CDSCO License for Rebreathing oxygen face mask

Introduction to Rebreathing Oxygen Face Mask and Regulatory Importance

The Rebreathing Oxygen Face Mask is a critical anesthesiology device used to deliver a precise mixture of air and oxygen (O2) to patients. Its flexible, form-shaped design ensures effective airway management, making it indispensable in clinical settings. Given its direct contact with patients’ respiratory pathways, regulatory oversight by the Central Drugs Standard Control Organization (CDSCO) ensures that these devices meet stringent safety and quality standards before entering the Indian market.

Navigating the CDSCO licensing process can be complex, especially for Class A devices such as the Rebreathing Oxygen Face Mask. With over 25 years of regulatory consulting experience and having assisted more than 500 companies, we provide you with clear, actionable insights to secure your manufacturing or import license efficiently.

CDSCO Regulatory Framework for Rebreathing Oxygen Face Mask

The CDSCO governs medical device regulation under the Medical Device Rules (MDR) 2017, notified via 29/Misc/03/2020-DC(177) on 12.07.2021 for this device category. Since the Rebreathing Oxygen Face Mask is classified as a Class A device (low risk), it falls under the purview of the State Licensing Authority for manufacturing licenses (MD5) and the Central Licensing Authority for import licenses (MD15).

Compliance with essential principles, quality management systems (such as ISO 13485:2016), and proper documentation is mandatory to ensure patient safety and regulatory adherence.

Risk Classification and License Requirements

• Device: Rebreathing Oxygen Face Mask
• Risk Class: A (Low Risk)
• License Type for Manufacturing: MD5 (Application Form MD3)
• Regulatory Authority: State Licensing Authority
• License Type for Import: MD15 (Application Form MD14)
• Regulatory Authority for Import: Central Licensing Authority

Class A devices require a focused yet thorough process involving test licenses, product testing, notified body audits, and document submissions.

Manufacturing License Process (MD5)

For manufacturers intending to produce Rebreathing Oxygen Face Masks in India, the MD5 license is mandatory. The entire process typically spans 3 to 4 months and includes the following steps:

1. Test License Application (Form MD13): Apply for a test license to enable product testing. This takes about 1.5 to 2 months.
2. Product Testing: Conduct testing at CDSCO-recognized laboratories. Testing ensures compliance with applicable standards.
3. Documentation Preparation: Compile all required documents, including Device Master File (DMF), Plant Master File (PMF), Risk Management File, and Essential Principles Checklist.
4. License Application (Form MD3): Submit the manufacturing license application through the CDSCO MD Online Portal.
5. Audit by Notified Body: Engage a notified body for audit of your manufacturing facility and quality systems. Refer to the list of notified bodies.
6. Resolution of Queries: Address any observations or queries raised by the licensing authority or the notified body.
7. Grant of Manufacturing License (Form MD5): Upon satisfactory compliance, the license is granted.

Practical Tip:

Starting the test license application early and coordinating with notified bodies can significantly reduce delays. Plan for concurrent document preparation and lab testing to optimize timelines.

Manufacturing License Documents Required

For your Rebreathing Oxygen Face Mask manufacturing license, ensure the following documents are complete and up-to-date:

• Company Constitution (e.g., incorporation certificate)
• Proof of Ownership or Lease of Manufacturing Premises
• Qualification and Experience Certificates of Technical Staff
• Fire No Objection Certificate (NOC)
• Pollution Control Board NOC
• Device Master File (DMF) – Detailed design, specifications, and manufacturing process. For guidance, see our Device Master File guide.
• Plant Master File (PMF) – Facility details, equipment, and quality control processes. Learn more from our Plant Master File guide.
• Essential Principles Checklist confirming compliance with MDR 2017
• Risk Management File documenting hazard analysis and mitigation strategies (Risk Management)
• Test Reports from CDSCO-recognized laboratories (Testing Laboratories)
• Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documentation (ISO 13485:2016 compliance)

Import License Process (MD15)

For companies seeking to import Rebreathing Oxygen Face Masks into India, the MD15 license is mandatory. This process is overseen by the Central Licensing Authority and typically takes 5 to 6 months.

Key steps include:

1. Document Preparation: Compile required documents as per CDSCO guidelines.
2. License Application (Form MD14): Submit your application through the CDSCO MD Online Portal.
3. Resolution of Queries: Address any clarifications requested by the authority.
4. Grant of Import License (Form MD15)

Notably, unlike manufacturing licenses, no test license or product testing is mandated for import licenses.

Import License Documents Required

To facilitate smooth processing, these documents should be ready:

• Valid Manufacturing License from the country of origin
• Free Sale Certificate or Certificate of Market Authorization
• ISO 13485:2016 Certificate
• CE Certificate (if applicable)
• Device Master File and Plant Master File
• Wholesale License (if applicable)
• Company Constitution documents

Timeline and Processing Duration

Government Fees and Costs

For the Rebreathing Oxygen Face Mask (Class A), the fee structure is as follows:

• MD5 Manufacturing License:
  • Application Fee: Rs. 5,000 per application
  • Product Fee: Rs. 500 per product
• MD15 Import License:
  • Site Fee: Approximately USD 1,000
  • Product Fee: USD 50 per product

These fees are payable via the CDSCO MD Online Portal as part of your application submission.

Common Challenges and Solutions

Challenge 1: Delays in Test License Approval

• Solution: Submit a thorough and complete application with all supporting documents. Engage early with CDSCO officials and testing labs.

Challenge 2: Product Testing Failures or Rejections

• Solution: Conduct pre-testing internally or through third-party labs to ensure compliance before official testing.

Challenge 3: Incomplete or Non-Compliant Documentation

• Solution: Follow comprehensive checklists such as those in our MD5 License Guide. Utilize expert consulting to prepare Device and Plant Master Files.

Challenge 4: Audit Non-Conformities by Notified Bodies

• Solution: Perform internal audits and gap analysis prior to notified body visits. Maintain robust QMS documentation.

Expert Consultation and Support

Having navigated CDSCO licensing complexities for over two decades, we understand the nuances of regulatory compliance for Class A devices like the Rebreathing Oxygen Face Mask. Our expert team offers:

• End-to-end application preparation
• Device and Plant Master File development
• Risk management implementation
• Coordination with notified bodies and testing laboratories
• Query resolution support

Our proven approach minimizes delays and maximizes your chances of first-time approval.

Getting Started with Your CDSCO License Application

To kickstart your CDSCO licensing journey for the Rebreathing Oxygen Face Mask:

1. Register on the CDSCO MD Online Portal: Create your account at the CDSCO MD Online Portal.
2. Assess Your Device Classification: Confirm your device as Class A and the corresponding licensing pathway.
3. Prepare Key Documentation: Begin compiling company credentials, Device Master File, Plant Master File, and Risk Management File.
4. Apply for Test License (MD13): Submit your test license application to initiate product testing.
5. Engage a Notified Body: Schedule your audit early by consulting the list of notified bodies.
6. Coordinate Product Testing: Book testing slots at CDSCO-approved laboratories.
7. Submit Manufacturing License Application (MD3): Once testing and audit are complete, apply for the MD5 license.

By following these steps and leveraging expert support, manufacturers can confidently enter the Indian market with their Rebreathing Oxygen Face Masks, ensuring patient safety and regulatory compliance.

For personalized consultation and a detailed roadmap tailored to your product, contact us today and benefit from our extensive regulatory expertise.