CDSCO License for Resuscitator face mask, single-use

Comprehensive Guide to Obtaining CDSCO License for Single-Use Resuscitator Face Mask (Class B Medical Device)

As a trusted regulatory consultancy with over 25 years of industry experience and a proven track record of assisting 500+ medical device manufacturers and importers, we provide you with expert guidance on obtaining the necessary CDSCO license for your single-use Resuscitator face mask. This device, classified as a Class B medical device due to its direct patient interface and moderate risk level, is critical in pediatric and neonatology care. Understanding and navigating the CDSCO regulatory framework effectively will help you enter the Indian market smoothly and compliantly.

CDSCO Regulatory Framework for Single-Use Resuscitator Face Mask

The Central Drugs Standard Control Organization (CDSCO) governs medical device registration and licensing in India. The Resuscitator face mask, given its intended use and risk profile, falls under Class B devices as per the Medical Device Rules, 2017. Compliance with CDSCO ensures that your product meets safety, quality, and performance standards required for market authorization.

Manufacturers of Class B devices must obtain the MD5 manufacturing license from the State Licensing Authority before marketing the device in India. Importers require the MD15 import license granted by the Central Licensing Authority.

For detailed classification criteria, we recommend reviewing the Medical Device Classification guide.

Risk Classification and License Requirements for Resuscitator Face Mask (Single-Use)

Device: Resuscitator face mask, single-use

Risk Class: B (Low to Moderate Risk)

License Type: MD5 Manufacturing License

Authority: State Licensing Authority

Typical Timeline: 3-4 months (including test license, testing, audit)

Fees: Rs 5000 per application + Rs 500 per product

The Class B classification mandates a thorough but streamlined approval process involving a test license, product testing in government-approved labs, documentation, and audit by a notified body.

Manufacturing License Process (MD5) for Class B Devices

1. Apply for Test License (Form MD13): This preliminary license allows you to conduct product testing critical for the final application. The test license processing typically takes 1.5 to 2 months.

2. Product Testing: Conduct testing at government-approved laboratories to verify compliance with essential principles and performance standards. Refer to the Testing Laboratories List to select an accredited lab.

3. Document Preparation: Compile all required documentation including Device Master File, Plant Master File, QMS documents, and risk management files.

4. Apply for Manufacturing License (Form MD3): Submit your application via the CDSCO MD Online Portal along with the test reports and supporting documents.

5. Audit by Notified Body: A notified body listed on the Notified Bodies List for MD5 Audit will conduct a comprehensive audit of your manufacturing facility and QMS.

6. Query Resolution: Address any queries or observations raised by the department or audit body promptly.

7. Grant of License: Upon satisfactory compliance, CDSCO will issue the MD5 license (Form MD5), allowing you to manufacture and market the device in India.

For an in-depth walkthrough, our MD5 License Guide is an excellent resource.

Manufacturing License Documents Required for Single-Use Resuscitator Face Mask

• Company Constitution Documents: Registration certificate, Memorandum & Articles of Association.
• Proof of Ownership or Lease Agreement: For the manufacturing premises.
• Technical Staff Details: Qualifications and experience of key personnel.
• Fire NOC and Pollution Control NOC: Compliance with local environmental and safety regulations.
• Device Master File (DMF): Comprehensive technical dossier detailing design, materials, and specifications. Check our Device Master File guide for preparation tips.
• Plant Master File (PMF): Documentation of manufacturing processes, equipment, and facility layout. Our Plant Master File guide can assist in compilation.
• Essential Principles Checklist: Declaration of compliance with Indian Medical Device Rules.
• Risk Management File: Documented risk assessment and mitigation strategies tailored for the resuscitator face mask. See our Risk Management guide for best practices.
• Test Reports: From government-approved laboratories confirming device safety and performance.
• Labels and Instructions for Use (IFU): Clear, compliant labeling and user instructions.
• Quality Management System (QMS) Documents: Evidence of adherence to ISO 13485:2016 or equivalent.

Attention to detail in compiling these documents significantly smoothens the audit and approval process.

Import License Process (MD15) for Resuscitator Face Mask

If you are an importer, obtaining an MD15 import license from the Central Licensing Authority is mandatory before marketing the device in India.

Process Highlights:

• No test license is required.
• Submit application on CDSCO MD Online Portal using Form MD14.
• Provide comprehensive documents including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE mark, Device and Plant Master Files, Wholesale License, and Company Constitution.
• Respond to any queries raised by CDSCO.
• License grant typically takes 5-6 months.

For detailed import licensing guidance, explore our Import License Guide.

Import License Documents Required for Single-Use Resuscitator Face Mask

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

These documents must be current and verifiable to facilitate smooth import licensing.

Timeline and Processing Duration

Planning ahead and allocating sufficient time for each stage, especially audit and testing, is critical for timely market entry.

Government Fees and Costs Breakdown

• MD5 Manufacturing License: Rs 5000 per application + Rs 500 per product
• MD13 Test License: Fees vary by state but typically included within MD5 process costs

Note: Additional costs include testing laboratory fees, notified body audit charges, and document preparation expenses.

A transparent budgeting plan helps avoid surprises and ensures uninterrupted regulatory progress.

Common Challenges and Practical Solutions

• Delayed Test Reports: Engage with accredited labs early and track testing progress regularly.
• Incomplete Documentation: Utilize checklists and expert review to ensure completeness.
• Audit Non-Compliance: Prepare your facility and QMS rigorously; conduct mock audits.
• Query Resolution Delays: Assign dedicated personnel to respond promptly to regulatory queries.

Our consultancy has successfully navigated these challenges for numerous clients, minimizing time to approval.

Expert Consultation and Support

With our extensive experience in CDSCO licensing, we offer tailored support including:

• End-to-end application preparation and submission
• Device and Plant Master File development
• Risk management implementation
• Coordination with testing labs and notified bodies
• Audit readiness and post-audit compliance

Engage with us to leverage our deep regulatory knowledge and expedite your product’s market authorization.

Getting Started with Your CDSCO License Application for Resuscitator Face Mask

1. Assess your device classification to confirm Class B status.
2. Register on the CDSCO MD Online Portal to initiate your application.
3. Prepare and submit your Test License application (Form MD13) to begin the testing phase.
4. Identify government-approved testing laboratories early to schedule testing promptly.
5. Compile all required documentation, leveraging our detailed guides for Device and Plant Master Files.
6. Engage a notified body from the approved list to prepare for the audit.
7. Prepare your manufacturing site and QMS as per audit requirements.
8. Submit your Manufacturing License application (Form MD3) upon successful testing.

Starting early and following a structured approach significantly improves your chances of timely approval.

For personalized assistance, contact our expert regulatory team today and transform your regulatory journey into a seamless experience.