CDSCO License for Paediatric dental chair, mechanical

Comprehensive Guide to CDSCO Licensing for Paediatric Dental Chair (Mechanical)

As a trusted regulatory consultancy with over 25 years of experience assisting 500+ medical device companies, we understand the critical importance of securing timely and compliant CDSCO licenses. The paediatric dental chair (mechanical) is a Class B medical device designed specifically for pediatric dental care. It supports young patients in a seated position during examinations, treatments, and minor surgeries, with features such as adjustable height, reclining backrests, and rotating capabilities.

Navigating the CDSCO regulatory framework for this device requires precise understanding of risk classification, documentation, and procedural timelines. This guide offers detailed, actionable insights to help manufacturers and importers confidently obtain their manufacturing or import license for the Indian market.

CDSCO Regulatory Framework for Paediatric Dental Chair (Mechanical)

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India under the Medical Device Rules (MDR) 2017. Since August 2020, many devices including paediatric dental chairs have been regulated as notified medical devices. The regulatory pathway depends on the device's risk classification.

For the paediatric dental chair, classified as Class B (low-moderate risk), the applicable manufacturing license is the MD5 license issued by the State Licensing Authority, while import licenses are granted by the Central Licensing Authority.

Risk Classification and License Requirements

The paediatric dental chair falls under Class B medical devices. According to the categorization detailed in the Medical Device Classification guide, Class B devices require compliance with specific documentation, testing, and inspections before market authorization.

• Manufacturing License: MD5 (Application Form MD3) via State Authority
• Import License: MD15 (Application Form MD14) via Central Authority

This classification influences the licensing process, timelines, and fees.

Manufacturing License Process (MD5) for Paediatric Dental Chair (Class B)

Obtaining an MD5 manufacturing license involves several sequential steps:

1. Test License Application (Form MD13): Before full license approval, you must obtain a test license allowing product testing from government-approved laboratories. This process takes approximately 1.5 to 2 months.

2. Product Testing: Conduct mandatory testing of the paediatric dental chair at CDSCO-approved labs. These labs assess safety, performance, and compliance with essential principles. Refer to the Testing Laboratories list for approved facilities.

3. Document Preparation: Compile comprehensive documents including Device Master File, Plant Master File, Risk Management File, QMS documents, and product labels.

4. Submit MD5 License Application (Form MD3): File your application via the CDSCO MD Online Portal with all required documentation.

5. Audit by Notified Body: An audit by an approved notified body is mandatory. You can check the Notified Bodies List for authorized auditors.

6. Resolution of Queries: Respond promptly to any queries from CDSCO or the notified body.

7. Grant of License (Form MD5): Upon satisfactory review, the license is issued.

The entire process generally takes 3 to 4 months, including test license issuance, testing, audit, and final approval.

Manufacturing License Documents Required for Paediatric Dental Chair

To ensure a smooth application, prepare the following documents:

• Company Constitution (Incorporation Certificate, MOA/AOA)
• Proof of ownership or lease of manufacturing premises
• Technical staff qualifications and experience certificates
• Fire NOC and Pollution Control Board NOC
• Device Master File (detailed device specifications, design, manufacturing process) – see our Device Master File guide
• Plant Master File (facility details, quality controls) – refer to the Plant Master File Guide
• Essential Principles Checklist compliance
• Risk Management File documenting hazard analysis and mitigation measures – learn more about Risk Management
• Test Reports from CDSCO-approved laboratories
• Labels and Instructions for Use (IFU) aligned with Indian regulations
• Quality Management System (QMS) documentation (typically ISO 13485 compliant)

Import License Process (MD15) for Paediatric Dental Chair

If you are an importer, the MD15 license granted by the Central Licensing Authority is mandatory.

Steps include:

1. Document Preparation: Assemble required documents including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certificate, CE Certificate (if applicable), Device Master File, Plant Master File, wholesale license, and company constitution.

2. Submitting Application (Form MD14): File your application on the CDSCO MD Online Portal.

3. Query Resolution: Address any questions or clarifications from CDSCO.

4. License Issuance (Form MD15): Upon clearance, the import license is granted.

The process typically takes 5 to 6 months due to rigorous document verification and compliance checks.

Import License Documents Required

Prepare the following:

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

Timeline and Processing Duration

Planning ahead is crucial. Initiate documentation and testing early to avoid delays.

Government Fees and Costs

• MD5 License: Rs. 5,000 per application + Rs. 500 per product
• MD15 Import License: Fees vary by risk class and site:
  • Class B: Rs. 2000 per site + Rs. 1000 per product

Budget for additional costs such as notified body audits and testing fees.

Common Challenges and Solutions

• Delayed Test Reports: Engage with CDSCO-approved labs early and schedule testing in advance.
• Incomplete Documentation: Use our comprehensive checklists and templates to avoid rejections.
• Audit Non-compliance: Prepare your manufacturing site and QMS rigorously; conduct internal audits prior to official inspection.
• Query Resolution Delays: Assign a dedicated regulatory liaison to promptly address CDSCO queries.

Expert Consultation and Support

Navigating CDSCO licensing can be complex. Our team has supported over 500 companies in successfully obtaining MD5 and MD15 licenses for Class B devices like the paediatric dental chair. We offer tailored services including gap analysis, document preparation, audit readiness, and liaison with CDSCO authorities to expedite your approval process.

Getting Started with Your CDSCO License Application

1. Evaluate Your Device Classification: Confirm Class B categorization.
2. Prepare Test License Application: Submit Form MD13 on the CDSCO MD Online Portal to commence testing.
3. Engage Approved Testing Labs: Schedule product testing early.
4. Compile Required Documentation: Utilize our guides on Device Master File and Plant Master File.
5. Select Notified Body for Audit: Choose from the list of notified bodies.
6. Apply for MD5 License (Form MD3): After successful testing and documentation, file your application online.
7. Prepare for Audit and Query Resolution: Be ready to respond efficiently.

Starting early and partnering with experienced consultants can significantly reduce approval timelines and increase compliance confidence. Reach out to us today to kickstart your journey towards CDSCO licensing for your paediatric dental chair.

For more detailed insights, explore our specialized guides on MD5 License, Device Master File, and Risk Management.

Your success in the Indian market begins with compliance – let us help you achieve it efficiently and effectively.