CDSCO License for Paediatric dorsiflexion slant board

Comprehensive Guide to CDSCO Licensing for Paediatric Dorsiflexion Slant Board (Class A Medical Device)

The Paediatric dorsiflexion slant board is a specialized physical support device designed to aid children suffering from conditions like congenital deformities, neurological disorders, or post-traumatic complications affecting foot dorsiflexion. By addressing tendon tightness and muscle contracture, this device plays a crucial role in improving gait abnormalities and enhancing pediatric mobility.

Navigating the regulatory landscape in India for such medical devices is essential to ensure compliance, market access, and patient safety. With over 25 years of expertise and having supported 500+ companies, we provide you with a detailed roadmap for obtaining the CDSCO manufacturing license for this Class A device.

CDSCO Regulatory Framework for Paediatric Dorsiflexion Slant Board

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices under the Medical Device Rules, 2017. For devices like the Paediatric dorsiflexion slant board, classified as Class A (low risk), licensing is managed at the State level through the issuance of an MD5 license.

The device falls under the "Physical support" category and is notified under File No. 29/Misc./03/2020-DC (202), dated 26.7.2021. This classification ensures a streamlined process but mandates adherence to quality and safety standards.

Risk Classification and License Requirements for Class A Devices

According to CDSCO’s classification:

• Class A Devices are low-risk and require a manufacturing license known as MD5, issued by the State Licensing Authority.
• The application involves submission of detailed documentation, product testing, and a mandatory audit by a notified body.

For the Paediatric dorsiflexion slant board, the MD5 license is the relevant approval to legally manufacture and market within India.

Manufacturing License Process for Paediatric Dorsiflexion Slant Board (MD5 License)

The MD5 licensing process involves several critical steps:

1. Test License (Form MD13): Obtain a test license that allows you to manufacture the device for testing purposes. This step takes approximately 1.5 to 2 months.
2. Product Testing: Conduct testing at CDSCO-approved laboratories to verify compliance with applicable standards.
3. Document Preparation: Assemble necessary documents including Device Master File, Plant Master File, and Risk Management File.
4. License Application (Form MD3): Submit the manufacturing license application via the CDSCO MD Online Portal for processing.
5. Audit by Notified Body: An audit is conducted by a notified body selected from the official CDSCO list.
6. Resolution of Queries: Address any observations or queries raised by the licensing authority or notified body.
7. Grant of License (Form MD5): Upon successful completion, the license for manufacturing is granted.

For detailed guidance on the MD5 license process, consult our MD5 License Guide.

Manufacturing License Documents Required for Class A Device

To ensure a smooth application, prepare the following documents:

• Company Constitution (Incorporation Certificate, Partnership Deed, etc.)
• Proof of Ownership or Lease of Manufacturing Premises
• Technical Staff Details (Qualifications, Experience, Appointment Letters)
• Fire No Objection Certificate (NOC)
• Pollution Control Board NOC
• Device Master File (DMF) – detailing design, specifications, and manufacturing processes. Our comprehensive Device Master File Guide can assist here.
• Plant Master File (PMF) – describing the manufacturing facility and quality management systems; see our Plant Master File Guide for best practices.
• Essential Principles Checklist confirming compliance with Indian Medical Device Rules.
• Risk Management File – demonstrating risk analysis and mitigation strategies; refer to our Risk Management insights.
• Test Reports from CDSCO-approved laboratories listed here.
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) Documents (e.g., ISO 13485:2016 certification)

Import License Process for Paediatric Dorsiflexion Slant Board (MD15 License)

If you are an importer of this device rather than a manufacturer, you must apply for an MD15 import license through CDSCO’s Central Licensing Authority.

Key steps include:

• Preparation of comprehensive documentation including Manufacturing License, Free Sale Certificate, ISO 13485:2016, CE Certificate (if available), Device and Plant Master Files.
• Submission of application via the CDSCO MD Online Portal.
• Resolution of any departmental queries.
• License grant typically takes 5-6 months.

For a detailed walkthrough, see our Import License Guide.

Import License Documents Required

• Valid 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 (if applicable)
• Company Constitution

Timeline and Processing Duration

The 3-4 months timeline applies to the entire MD5 license process for Class A devices like the paediatric dorsiflexion slant board.

Government Fees and Costs

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

These fees are payable at the time of application submission through the CDSCO portal.

Common Challenges and Practical Solutions

• Incomplete Documentation: Ensure all files like the Device Master File and Risk Management File are meticulously prepared. Utilize templates and professional guidance to avoid rejections.
• Delays in Product Testing: Engage with CDSCO-approved laboratories early. Confirm their testing capacity and timelines beforehand.
• Audit Non-Compliance: Conduct internal mock audits before the notified body visit. Familiarize your team with GMP and QMS requirements.
• Query Resolution Delays: Respond promptly and comprehensively to queries from regulators to avoid process bottlenecks.

Expert Consultation and Support

With decades of experience and over 500 successful CDSCO license approvals, we offer tailored consulting services:

• End-to-end license application management
• Documentation preparation and review
• Internal audits and gap analysis
• Regulatory strategy and compliance roadmap

Our clients benefit from streamlined processes, reduced approval times, and minimal rework.

Getting Started with Your CDSCO License Application

1. Assess Device Classification: Confirm your device as Class A using the Medical Device Classification tool.
2. Prepare Test License Application: Start by applying for the test license (Form MD13) on the CDSCO MD Online Portal.
3. Engage Testing Laboratories: Schedule product testing early to align with your timeline.
4. Compile Documentation: Leverage our guides on Device and Plant Master Files for compliant dossiers.
5. Select a Notified Body: Choose from the list of notified bodies for the mandatory audit.
6. Submit Manufacturing License Application: Apply via the online portal and track your application status regularly.
7. Prepare for Audit and Queries: Facilitate audit readiness and promptly address any queries.

Starting early with detailed preparation is key to successful and timely license approval.

For personalized assistance, connect with our expert regulatory consultants who bring unmatched expertise to your CDSCO licensing journey for the Paediatric dorsiflexion slant board.

By adhering to these guidelines and leveraging our expertise, your path to manufacturing or importing the Paediatric dorsiflexion slant board in India will be efficient, compliant, and successful.