CDSCO License for ENT chair, electric

Comprehensive Guide to CDSCO Licensing for ENT Chair, Electric (Class A Medical Device)

At our consulting firm, with over 25 years of dedicated experience and having successfully assisted 500+ companies, we understand the critical importance of securing timely and compliant CDSCO licenses for medical devices like the ENT chair, electric. This device, designed to support patients in a seated position with electrical adjustments for ENT examinations and minor surgeries, falls under Class A risk category as per CDSCO Notification 29/Misc/03/2020-DC(196) dated 06.08.2021.

Navigating the regulatory landscape for such devices requires detailed knowledge of the CDSCO framework, documentation, and procedural steps. Here, we provide an exhaustive, step-by-step guide to help manufacturers and importers secure the necessary licenses efficiently.

CDSCO Regulatory Framework for ENT Chair, Electric

The Central Drugs Standard Control Organization (CDSCO) governs medical device regulation in India. Post the notification dated 06.08.2021, the ENT chair, electric is classified as a Class A device — considered low risk. This requires compliance with the Medical Device Rules 2017 and adherence to quality, safety, and performance standards.

Class A devices are regulated primarily by State Licensing Authorities, streamlining the process but requiring strict adherence to documentation and audit requirements.

Risk Classification and License Requirements for ENT Chair, Electric

• Device: ENT Chair, Electric
• Risk Class: A (Low Risk)
• Regulatory License: MD5 Manufacturing License
• Application Form: MD3
• Licensing Authority: State Licensing Authority

The ENT chair's classification as Class A means it qualifies for the MD5 license, which is comparatively faster and less costly than higher-risk classes. Nonetheless, compliance with technical and quality standards remains stringent.

Manufacturing License Process (MD5) for ENT Chair, Electric

1. Test License Application (Form MD13): Before obtaining a manufacturing license, manufacturers must secure a test license. This allows for product testing and validation. The test license process typically takes 1.5 to 2 months.

2. Product Testing: The ENT chair must be tested at a CDSCO-approved government testing laboratory (see testing laboratories) to verify compliance with essential principles and safety requirements.

3. Documentation Preparation: Prepare comprehensive documentation including technical files, quality management system (QMS) records, risk management files, and device master files.

4. Application Submission: Submit the MD5 license application via the CDSCO MD Online Portal using Form MD3.

5. Audit by Notified Body: An audit by an approved notified body (refer to the list of notified bodies) is mandatory to assess manufacturing compliance and QMS.

6. Queries Resolution: Address any queries or observations raised by the licensing authority or notified body promptly.

7. License Grant: Upon satisfactory review and audit, the MD5 license is granted, authorizing manufacturing.

Manufacturing License Documents Required for ENT Chair, Electric

To ensure your application is complete and reduces delays, prepare the following:

• Company Constitution Documents (Incorporation Certificate, PAN, GST)
• Proof of Ownership or Lease of Manufacturing Premises
• Details and Qualifications of Technical Staff
• Fire Safety NOC
• Pollution Control NOC
• Device Master File (DMF) – covering design, specifications, and manufacturing process (Device Master File guide)
• Plant Master File (PMF) – detailing manufacturing facility and equipment (Plant Master File guide)
• Essential Principles Checklist confirming compliance with applicable standards
• Risk Management File specifically addressing electrical safety and patient support risks (Risk Management)
• Test Reports from Government Approved Testing Laboratories
• Labels and Instructions for Use (IFU)
• Quality Management System (QMS) Documents (ISO 13485 certification preferred)

Import License Process (MD15) for ENT Chair, Electric

While this guide focuses on manufacturing, importers intending to bring ENT chairs into India will require an MD15 import license from the Central Licensing Authority.

The process involves:

• Document preparation including manufacturing license, Free Sale Certificate, ISO 13485 certification, CE certificate, device and plant master files
• Application submission on the CDSCO MD Online Portal
• Resolution of departmental queries
• Grant of MD15 license

Import licenses typically take 5-6 months and incur higher fees than manufacturing licenses.

For detailed guidance, refer to our Import License Guide.

Timeline and Processing Duration

Understanding these timelines helps manufacturers plan product launches and inventory management effectively.

Government Fees and Costs

For the ENT chair, electric, a Class A device, the fees are as follows:

• Test License (MD13): Included in application fees
• MD5 Manufacturing License Application Fee: INR 5,000 per application
• Product Registration Fee: INR 500 per product

Additional costs may include laboratory testing fees and notified body audit charges. Budgeting for these early avoids surprises.

Common Challenges and Solutions

Challenge: Delays due to incomplete documentation or non-compliance in audits.

Solution: Engage experienced consultants to perform a gap analysis before submission. Use our detailed checklist to ensure all documents (Device Master File, Risk Management File, QMS) meet CDSCO standards.

Challenge: Difficulty in coordinating product testing with government laboratories.

Solution: Schedule testing early and select labs from the official list of testing laboratories to avoid delays.

Challenge: Responding to audit observations and departmental queries.

Solution: Maintain open communication with the licensing authority and promptly address all requests with precise documentation.

Expert Consultation and Support

Our team has successfully guided over 500 companies through the CDSCO licensing journey. We offer:

• Comprehensive pre-submission audits
• Preparation of technical and regulatory documentation
• Liaison with notified bodies and CDSCO inspectors
• Strategic planning to optimize timelines and minimize costs

Partnering with experts ensures your ENT chair manufacturing license is approved without avoidable delays.

Getting Started with Your CDSCO License Application for ENT Chair, Electric

1. Evaluate Your Current Status: Confirm your manufacturing premises, technical team, and QMS readiness.

2. Gather Required Documentation: Use our document checklist to assemble all files, including Device and Plant Master Files.

3. Apply for the Test License (MD13): Submit your initial application via the CDSCO MD Online Portal.

4. Schedule Product Testing: Coordinate with a government-approved testing laboratory early.

5. Prepare for Audit: Engage a notified body for the mandatory audit, ensuring all quality processes are in place.

6. Submit MD5 License Application (Form MD3): After successful testing and audit, submit the final manufacturing license application.

7. Respond to Queries Promptly: Address any CDSCO or notified body questions efficiently to avoid hold-ups.

By following this structured approach and leveraging our expert support, manufacturers of the ENT chair, electric can confidently navigate the CDSCO licensing process and successfully enter the Indian market.

For further assistance and tailored consultancy, reach out to our regulatory experts who specialize in medical device compliance.

For more information, visit the official CDSCO MD Online Portal.