CDSCO License for Non-heated respiratory humidifier

Comprehensive Guide to CDSCO Licensing for Non-Heated Respiratory Humidifiers (Class B Medical Device)

As seasoned regulatory consultants with over 25 years of experience and having successfully supported 500+ companies in navigating the CDSCO licensing landscape, we understand the critical nuances involved in bringing a medical device like the Non-heated respiratory humidifier to the Indian market. This device, classified as Risk Class B under anesthesiology, plays an essential role in preventing airway dryness during oxygen therapy by adding water vapor to dry oxygen gas.

In this guide, we walk you through the entire CDSCO licensing process tailored specifically to this device type, covering regulatory requirements, documentation, timelines, fees, and practical tips to streamline your approval journey.

CDSCO Regulatory Framework for Non-Heated Respiratory Humidifiers

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices under the Medical Device Rules (MDR) 2017. The Non-heated respiratory humidifier is notified under the medical device notification number 29/Misc/03/2020-DC(177) dated 12.07.2021 and falls under Class B (low moderate risk) category.

This classification mandates obtaining the MD5 manufacturing license granted by the State Licensing Authority before you can legally manufacture and market the device in India.

You can initiate your license application via the CDSCO MD Online Portal, a centralized system designed to facilitate smooth submissions and tracking.

Risk Classification and License Requirements for Class B Devices

Class B devices are considered low to moderate risk. According to CDSCO:

• Manufacturing License: MD5 License (Application Form MD3) obtained from the State Licensing Authority.
• Test License: MD13 Test License is mandatory before the manufacturing license application to facilitate product testing.
• Audit: Conducted by a notified body listed on the Notified Bodies List.

This device’s classification means your licensing process will involve both technical product testing and a facility audit focused on compliance with the Essential Principles of Safety and Performance.

Manufacturing License Process for Non-Heated Respiratory Humidifiers (MD5 License)

The MD5 licensing journey typically unfolds in the following stages:

1. Apply for MD13 Test License: Submit application via the CDSCO portal for the test license. This license allows you to send samples for mandatory product testing.
2. Product Testing: Get your humidifier tested in accredited government-approved laboratories listed in the Testing Laboratories Directory. Testing ensures compliance with safety and performance standards.
3. Document Preparation: Compile all required documentation including Device Master File, Plant Master File, Risk Management File, and QMS documents.
4. Submit Manufacturing License Application (Form MD3): Apply for the MD5 license through the CDSCO online portal.
5. Facility Audit: Once the documents are accepted, a notified body performs an audit of your manufacturing facility and QMS.
6. Respond to Queries: Address any clarifications or observations from the audit or CDSCO.
7. Grant of License: If compliant, CDSCO grants the MD5 license on Form MD5.

For detailed guidance on MD5 licensing, consult our MD5 License Guide.

Manufacturing License Documents Required for Non-Heated Respiratory Humidifiers

To ensure a smooth licensing process, prepare the following documentation meticulously:

• Company Constitution Documents: Incorporation certificate, partnership deed, or equivalent proof.
• Proof of Premises Ownership/Lease Agreement: Confirming your manufacturing location.
• Technical Staff Details: Qualification and experience certificates of key personnel.
• Fire NOC and Pollution Control Board NOC: Compliance with local statutory requirements.
• Device Master File (DMF): Detailed description of the device design, manufacturing process, and specifications. Our comprehensive Device Master File guide can assist in preparation.
• Plant Master File (PMF): Detailed overview of your manufacturing facility and quality systems. Learn to create a compliant PMF here.
• Essential Principles Checklist: Declaration of compliance with essential safety and performance principles.
• Risk Management File: Documentation of risk analysis and mitigation, crucial for Class B devices. Refer to our Risk Management guide.
• Test Reports: From government-approved testing laboratories.
• Labels and Instructions for Use (IFU): Device labeling and user manuals compliant with CDSCO guidelines.
• Quality Management System Documents: Including SOPs and certifications (ISO 13485:2016 preferred).

Import License Process for Non-Heated Respiratory Humidifiers (MD15 License)

If you are an importer rather than a manufacturer, the import license (MD15) must be obtained from the Central Licensing Authority. The process involves:

• Comprehensive document preparation including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certificate, CE certificate, Device Master File, Plant Master File, and Wholesale License.
• Submit application on the CDSCO MD Online Portal.
• Respond to any queries raised during the review.
• Upon satisfaction, CDSCO issues the MD15 Import License.

For detailed guidelines, see our Import License Guide.

Import License Documents Required

Key documents required for MD15 license include:

• Valid Manufacturing License of the device from the country of origin.
• Free Sale Certificate.
• ISO 13485:2016 certification.
• CE Certificate or equivalent.
• Device Master File and Plant Master File.
• Wholesale License.
• Company constitution and address proof.

Timeline and Processing Duration

The MD5 licensing process for Class B devices like the Non-heated respiratory humidifier typically takes 3-4 months end-to-end, broken down as:

• MD13 Test License: 1.5 to 2 months
• Product Testing: 3 to 4 weeks (depending on lab availability)
• Document Preparation and Submission: 2 to 3 weeks
• Facility Audit and Review: 3 to 4 weeks
• Query Resolution and Final Approval: 2 to 3 weeks

Planning and adhering to these timelines is essential to prevent delays. Early engagement with notified bodies and testing labs can expedite the process.

Government Fees and Costs

The fee structure for MD5 license application is as follows:

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

Additional costs to budget for:

• Testing charges at government-approved labs (varies by test scope)
• Notified body audit fees (varies by agency)
• Consultancy and documentation preparation (if outsourced)

Investing in professional regulatory support can often save time and costs by avoiding common pitfalls.

Common Challenges and Practical Solutions

Challenge 1: Delays in Product Testing

• Solution: Pre-book slots with notified government labs and prepare samples meticulously to avoid rejections.

Challenge 2: Incomplete Documentation

• Solution: Use comprehensive checklists and templates for Device Master File and Risk Management File. Our guides provide actionable templates.

Challenge 3: Audit Non-Compliance

• Solution: Perform internal mock audits and address gaps in QMS before notified body visits.

Challenge 4: Query Management

• Solution: Respond promptly and comprehensively to CDSCO and notified body queries with supporting evidence.

Expert Consultation and Support

Navigating CDSCO licensing requires detailed knowledge of regulatory nuances and document standards. As trusted consultants, we have:

• Guided over 500 medical device companies through successful MD5 license approvals.
• Assisted in preparation of Device and Plant Master Files tailored for Indian regulatory expectations.
• Coordinated with notified bodies and government labs to streamline audits and testing.

Engaging expert consultants early in your licensing journey can reduce timelines and enhance compliance.

Getting Started with Your CDSCO License Application for Non-Heated Respiratory Humidifiers

1. Assess your device classification (Class B) and confirm the need for MD5 license.
2. Register on the CDSCO MD Online Portal to access application forms and track submissions.
3. Apply for the MD13 Test License to initiate product testing.
4. Prepare your Device Master File, Plant Master File, and Risk Management File using standardized templates.
5. Engage a notified body early for pre-audit consultations.
6. Schedule and complete product testing at government-approved labs.
7. Submit your MD5 manufacturing license application (Form MD3) with all required documents.
8. Prepare for and undergo the manufacturing site audit.
9. Respond effectively to any queries from CDSCO or notified bodies.
10. Receive your license and initiate manufacturing and marketing in India legally.

By following these actionable steps and leveraging expert guidance, manufacturers of Non-heated respiratory humidifiers can confidently enter the Indian medical device market with full regulatory compliance.

For further personalized assistance, feel free to reach out to our regulatory consulting team specializing in CDSCO licensing for anesthesiology devices.