CDSCO License for Oxygen Concentrator

Comprehensive Guide to CDSCO Licensing for Oxygen Concentrators (Class B Respiratory Devices)

Oxygen concentrators are vital respiratory medical devices designed to concentrate oxygen (O2) from ambient air and deliver it efficiently to patients requiring respiratory support. Given their critical role in healthcare, the Indian regulatory authority, the Central Drugs Standard Control Organization (CDSCO), mandates a thorough licensing process to ensure safety, quality, and efficacy before market entry.

With over 25 years of experience and having successfully guided 500+ companies through CDSCO licensing, we present a detailed, actionable guide tailored specifically for manufacturers and importers of Class B Oxygen Concentrators.

CDSCO Regulatory Framework for Oxygen Concentrators

As per the CDSCO notification (File No. 29/Misc/03/2020-DC(197), dated 6.8.2021), oxygen concentrators fall under the respiratory category and are classified as Class B medical devices. This classification is crucial because it determines the applicable licensing pathway and compliance requirements.

The CDSCO regulates such devices under the Medical Device Rules, 2017, ensuring that patient safety and product quality are maintained through stringent controls.

Risk Classification and License Requirements for Oxygen Concentrators

Oxygen concentrators are designated as Class B devices due to their moderate risk profile, meaning that while they are essential for patient care, their failure could cause minor to moderate harm.

For Class B devices, the required manufacturing license is the MD5 license, granted by the respective State Licensing Authority. This involves multiple stages, including test licensing, product testing, audits by notified bodies, and final license issuance.

You can verify your device classification and related regulations on our detailed Medical Device Classification guide.

Manufacturing License Process (MD5) for Oxygen Concentrators

The MD5 license process for Class B medical devices like oxygen concentrators typically spans 3 to 4 months, encompassing the following key steps:

1. Test License Application (Form MD13): Before full manufacturing licensing, manufacturers must obtain a test license valid for 6 months. This step takes approximately 1.5 to 2 months.

2. Product Testing: Samples of the oxygen concentrator must be tested at CDSCO-approved laboratories to verify compliance with Indian standards. Refer to the list of testing laboratories for approved facilities.

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

4. License Application Submission (Form MD3): Submit the manufacturing license application for MD5 through the official CDSCO MD Online Portal.

5. Audit by Notified Body: An audit by a notified body (selected from the CDSCO Notified Bodies List) is conducted to assess compliance with quality management systems and manufacturing practices.

6. Query Resolution: Address any queries or deficiencies raised by the CDSCO or the notified body promptly.

7. Grant of MD5 License: Once all conditions are met, the State Licensing Authority issues the manufacturing license in Form MD5.

Manufacturing License Documents Required for Oxygen Concentrators

A successful MD5 application requires meticulous preparation of the following:

• Company Constitution and Incorporation Documents
• Proof of Ownership or Lease of Manufacturing Premises
• Details and Qualification Certificates of Technical Staff
• Fire Safety NOC
• Pollution Control Board NOC
• Device Master File (DMF): Detailed design and manufacturing information (see our Device Master File guide)
• Plant Master File (PMF): Description of the manufacturing plant and equipment (Plant Master File guidance)
• Essential Principles Checklist confirming compliance with CDSCO requirements
• Risk Management File: Demonstrating hazard analysis and mitigation (refer to our Risk Management resource)
• Test Reports from government-approved laboratories
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) Documents including SOPs and CAPA procedures

Import License Process (MD15) for Oxygen Concentrators

If you are an importer of oxygen concentrators, the applicable license is the MD15 Import License, issued by the Central Licensing Authority. This process typically takes 5 to 6 months and includes:

• Preparing required documents (including manufacturing license of the manufacturer, Free Sale Certificate, ISO 13485:2016 certificate, CE Certificate, Device and Plant Master Files, and Wholesale Drug License)
• Submitting Form MD14 application through CDSCO MD Online Portal
• Addressing CDSCO queries
• License grant in Form MD15

For detailed guidance, check our Import License Guide.

Import License Documents Required

Key documents include:

• Valid Manufacturing License of the Manufacturer (MD5 or MD9)
• Free Sale Certificate from the country of origin
• ISO 13485:2016 Certification for Quality Management
• CE Certificate (if applicable)
• Device Master File and Plant Master File
• Wholesale Drug License (if applicable)
• Company Incorporation Documents

Timeline and Processing Duration

Note: The test license phase for MD5 takes about 1.5-2 months before the full license application.

Government Fees and Costs

For Oxygen Concentrator manufacturing (Class B devices), the government fees are as follows:

• MD5 License: Rs 5000 per application + Rs 500 per product

For import licenses (MD15), fees vary by device class and number of products; for Class B, typically:

• Rs 2000 per site + Rs 1000 per product

Budgeting for additional costs such as audits, testing fees, and consultancy is advisable.

Common Challenges and Solutions

• Incomplete Documentation: Many applicants face delays due to missing or insufficient documentation. We recommend rigorous internal audits before submission.

• Delays in Product Testing: Testing at approved labs can be time-consuming. Early sample submission and follow-up with labs accelerates the process.

• Audit Non-compliance: Notified body audits may raise non-conformities. Pre-audit readiness assessments can prevent this.

• Query Response Delays: Prompt and comprehensive replies to CDSCO queries help avoid prolonged processing.

• Understanding Regulatory Changes: Staying updated with notifications like the August 2021 classification of oxygen concentrators ensures compliance.

Expert Consultation and Support

Navigating CDSCO licensing for oxygen concentrators is complex but manageable with expert guidance. Our extensive experience enables us to offer:

• Strategic licensing roadmaps
• Document preparation and review
• Audit readiness support
• Liaison with CDSCO and notified bodies

Our clients consistently achieve timely approvals and market entry, avoiding common pitfalls.

Getting Started with Your CDSCO License Application

1. Assess your device classification: Confirm your oxygen concentrator as Class B on the CDSCO portal.

2. Gather and prepare documents: Use our Device Master File and Plant Master File guides to streamline documentation.

3. Apply for Test License (MD13): Initiate manufacturing licensing by submitting Form MD13 via the CDSCO MD Online Portal.

4. Coordinate product testing: Submit samples to CDSCO-approved labs early.

5. Plan for notified body audit: Select from the list of notified bodies and schedule your audit.

6. Submit final MD5 license application (Form MD3): After successful testing and audit.

7. Engage expert consultants: To ensure all steps comply with current regulations and to expedite approvals.

Embarking on the CDSCO licensing journey with a clear, stepwise plan and expert support will position your oxygen concentrator well for successful market access in India. Contact us for personalized assistance and compliance solutions tailored to your product and business needs.