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CDSCO License for Paediatric dental chair, electric

Medical Device Information

Device Class
Class B

Intended Use

A mains electricity (AC-powered) device designed to support a paediatric patient in a seated position to facilitate dental examination, treatment, and/or minor surgery procedures. It is typically adjustable in height to enable healthcare staff to perform procedures while standing. It usually includes head and armrests, a reclining back that may be tilted from a vertical to a horizontal position, and has rotating capabilities; some types can be programmed to several standard positions. Devices intended for dental examination and/or treatment (e.g., lights, irrigation) may be attached as components of the chair, or stand separately as self-  supported, wall- or ceiling-mounted units.

Manufacturing License
MD5
Import License
MD15
CDSCO License for Paediatric dental chair, electric

Comprehensive CDSCO Licensing Guide for Paediatric Dental Chair (Electric) – Class B Medical Device

Introduction: Understanding Paediatric Dental Chairs and Regulatory Importance

Paediatric dental chairs, electric-powered and designed specifically for children, play a critical role in dental care by providing ergonomic support for examinations, treatments, and minor surgical procedures. Their adjustable features such as reclining backrests, head and armrests, and programmable positioning make them indispensable in pediatric dentistry setups. Given their direct interface with patients and reliance on mains electricity, these devices are classified as Class B medical devices under CDSCO regulations, requiring stringent compliance to ensure safety and efficacy.

Navigating the Central Drugs Standard Control Organisation (CDSCO) licensing process is essential for manufacturers and importers aiming to market these devices in India. As regulatory consultants with over 25 years of experience and having supported 500+ companies, we provide an in-depth roadmap tailored for the Paediatric Dental Chair (electric) to facilitate hassle-free licensing.

CDSCO Regulatory Framework for Paediatric Dental Chairs (Electric)

Medical devices in India are regulated by CDSCO under the Medical Device Rules, 2017. The Paediatric Dental Chair (electric) falls under Class B, which denotes a low to moderate risk category. Compliance with standards related to electrical safety, mechanical stability, and biocompatibility is mandatory. The regulatory framework mandates obtaining a manufacturing license (MD5) or import license (MD15) before market entry.

You can initiate all licensing applications through the official CDSCO MD Online Portal, ensuring transparency and trackability.

Risk Classification and License Requirements for Paediatric Dental Chair

  • Risk Class: B (Low to Moderate Risk)
  • Applicable License: MD5 Manufacturing License (via Form MD3)
  • Regulatory Authority: State Licensing Authority (SLA)
  • Notification Reference: File No. 29/MiscJ03/2020-DC (150), dated 23.8.2021

For Class B devices like Paediatric Dental Chairs, the MD5 license process is designed to balance rigorous quality assurance with streamlined procedures suitable for lower-risk devices.

Manufacturing License Process (MD5) for Paediatric Dental Chair

The MD5 license process encompasses several key stages:

  1. Test License Application (Form MD13): Before the full manufacturing license, a test license is mandatory. This permits manufacturing for testing and evaluation.
  2. Product Testing: Conducted at CDSCO-approved laboratories to validate compliance with applicable standards.
  3. Document Preparation: Compilation of technical files, master files, and quality management system documentation.
  4. Application Submission: Application for the MD5 license is submitted via Form MD3 on the CDSCO MD Online Portal.
  5. Audit by Notified Body: An audit of the manufacturing site and QMS is conducted by a CDSCO-recognized notified body.
  6. Response to Queries: Address any clarifications or deficiencies raised by CDSCO or the notified body.
  7. Grant of License: Upon successful review, the manufacturing license (Form MD5) is issued.

Manufacturing License Documents Required for Paediatric Dental Chairs

Accurate and thorough documentation is critical. The following are typically required:

  • Company Constitution Documents: Incorporation certificate, memorandum and articles of association.
  • Proof of Premises Ownership or Lease: Valid legal documents for manufacturing site.
  • Technical Staff Credentials: Qualification and experience certificates of personnel involved.
  • Fire NOC and Pollution Control NOC: Compliance certificates from local authorities.
  • Device Master File (DMF): Detailed design, specifications, manufacturing process, and validation documents. Refer to our comprehensive Device Master File guide for preparation tips.
  • Plant Master File (PMF): Details of manufacturing facilities and quality controls, explained in our Plant Master File Guide.
  • Essential Principles Checklist: Compliance with Indian Medical Device Rules and international standards.
  • Risk Management File: Identification and mitigation strategies tailored to electrical and mechanical risks. See our insights on Risk Management.
  • Test Reports: Certification from CDSCO-approved testing laboratories. View the Testing Laboratories list.
  • Labels and Instructions for Use (IFU): Detailed labeling per regulatory standards.
  • Quality Management System Documents: ISO 13485:2016 certification and internal procedures.

Import License Process (MD15) Overview

While this guide primarily addresses manufacturers, importers of Paediatric Dental Chairs must obtain an MD15 import license through the Central Licensing Authority. The process includes document submission, verification, and license issuance. Unlike MD5, a test license is not required.

Key documents required include a valid manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device and Plant Master Files, Wholesale License, and Company Constitution.

For detailed guidance, refer to our Import License Guide.

Timeline and Processing Duration for MD5 License

The total timeline for obtaining an MD5 license for the Paediatric Dental Chair (Class B) typically spans 3 to 4 months, broken down as follows:

  • Test License (MD13): 1.5 to 2 months
  • Product Testing at CDSCO-approved labs: 3 to 4 weeks
  • Application Submission and Audit Scheduling: 2 to 3 weeks
  • Audit and Query Resolution: 3 to 4 weeks
  • Final Grant of License: 1 to 2 weeks

This timeline can vary based on the completeness of documentation and responsiveness to queries. Early preparation and expert guidance significantly reduce delays.

Government Fees and Costs for MD5 License

  • Application Fee: Rs. 5,000 per application
  • Per Product Fee: Rs. 500 per product

Additional costs include:

  • Testing fees charged by approved laboratories
  • Audit fees payable to notified bodies (varies; check the list of notified bodies)
  • Consultancy and document preparation support (optional but recommended)

Common Challenges and Practical Solutions

  • Incomplete or Inaccurate Documentation: Ensure all technical files and certificates are thoroughly prepared. Use checklists and cross-verify all documents before submission.
  • Delays in Product Testing: Schedule testing early. Choose CDSCO-approved labs known for prompt service.
  • Audit Non-Compliance: Conduct internal pre-audits and staff training to avoid deficiencies.
  • Query Resolution Delays: Assign dedicated personnel to respond promptly with detailed explanations.

Expert Consultation and Support

Navigating the CDSCO licensing landscape can be complex. Our team, with over 25 years of regulatory consulting experience, has helped more than 500 companies successfully obtain their MD5 licenses. We provide end-to-end services from document preparation, gap analysis, test lab coordination, to audit readiness and query management.

Getting Started with Your CDSCO License Application for Paediatric Dental Chairs

  1. Assess your Device Classification: Confirm that your device is correctly classified as Class B.
  2. Prepare Initial Documentation: Begin compiling company documents, technical files, and QMS certifications.
  3. Apply for Test License (Form MD13): Submit via the CDSCO MD Online Portal to begin manufacturing for testing.
  4. Schedule Product Testing: Coordinate with CDSCO-approved labs early to avoid delays.
  5. Develop Device and Plant Master Files: Utilize expert templates and guides linked above.
  6. Submit MD5 License Application (Form MD3): After successful testing and documentation readiness.
  7. Prepare for Audit: Engage a notified body listed here for on-site inspection.
  8. Respond to Queries Promptly: Maintain clear communication with CDSCO and notified bodies.

Starting your licensing journey with a clear plan and expert support ensures timely approval and market entry for your paediatric dental chair. Contact us today to leverage our proven expertise and simplify your regulatory pathway.

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About the Author

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Tails Azimuth
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