CDSCO License for Helium/oxygen breathing gas mixer

Comprehensive Guide to CDSCO Licensing for Helium/Oxygen Breathing Gas Mixer (Class B Medical Device)

The Helium/Oxygen Breathing Gas Mixer is a critical device in anesthesiology, designed to accurately blend helium and oxygen gases to aid patients by enhancing oxygen flow to alveoli and reducing breathing effort. Its precision and safety are paramount, making regulatory approval by the Central Drugs Standard Control Organization (CDSCO) essential before market entry in India.

CDSCO Regulatory Framework for Helium/Oxygen Breathing Gas Mixers

Under the CDSCO regulatory framework, medical devices are classified into four risk categories (A to D). This device is classified as Class B (low to moderate risk), governed by the state licensing authority. Compliance with the Medical Device Rules, 2017, and adherence to the notified standards as per Notification 29/Misc/03/2020-DC(177) dated 12.07.2021, is mandatory.

Risk Classification and License Requirements for Class B Devices

Being a Class B device, the Helium/Oxygen Breathing Gas Mixer requires obtaining an MD5 manufacturing license (Form MD3) from the State Licensing Authority. This license ensures manufacturers meet quality, safety, and performance standards. Importers must secure an MD15 import license from the central authority.

Manufacturing License Process for Helium/Oxygen Breathing Gas Mixer (MD5 License)

At our consultancy, having facilitated over 500 successful CDSCO licenses, we recommend a structured approach:

1. Test License (Form MD13): Initiate by applying for a test license, which permits product testing in government-approved labs.
2. Product Testing: Conduct mandatory testing at notified laboratories to validate performance and safety.
3. Document Preparation: Compile all necessary documents including Device Master File and Plant Master File.
4. License Application (Form MD3): Submit the MD5 license application through the CDSCO MD Online Portal.
5. Audit by Notified Body: Coordinate audit from an accredited notified body; refer to the list of notified bodies for options.
6. Query Resolution: Address any queries or deficiencies raised by the department or notified body promptly.
7. Grant of License (Form MD5): Upon satisfactory compliance, the license will be granted.

Manufacturing License Documents Required for Helium/Oxygen Breathing Gas Mixer

Prepare and submit the following key documents:

• Company Constitution and Incorporation Certificate
• Proof of Ownership or Lease of Manufacturing Premises
• Technical Staff Qualifications and Experience
• Fire NOC and Pollution Control Board NOC
• Complete Device Master File detailing design, specifications, and intended use (Device Master File Guide)
• Plant Master File covering manufacturing processes and quality controls (Plant Master File Guide)
• Essential Principles Checklist demonstrating compliance with Indian Medical Device Rules
• Risk Management File outlining hazard analysis and mitigation (Risk Management)
• Product Test Reports from CDSCO-approved laboratories (Testing Laboratories)
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documentation, preferably ISO 13485:2016 certification

Import License Process for Helium/Oxygen Breathing Gas Mixer (MD15 License)

For importers, the process differs:

1. Document Preparation: Gather essential documents such as manufacturing license, Free Sale Certificate, ISO 13485:2016, CE Certificate, and detailed master files.
2. Application Submission: Apply using Form MD14 for the MD15 license on the CDSCO MD Online Portal.
3. Query Handling: Respond promptly to any department queries.
4. License Issuance: The central licensing authority grants the import license (Form MD15).

Import License Documents Required

• Valid Manufacturing License from the country of origin
• Free Sale Certificate or Certificate to Market
• ISO 13485:2016 Certification
• CE Certificate or Equivalent
• Detailed Device Master File and Plant Master File
• Wholesale License in India
• Company Constitution and Incorporation Certificate

Timeline and Processing Duration

For Manufacturing License (MD5): Approximately 3 to 4 months total.

• Test License: 1.5 to 2 months
• Product Testing: 15 to 30 days (can overlap with test license timeline)
• Application Preparation & Audit: 1 to 1.5 months
• Query Resolution: variable but typically 15 to 30 days

For Import License (MD15): Approximately 5 to 6 months, with no test license required.

Government Fees and Costs for Helium/Oxygen Breathing Gas Mixer

• MD5 License: Rs 5,000 per application + Rs 500 per product
• MD15 Import License (Class B): Rs 2,000 per site + Rs 1,000 per product

Budgeting for notified body audits, product testing fees (variable by lab), and consultancy support is also essential.

Common Challenges and Solutions

• Delayed Testing Results: Select CDSCO-approved laboratories with efficient turnaround times. Early booking helps.
• Incomplete Documentation: Use our comprehensive checklists and templates to avoid omissions.
• Audit Non-Compliance: Conduct pre-audit internal assessments; engage experienced notified bodies listed on the Notified Bodies List.
• Query Delays: Assign dedicated personnel for prompt responses.

Expert Consultation and Support

With over 25 years of regulatory consulting experience and assisting 500+ companies, we offer end-to-end support:

• Preparing detailed Device and Plant Master Files
• Coordinating product testing and audit scheduling
• Liaising with CDSCO officers and notified bodies
• Tailored risk management implementation

Our proven track record minimizes delays and accelerates market entry.

Getting Started with Your CDSCO License Application for Helium/Oxygen Breathing Gas Mixer

1. Assess Your Device Classification and confirm it is Class B.
2. Register on the CDSCO MD Online Portal to set up your applicant profile.
3. Initiate the Test License Application (Form MD13) to start product testing.
4. Gather and Prepare Required Documentation using our detailed checklists.
5. Engage with a Notified Body early to schedule your audit.
6. Submit the MD5 License Application once testing and documentation are complete.

Starting early and maintaining close communication with CDSCO and notified bodies is key. For personalized guidance, connect with our expert team to streamline your regulatory journey for the Helium/Oxygen Breathing Gas Mixer in India.

Embark on your CDSCO licensing process confidently with our industry-leading expertise and ensure your device reaches patients safely and compliantly.