CDSCO License for Accelerator system chair

Introduction to Accelerator System Chair and Its Regulatory Importance

The Accelerator System Chair is an essential medical device component, designed specifically for oncology applications. It serves as a specialized seat to support and position patients during radiation therapy treatments involving medical linear or non-linear accelerators. Given its critical role in patient safety and treatment precision, regulatory compliance with CDSCO (Central Drugs Standard Control Organization) in India is mandatory before manufacturing or importing this Class C device.

With over 25 years of experience and having assisted more than 500 companies in obtaining CDSCO licenses, we understand the nuances and compliance demands for such devices. This comprehensive guide will help you navigate the licensing process, detailing timelines, costs, and documentation specific to the Accelerator System Chair.

CDSCO Regulatory Framework for Accelerator System Chair

The Accelerator System Chair falls under the oncology device category and is classified as a Class C medical device according to CDSCO’s risk classification system. This classification mandates a central licensing route for manufacturing (MD9 License) and import (MD15 License).

The regulatory pathway ensures that the device meets stringent safety, quality, and performance standards, aligning with the Government of India’s commitment to patient safety and effective therapy outcomes.

Risk Classification and License Requirements for Class C Devices

Class C devices represent moderate to high risk and require rigorous conformity assessment. For the Accelerator System Chair, the following licenses are essential:

• Manufacturing License (MD9): Issued by the Central Licensing Authority.
• Import License (MD15): Issued by the Central Licensing Authority for importing devices into India.

Understanding this classification is critical before initiating any licensing process. For more details, manufacturers can review the Medical Device Classification guide.

Manufacturing License Process (MD9) for Accelerator System Chair

The MD9 license process involves several stages and typically takes 4 to 5 months from start to finish. Here's a step-by-step overview:

1. Test License Application (Form MD13): Initially, you must apply for a test license which takes approximately 1.5 to 2 months. This allows you to manufacture samples for testing.
2. Product Testing: The device must be tested in Government-approved laboratories to ensure compliance with applicable standards. Detailed lists of testing laboratories can be found on the CDSCO portal.
3. Document Preparation: Prepare the required documentation including Device Master File, Plant Master File, Risk Management File, and Quality Management System (QMS) documents.
4. License Application (Form MD7): Submit your application for the MD9 manufacturing license via the CDSCO MD Online Portal.
5. Audit by CDSCO Inspectors: An on-site inspection is conducted by CDSCO to verify compliance.
6. Query Resolution: Address any queries raised during audit or document review.
7. Grant of License (Form MD9): Upon satisfactory compliance, the manufacturing license is granted.

For more detailed guidance on the MD9 process, refer to our MD9 License Guide.

Manufacturing License Documents Required for Class C Devices

The document package is comprehensive and typically includes:

• Company Constitution and Incorporation Certificates
• Proof of Ownership or Lease of Manufacturing Premises
• Details and Qualifications of Technical Staff
• Fire NOC and Pollution Control Board NOC
• Device Master File detailing device design, specifications, and manufacturing processes (Device Master File guide)
• Plant Master File outlining manufacturing infrastructure and quality systems (Plant Master File guide)
• Essential Principles Checklist aligned with Indian regulations
• Risk Management File demonstrating compliance with ISO 14971 (Risk Management guide)
• Test Reports from certified labs
• Labeling and Instructions for Use (IFU)
• Quality Management System Documents (ISO 13485:2016 certification preferred)

Ensuring the accuracy and completeness of these documents can significantly reduce processing time and avoid repeated queries.

Import License Process (MD15) for Accelerator System Chair

For companies planning to import the Accelerator System Chair into India, obtaining an MD15 import license is mandatory. The process typically takes 5 to 6 months and involves:

1. Document Compilation: Prepare import license application with all required documentation.
2. Application Submission: File the application using Form MD14 on the CDSCO MD Online Portal.
3. Review and Query Handling: CDSCO reviews the submission and may raise queries needing prompt resolution.
4. License Issuance (Form MD15): Upon successful review, the import license is granted.

No test license is required for importers; however, documentation proving compliance is critical. For detailed steps, consult our Import License Guide.

Import License Documents Required

Key documents needed for MD15 license include:

• Valid Manufacturing License from the country of origin
• Free Sale Certificate indicating device is legally sold in the export country
• ISO 13485:2016 Certificate
• CE Certificate or equivalent international quality certification
• Device Master File and Plant Master File
• Wholesale License (if applicable)
• Company Constitution and Incorporation Documents

Thorough preparation of these documents expedites the import licensing process.

Timeline and Processing Duration

Manufacturers should plan accordingly to meet market launch timelines.

Government Fees and Costs

The fee structure for the Accelerator System Chair (Class C device) is as follows:

• MD9 Manufacturing License: ₹50,000 per application plus ₹1,000 per product
• MD15 Import License: $3,000 per site plus$1,500 per product, payable in USD

Additional costs include fees for testing in government-approved laboratories and audit expenses. Early budgeting helps avoid financial delays.

Common Challenges and Solutions

Challenge: Delays due to incomplete documentation or non-compliance with CDSCO norms.

Solution: Engage expert consultants to pre-validate documents, use checklists, and maintain a clear audit trail.

Challenge: Prolonged testing timelines at government labs.

Solution: Select labs with shorter lead times from the list of approved testing laboratories and submit samples promptly.

Challenge: Audit non-conformities leading to repeated inspections.

Solution: Conduct internal audits and mock inspections prior to CDSCO visits.

Expert Consultation and Support

Our team, with decades of expertise, provides end-to-end support for Accelerator System Chair manufacturers and importers. We assist in:

• Preparing and reviewing comprehensive documentation
• Coordinating with notified bodies and testing labs
• Managing online submissions via the CDSCO MD Online Portal
• Resolving audit and departmental queries swiftly
• Ensuring compliance with the latest CDSCO guidelines and amendments

This proactive approach has helped over 500 companies successfully obtain their CDSCO licenses with minimal delays.

Getting Started with Your CDSCO License Application for Accelerator System Chair

1. Assess Your Product Classification: Confirm your device is Class C and requires MD9 and/or MD15 licenses.
2. Gather Required Documentation: Use our referenced guides to assemble Device Master File, Plant Master File, Risk Management File, and other critical documents.
3. Apply for Test License (for Manufacturing): Submit Form MD13 via the CDSCO MD Online Portal to commence sample production.
4. Coordinate Product Testing: Partner with government-approved labs early to schedule testing.
5. Prepare and Submit License Application: After successful testing, apply for the MD9 manufacturing license or the MD15 import license as applicable.
6. Plan for Audits and Queries: Allocate resources to respond promptly to CDSCO inspections and queries.

Starting early and working with seasoned regulatory experts can streamline your pathway to market authorization for your Accelerator System Chair in India. For personalized consultation, do not hesitate to contact us.

We are committed to helping you achieve timely and compliant CDSCO licensing, enabling safe and effective oncology treatments with your Accelerator System Chair.