CDSCO License for Pedical Screw Instruments

Comprehensive CDSCO Licensing Guide for Pedical Screw Instruments (Class A Medical Device)

As a trusted regulatory consultancy with over 25 years of experience and a track record of assisting 500+ companies in obtaining CDSCO licenses, we understand the critical importance of compliance for medical devices like Pedical Screw Instruments. These instruments — including rocker, tap breaker, persuader, sound, and quick change tools — play an essential role in aiding surgeons during spinal fusion surgeries. Given their classification as Class A devices under the General Hospital or Orthopaedic Instruments category, navigating the CDSCO regulatory pathway efficiently is vital for timely market entry in India.

CDSCO Regulatory Framework for Pedical Screw Instruments

The Central Drugs Standard Control Organization (CDSCO) governs medical device licensing in India. Pedical Screw Instruments fall under Class A, the lowest risk category, notified under 29/Misc./03/2020-DC (193)-Part-3 dated 16.03.2022. This classification means the licensing authority is the State Licensing Authority and the applicable license is the MD5 Manufacturing License.

Risk Classification and License Requirements

• Device Name: Pedical Screw Instruments
• Risk Class: Class A (Low Risk)
• Category: General Hospital or Orthopaedic Instruments
• Applicable License: MD5 Manufacturing License (Form MD3 application)
• Regulatory Authority: State Licensing Authority

For Class A devices, the MD5 license is mandatory for manufacturers intending to produce these instruments within India.

Manufacturing License Process (MD5 License)

The MD5 license process is structured and detailed, ensuring safety and quality compliance. Here’s an overview:

1. Apply for Test License (Form MD13): Before the manufacturing license, a test license is required. This allows product testing in government-approved labs.
2. Product Testing: Samples of Pedical Screw Instruments must be tested at notified laboratories.
3. Document Preparation: Compile essential documents including Device Master File (DMF), Plant Master File (PMF), Risk Management File, and QMS documents.
4. Submit Manufacturing License Application (Form MD3): This application is submitted through the CDSCO MD Online Portal.
5. Audit by Notified Body: A notified body audits your manufacturing facility and quality systems.
6. Address Queries: Respond promptly to any observations or queries from the licensing authority or notified body.
7. Grant of License (Form MD5): Upon satisfactory compliance, the MD5 manufacturing license is granted.

For a detailed stepwise process, our MD5 License Guide is an excellent resource.

Manufacturing License Documents Required

To ensure a smooth application process, prepare the following key documents:

• Company Constitution (Registration Certificate, Memorandum of Association)
• Proof of Ownership/Lease of Manufacturing Premises
• Technical Staff Details (Qualifications and Experience)
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF): Comprehensive documentation of design, specifications, and manufacturing processes. Learn more from our Device Master File guide.
• Plant Master File (PMF): Details about the manufacturing facility, equipment, and quality control systems. Refer to our Plant Master File guide.
• Essential Principles Checklist as per CDSCO requirements
• Risk Management File: Demonstrating compliance with safety standards. For insights, visit our Risk Management guide.
• Test Reports from government-approved laboratories
• Labels and Instructions for Use (IFU)
• Quality Management System (QMS) Documents: ISO 13485 certification is highly recommended

Import License Process (MD15 License)

While our focus here is manufacturing, for importers the MD15 license is applicable. This process involves document preparation, application submission (Form MD14), and approvals by the Central Licensing Authority, taking approximately 5-6 months. For detailed information, refer to our Import License Guide.

Import License Documents Required

For importers, key documents include:

• Valid Manufacturing License
• Free Sale Certificate from the country of origin
• ISO 13485:2016 Certification
• CE Certificate or equivalent
• Device and Plant Master Files
• Wholesale License
• Company Constitution

Timeline and Processing Duration

For Pedical Screw Instruments (Class A), the entire MD5 licensing process usually spans 3 to 4 months. This includes:

• Test License Processing: 1.5 to 2 months
• Product Testing: 2 to 4 weeks depending on lab schedules
• Application Review and Audit: 4 to 6 weeks
• Query Resolution: 2 to 4 weeks

Proactive preparation and quick response to queries can significantly reduce delays.

Government Fees and Costs

The fee structure for an MD5 license is economical, making market entry accessible for startups and SMEs:

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

Additional costs include testing fees at notified laboratories and audit fees charged by notified bodies. For a list of notified bodies authorized for audits, consult the CDSCO portal.

Common Challenges and Solutions

Challenge 1: Delays in Product Testing

• Solution: Engage with notified testing laboratories early. Refer to the Testing Laboratories list and schedule testing slots in advance.

Challenge 2: Incomplete Documentation

• Solution: Utilize comprehensive checklists for DMF, PMF, and Risk Management files. Our guides provide templates and best practices.

Challenge 3: Audit Non-Compliance

• Solution: Conduct internal mock audits and ensure QMS compliance before the notified body inspection.

Challenge 4: Query Resolution Delays

• Solution: Designate a knowledgeable regulatory point of contact to respond promptly and accurately.

Expert Consultation and Support

With over 25 years of regulatory expertise and helping 500+ companies, we provide end-to-end support including:

• Gap analysis and documentation preparation
• Coordination with notified bodies and testing labs
• Strategic planning to minimize timelines and costs
• Training on CDSCO compliance requirements

Our client-centric approach ensures you avoid common pitfalls and achieve licensing success swiftly.

Getting Started with Your CDSCO License Application

1. Assess Device Classification: Confirm your Pedical Screw Instruments fall under Class A by reviewing the latest CDSCO notifications.
2. Engage a Regulatory Consultant: Early expert involvement saves time and resources.
3. Prepare Test Samples: Arrange samples for government-approved lab testing.
4. Compile Required Documents: Use our Device Master File and Plant Master File templates to prepare thorough documentation.
5. Apply for Test License (Form MD13): Submit through the CDSCO MD Online Portal and track progress.
6. Plan for Audit: Schedule audits with notified bodies listed on the CDSCO website.
7. Submit MD5 Application (Form MD3): Once testing and documentation are in order.

By following these actionable steps and leveraging our expertise, manufacturers of Pedical Screw Instruments can confidently navigate CDSCO licensing, ensuring compliance, patient safety, and timely market access in India.