CDSCO License for Heated respiratory humidifier
Medical Device Information
Intended Use
A device designed to heat and humidify air/oxygen inspired by a patient to help maintain the mucous membranes of the respiratory tract typically during periods of prolonged respiratory support/therapy.
Comprehensive CDSCO Licensing Guide for Heated Respiratory Humidifiers (Class B)
As specialists with over 25 years of experience assisting more than 500 companies successfully navigate the Indian regulatory landscape, we understand the nuances of obtaining CDSCO licenses for medical devices. The Heated Respiratory Humidifier, a Class B respiratory device designed to provide heated and humidified air or oxygen for patients undergoing respiratory therapy, is subject to specific regulatory requirements under the CDSCO framework.
Understanding the Device and Its Regulatory Importance
Heated Respiratory Humidifiers play a critical role in maintaining the mucous membranes of the respiratory tract, especially for patients requiring prolonged respiratory support. Given their direct interaction with patient respiratory systems, ensuring their safety, efficacy, and quality is paramount. The Central Drugs Standard Control Organization (CDSCO) governs the licensing of such devices in India, ensuring compliance with national and international standards.
CDSCO Regulatory Framework for Heated Respiratory Humidifiers
Under the Medical Device Rules (MDR) 2017, amended periodically, Heated Respiratory Humidifiers are classified as Class B medical devices due to moderate risk. This classification determines the licensing authority, documentation, testing, and audit requirements.
Risk Classification and License Requirements
- Device: Heated Respiratory Humidifier
- Risk Class: B (Moderate Risk)
- Regulatory Category: Respiratory Device
- Applicable License: MD5 Manufacturing License (Form MD3) granted by the State Licensing Authority
For this device, manufacturers must first obtain a Test License (Form MD13), get products tested at government-approved laboratories, prepare all necessary documentation, undergo an audit by a notified body, and finally apply for the MD5 license.
Manufacturing License Process for Heated Respiratory Humidifiers (MD5 License)
The MD5 license process is specifically tailored for Class A and B devices and typically takes 3 to 4 months. Here’s a step-by-step overview:
Test License Application (Form MD13): Apply for a test license which takes approximately 1.5 to 2 months. This permits you to manufacture the device in limited quantities for testing purposes.
Product Testing: Conduct testing at CDSCO-approved laboratories to verify compliance with essential principles and standards. You can refer to the list of testing laboratories for appropriate facilities.
Document Preparation: Compile all required documents, including Device Master File and Plant Master File.
Application Submission: Submit the MD5 license application (Form MD3) via the CDSCO MD Online Portal.
Audit by Notified Body: A notified body from the official list of notified bodies will conduct an audit of your manufacturing site and quality systems.
Query Resolution: Address any queries raised by the licensing authority or notified body promptly.
License Grant: Upon satisfactory compliance, the State Licensing Authority will issue the MD5 manufacturing license.
Manufacturing License Documents Required
For the Heated Respiratory Humidifier Class B device, the following documentation is mandatory:
- Company Constitution and Incorporation Certificate
- Proof of Ownership or Lease of Manufacturing Premises
- Technical Staff Qualification and Experience Details
- Fire NOC and Pollution Control NOC
- Device Master File (DMF) detailing device specifications and design (Device Master File guide)
- Plant Master File outlining manufacturing processes and controls (Plant Master File guide)
- Essential Principles Checklist demonstrating conformity to safety and performance requirements
- Risk Management File documenting identified risks and mitigation strategies (Risk Management overview)
- Test Reports from CDSCO-approved labs
- Product Labels and Instructions for Use (IFU)
- Quality Management System (QMS) documents, typically ISO 13485:2016 compliance
Import License Process for Heated Respiratory Humidifiers (MD15 License)
If you are an importer seeking to market Heated Respiratory Humidifiers in India, an MD15 import license from the Central Licensing Authority is required. The process generally spans 5 to 6 months and involves:
- Preparation of all import-related documentation
- Submission of the application on the CDSCO MD Online Portal
- Resolution of departmental queries
- Grant of the import license (Form MD15)
Required documents include:
- Valid Manufacturing License from the country of origin
- Free Sale Certificate
- ISO 13485:2016 Certification
- CE Certificate (if applicable)
- Device Master and Plant Master Files
- Wholesale Drug License (if applicable)
- Company Constitution
Timeline and Processing Duration
| Process Step | Duration |
|---|---|
| Test License (MD13) | 1.5 - 2 months |
| Product Testing | 1 - 1.5 months |
| Document Preparation | 2 - 3 weeks |
| Application Submission & Audit | 1 - 1.5 months |
| Query Resolution & Final License | 2 - 3 weeks |
Total Estimated Time: Approximately 3 to 4 months for MD5 Manufacturing License.
Government Fees and Costs
- Test License Fee (MD13): Approximately Rs. 5,000
- MD5 Manufacturing License: Rs. 5,000 per application + Rs. 500 per product
- Product Testing Costs: Variable depending on the number of tests and lab charges
- Audit Fees: Typically borne by the applicant, varies per notified body
Common Challenges and Solutions
- Delayed Test Reports: Coordinate early with accredited testing labs to avoid bottlenecks.
- Incomplete Documentation: Use checklists and expert reviews to ensure all required documents are complete and accurate.
- Audit Non-conformities: Prepare your quality systems and manufacturing processes in advance, aligning with notified body requirements.
- Query Backlogs: Respond promptly and comprehensively to regulatory queries to prevent unnecessary delays.
Our experience has shown that proactive planning and adherence to timelines significantly improve licensing success.
Expert Consultation and Support
Navigating the CDSCO licensing process can be complex, especially for Class B respiratory devices like Heated Respiratory Humidifiers. Our consultancy has successfully guided over 500 companies through test license acquisition, product testing, documentation, and audits. We offer tailored support including:
- Preparing and reviewing Device and Plant Master Files
- Coordinating with notified bodies and testing labs
- Drafting risk management and essential principles checklists
- Managing application submissions and regulatory communications
Getting Started with Your CDSCO License Application
To initiate your licensing process for the Heated Respiratory Humidifier:
- Register your company and device on the CDSCO MD Online Portal.
- Begin compiling your Device and Plant Master Files using our comprehensive guides.
- Apply for the Test License (Form MD13) to commence product testing.
- Schedule testing with a CDSCO-approved laboratory.
- Prepare your Quality Management System documents in compliance with ISO 13485:2016.
- Engage with a notified body early to plan your audit.
Taking these proactive steps ensures a swift and smooth MD5 license grant, enabling you to bring your Heated Respiratory Humidifier to the Indian market confidently and compliantly.
For personalized assistance, reach out to our expert regulatory consultants who can provide end-to-end support tailored to your device and business needs.
