CDSCO License for Resuscitator face mask, reusable
Medical Device Information
Intended Use
A flexible, form-shaped device that is placed over a patient's nose and mouth to direct ambient air, or medical oxygen (O2) and air, from a resuscitator to the upper airway and lungs. It is typically made of non- conductive sterilizable materials (e.g., silicone) that will create a gastight seal against the face. It will typically include a 15 mm and/or 22 mm connector and is available in a range of sizes (baby to adult). It will be directly attached to the resuscitator and held in place on the patient's face by the operator. This device is intended for use with a breathing resuscitator but may be used for the delivery of anaesthesia gases. This is a reusable device.
Comprehensive Guide to CDSCO Licensing for Reusable Resuscitator Face Masks (Class B Medical Device)
As a device manufacturer or importer aiming to enter the Indian market, securing the appropriate CDSCO license is a critical step. The reusable resuscitator face mask, classified as a Class B medical device under the Pediatrics and Neonatology category, requires a meticulous regulatory approach. With over 25 years of experience and having supported more than 500 companies in obtaining CDSCO licenses, we provide you with an in-depth, actionable guide tailored specifically for this device.
Understanding the Device and Its Regulatory Importance
The resuscitator face mask is a vital device designed to facilitate the delivery of ambient air or medical oxygen to patients, especially neonates and pediatrics. Its reusable nature means it must meet stringent quality and safety standards to ensure patient safety and device efficacy. Regulatory compliance with CDSCO ensures your device meets Indian standards and can be legally manufactured or imported.
CDSCO Regulatory Framework for Reusable Resuscitator Face Masks
The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India via a risk-based classification system. For Class B devices such as reusable resuscitator face masks, the manufacturing license is granted by the State Licensing Authority through the MD5 licensing route. Compliance with the Medical Device Rules, 2017 (amended from time to time) is mandatory for market authorization.
Risk Classification and License Requirements for Resuscitator Face Masks
- Risk Class: B (Low to moderate risk)
- Regulatory Pathway: MD5 License for manufacturing (Form MD3 application)
- Authority: State Licensing Authority
- Additional Requirements: Test license (Form MD13), product testing from CDSCO-approved labs, audit by notified bodies
For detailed classification, manufacturers can refer to the Medical Device Classification guide.
Manufacturing License Process (MD5) for Class B Devices
Test License Application (Form MD13): Initiate by applying for a test license to legally manufacture the device for testing purposes. This process takes approximately 1.5 to 2 months.
Product Testing: Conduct mandatory testing of the resuscitator face mask at a CDSCO-recognized testing laboratory. You can find the list of approved labs here.
Document Preparation: Compile all necessary documentation including Device Master File, Plant Master File, and Risk Management File.
License Application (Form MD3): Submit the manufacturing license application through the CDSCO MD Online Portal.
Auditing: Undergo an audit conducted by a notified body (refer to the list of notified bodies).
Query Resolution: Address any queries raised by the CDSCO or the notified body promptly to avoid delays.
License Grant: Upon successful audit and document verification, the MD5 manufacturing license is granted.
For more detailed insights, review our comprehensive MD5 License Guide.
Manufacturing License Documents Required for Resuscitator Face Masks
- Company Constitution Documents (e.g., Memorandum & Articles of Association)
- Proof of Ownership or Lease of Manufacturing Premises
- Technical Staff Qualifications and Experience Records
- Fire NOC and Pollution Control NOC
- Device Master File detailing design, materials, and manufacturing process (Device Master File Guide)
- Plant Master File describing manufacturing facility and equipment (Plant Master File Guide)
- Essential Principles Checklist ensuring compliance with Indian standards
- Risk Management File highlighting risk analysis and mitigation strategies (Risk Management Guide)
- Test Reports from CDSCO-approved laboratories
- Product Labels and Instructions for Use (IFU)
- Quality Management System (QMS) documents, preferably ISO 13485:2016 certification
Import License Process (MD15) for Resuscitator Face Masks
If you are importing the reusable resuscitator face mask instead of manufacturing locally, you must apply for an MD15 import license granted by the Central Licensing Authority.
- Application Form: MD14
- Documents: Manufacturing License from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device & Plant Master Files, Wholesale License, Company Constitution
- Fee Structure: For Class B devices, fees are approximately 1000 per product
- Timeline: Approximately 5-6 months
Submit your application via the CDSCO MD Online Portal. For a detailed step-by-step approach, consult our Import License Guide.
Timeline and Processing Duration
| Process Step | Duration |
|---|---|
| Test License (MD13) | 1.5 – 2 months |
| Product Testing | 2 – 3 weeks |
| Document Preparation | 2 – 3 weeks |
| MD5 License Application | 3 – 4 months total |
| Audit and Query Handling | Included in above |
Overall, obtaining an MD5 license for your reusable resuscitator face mask can take about 3 to 4 months post-test license issuance.
Government Fees and Costs
- Test License (MD13): Included in the overall process cost
- MD5 License Fees:
- Rs 5000 per application
- Rs 500 per product
- Testing Fees: Varies by laboratory; budget approx Rs 50,000 to Rs 1,00,000 depending on test scope
- Audit Fees: Paid to notified bodies directly, typically Rs 50,000 to Rs 1,50,000
Budgeting accurately for these costs upfront helps streamline your project planning.
Common Challenges and Solutions
- Delayed Audit Scheduling: Notified bodies have limited slots. Engage early and book audits promptly.
- Incomplete Documentation: Use checklists and templates to avoid back-and-forth with authorities.
- Test Report Rejections: Choose reputable CDSCO-approved labs and ensure test protocols align with Indian standards.
- Regulatory Changes: Keep abreast of amendments by regularly visiting the CDSCO portal.
Our practical tip: Maintain proactive communication with CDSCO officials and notified bodies to resolve queries swiftly.
Expert Consultation and Support
Navigating the CDSCO licensing process for Class B devices like reusable resuscitator face masks can be complex. Our team offers end-to-end support encompassing:
- Regulatory strategy and classification
- Document preparation and review
- Coordination with notified bodies and testing labs
- Application submission and follow-up
- Post-license compliance and renewals
Partnering with experienced consultants accelerates market entry while minimizing compliance risks.
Getting Started with Your CDSCO License Application
- Assess Your Product Classification: Confirm that your resuscitator face mask is Class B.
- Prepare Test License Application: Gather documents to apply for Form MD13 via the CDSCO MD Online Portal.
- Identify Testing Laboratory: Select an approved lab from the official list.
- Compile Required Documents: Use our Device and Plant Master File guides to prepare thorough submissions.
- Schedule Audit with Notified Body: Early scheduling avoids delays.
- Submit Manufacturing License Application (Form MD3): After successful testing.
By following these concrete steps and leveraging expert guidance, you can efficiently obtain your MD5 license and successfully launch your reusable resuscitator face mask in the Indian healthcare market.
For personalized assistance or a free regulatory consultation, contact us today and leverage our 25+ years of expertise in medical device licensing in India.
