CDSCO License for Six axis correction apparatus with software

Comprehensive Guide to CDSCO Licensing for Six Axis Correction Apparatus with Software (Class B Medical Device)

Entering the Indian medical device market with your Six Axis Correction Apparatus and software—a sophisticated system designed to correct multi-plane bone deformities or fractures—requires a thorough understanding of the CDSCO regulatory framework. Given its classification as a Class B device under the General Hospital or Orthopaedic Instruments category, this device demands compliance with specific licensing procedures that ensure safety, efficacy, and quality standards.

With over 25 years of expertise and having supported 500+ companies in securing CDSCO approvals, we provide you with a detailed roadmap to navigate the complexities involved in obtaining your manufacturing or import license smoothly and efficiently.

CDSCO Regulatory Framework for Six Axis Correction Apparatus

Your device falls under the ambit of the Central Drugs Standard Control Organization (CDSCO), which regulates medical devices in India. The notification governing your device is 29/Misc./03/2020-DC (193)- Part-3, dated 16.03.2022. This notification classifies the device as Risk Class B, denoting moderate risk, which aligns with the regulatory controls and licensing requirements stipulated by CDSCO.

Understanding this framework is crucial because it affects the licensing authority involved, documentation needed, timelines, and fees.

Risk Classification and License Requirements

As per CDSCO’s classification system, your Six Axis Correction Apparatus, including its software component, is categorized as a Class B medical device. This classification requires a manufacturing license under the MD5 category, which is granted by the State Licensing Authority.

The MD5 license corresponds to moderate risk devices and involves a multi-step evaluation process including test licensing, product testing, and audit by a notified body. For importers, the MD15 import license issued by the Central Licensing Authority is applicable.

For more detailed insights about device classification, please refer to our Medical Device Classification guide.

Manufacturing License Process (MD5)

Step 1: Apply for Test License (Form MD13)

Before you can apply for the full manufacturing license, it is mandatory to obtain a test license. This license allows you to manufacture the device for sample testing purposes. Processing time for this stage typically takes 1.5 to 2 months.

Step 2: Product Testing

Your device must be tested by government-approved laboratories to verify compliance with applicable standards. Testing laboratories can be found on the CDSCO Testing Laboratories list.

Step 3: Document Preparation and Submission

Once test results are satisfactory, prepare the comprehensive documentation package and submit your application for the manufacturing license using Form MD3 through the CDSCO MD Online Portal.

Step 4: Audit by Notified Body

An on-site audit by a notified body is mandatory to assess your manufacturing facility and quality management systems. The list of approved notified bodies is available here.

Step 5: Query Resolution and License Grant

Following the audit, you may receive queries or requests for clarifications from the licensing authority or notified body, which must be addressed promptly to avoid delays. Upon satisfactory compliance, the MD5 license will be granted.

For a comprehensive walkthrough, see our detailed MD5 License Guide.

Manufacturing License Documents Required

To avoid common pitfalls, ensure you have the following documents ready and compliant:

• Company Constitution and Incorporation Certificates
• Proof of ownership/lease of manufacturing premises
• Technical Personnel qualifications and experience documents
• Fire No Objection Certificate (NOC)
• Pollution Control Board NOC
• Device Master File (DMF) detailing device design, components, and manufacturing processes (Guide to Device Master Files)
• Plant Master File (facility and quality systems details) (Plant Master File Guide)
• Essential Principles Checklist demonstrating compliance with regulatory standards
• Risk Management File reflecting identified hazards and mitigation strategies (Risk Management Guide)
• Product Test Reports from government-approved labs
• Device Labels, Instructions for Use (IFU)
• Quality Management System (QMS) documentation compliant with ISO 13485:2016

Ensuring each document is thorough and aligned with CDSCO expectations will expedite the licensing process.

Import License Process (MD15)

If you are an importer of the Six Axis Correction Apparatus, the import license MD15 needs to be obtained from the Central Licensing Authority.

Key Steps Include:

• Prepare all required documents, including existing manufacturing license, Free Sale Certificate from the country of origin, ISO 13485:2016 certification, CE certificate if applicable, Device and Plant Master Files, and wholesale license.
• Apply via the CDSCO MD Online Portal.
• Respond to any queries raised during the evaluation.
• Await license grant, which typically takes 5-6 months.

For a detailed walkthrough, visit our Import License Guide.

Import License Documents Required

• Valid Manufacturing License of Manufacturer
• Free Sale Certificate from Country of Origin
• ISO 13485:2016 Certification
• CE Certificate (if applicable)
• Device Master File
• Plant Master File
• Wholesale License
• Company Constitution and supporting documents

Timeline and Processing Duration

Overall, manufacturers should anticipate approximately 4-5 months from test license application to manufacturing license grant for Class B devices.

Government Fees and Costs

• MD5 License:
  • Application Fee: Rs 5,000 per application
  • Product Fee: Rs 500 per product
• MD15 Import License:
  • Class B: $2,000 per site
  • $1,000 per product

Additional costs include testing fees from government-approved labs and notified body audit charges, which vary depending on the scope and complexity.

Common Challenges and Solutions

• Incomplete Documentation: Ensure all documents, particularly Device and Plant Master Files, are detailed and compliant. Use expert templates or consult guides to avoid rejections.
• Delayed Testing Reports: Engage early with CDSCO-approved labs to schedule testing to fit within your timeline.
• Audit Non-Compliance: Prepare your facility and QMS meticulously; conduct internal pre-audits to identify gaps.
• Query Resolution Delays: Designate a regulatory liaison to respond promptly and accurately to CDSCO and notified body queries.

Expert Consultation and Support

Navigating CDSCO licensing can be complex, especially for specialized devices like the Six Axis Correction Apparatus with software components. Our seasoned consultants offer hands-on support in documentation, audit preparation, testing coordination, and timely submission to ensure your application progresses smoothly.

Getting Started with Your CDSCO License Application

1. Assess Device Classification: Confirm your device’s Risk Class B status and applicable licenses.
2. Engage Accredited Testing Labs: Schedule necessary testing early to avoid bottlenecks.
3. Prepare Comprehensive Documentation: Leverage our detailed guides on Device Master File and Plant Master File.
4. Submit Test License Application (Form MD13): Initiate manufacturing permission for testing via the CDSCO MD Online Portal.
5. Coordinate Notified Body Audit: Select from the list of notified bodies and prepare your facility.
6. Apply for MD5 Manufacturing License: Post successful testing and audit, submit Form MD3 application.

By following these actionable steps and leveraging expert insights, you can significantly reduce approval timelines and position your Six Axis Correction Apparatus for successful market entry in India.

For personalized assistance, reach out to our regulatory experts who have empowered 500+ companies to thrive in the Indian medical device landscape.