country of origin
• Free Sale Certificate from recognized authority
• ISO 13485:2016 certification
• CE Certificate or equivalent
• Device Master File & Plant Master File
• Wholesale Drug License (if applicable)
• Company Constitution and address proof

Timeline and Processing Duration

Timelines may vary based on application completeness and audit scheduling.

Government Fees and Costs

• Test License (MD13): Included in overall fees
• MD5 Manufacturing License Fees: Rs 5,000 per application + Rs 500 per product (steam inhaler considered a single product)
• Testing Fees: Variable depending on tests required, typically Rs 20,000-50,000
• Audit Fees: Paid directly to notified bodies, ranging from Rs 50,000 to Rs 1,00,000 depending on scope

Budgeting these costs upfront helps avoid surprises.

Common Challenges and Solutions

• Incomplete Documentation: Prepare documents as per detailed checklists; leverage expert templates for DMF and PMF.
• Delays in Testing: Schedule tests well in advance with notified labs listed on the CDSCO Testing Laboratories page.
• Audit Non-Compliance: Conduct pre-audit internal assessments and ensure QMS is robust.
• Query Management: Respond promptly and clearly to regulatory queries; maintain open communication channels.

Our experience suggests manufacturers who invest time in pre-submission audits and robust documentation face fewer hurdles.

Expert Consultation and Support

With over 25 years in medical device regulatory consulting, we offer end-to-end support for steam inhaler manufacturers—from documentation drafting to audit readiness and license application submission.

We help you navigate complexities, reduce timelines, and avoid common pitfalls, ensuring your product reaches the Indian market without regulatory delays.

Getting Started with Your CDSCO License Application for Steam Inhalers

1. Assess Device Classification: Confirm Class A status and regulatory pathway.
2. Engage a Testing Laboratory: Book your testing slot early.
3. Prepare Device and Plant Master Files: Follow best practices for thorough documentation.
4. Apply for Test License (MD13): Submit via the CDSCO MD Online Portal to initiate testing.
5. Select a Notified Body: Coordinate with one from the official list of notified bodies for your audit.
6. Compile Complete Application: Ensure all documents and fees are ready.
7. Submit MD5 License Application: Via the online portal.
8. Prepare for Audit and Query Resolution: Stay responsive and organized.

By following these practical steps and leveraging experienced guidance, manufacturers can efficiently obtain their CDSCO MD5 license and confidently launch their steam inhaler products in India.

For further personalized assistance, feel free to contact our regulatory experts who have successfully supported hundreds of medical device companies in India.