CDSCO License for Bone Chisel

Comprehensive Guide to CDSCO Licensing for Bone Chisel (Class A Medical Device)

When it comes to orthopedic surgical instruments like the Bone Chisel, regulatory compliance is critical to ensure patient safety and market access in India. As seasoned regulatory consultants with over 25 years of experience and having supported 500+ companies, we provide you with an in-depth, step-by-step guide to obtaining your CDSCO manufacturing license for Bone Chisel, a Class A device.

Understanding Bone Chisel and Its Regulatory Importance

A Bone Chisel is a single-bladed surgical instrument, bevelled on one side, designed specifically for cutting or contouring bone during orthopedic surgeries. Given its direct contact with bone tissue and its critical role in surgical procedures, it is categorized under General Hospital or Orthopaedic Instruments and notified as per Notification 29/Misc./03/2020-DC (193)- Part-3 dated 16.03.2022.

Regulatory oversight by CDSCO (Central Drugs Standard Control Organization) ensures the device meets stringent quality and safety standards before entering the Indian market.

CDSCO Regulatory Framework for Bone Chisel (Class A Device)

As a Class A medical device (low risk), the Bone Chisel falls under the purview of the State Licensing Authority for manufacturing licenses. The regulatory framework mandates compliance with the Medical Devices Rules, 2017, and adherence to the essential principles of safety and performance.

You are required to apply for an MD5 license using Form MD3 for manufacturing, following successful completion of pre-license testing and audit.

Risk Classification and License Requirements

• Risk Class: A (Low risk)
• License Type: MD5 (Manufacturing License for Class A & B devices)
• Authority: State Licensing Authority
• Application Form: MD3

For detailed device classification insight, you may refer to our Medical Device Classification guide.

Manufacturing License Process for Bone Chisel (MD5)

The manufacturing license process involves several critical steps:

1. Test License (Form MD13) – Obtain a test license valid for 6 months to manufacture samples for testing. This phase typically takes 1.5 to 2 months.

2. Product Testing – Conduct mandatory testing in CDSCO-approved laboratories to verify compliance with Indian Standards. Refer to the list of testing laboratories for authorized facilities.

3. Document Preparation – Prepare comprehensive documents including Device Master File (DMF), Plant Master File (PMF), Essential Principles Checklist, Risk Management file, Quality Management System (QMS) documentation, and detailed product labeling.

4. Application Submission – Submit the application for MD5 license through the CDSCO MD Online Portal using Form MD3.

5. Audit by Notified Body – The State Licensing Authority will appoint an independent notified body for audit. Check the list of notified bodies for potential auditors.

6. Resolution of Queries – Respond promptly to any queries raised by the licensing authority or auditor.

7. Grant of License – Upon satisfactory audit and document review, the MD5 license will be granted in Form MD5.

The entire process generally takes 3 to 4 months from test license issuance to final license grant.

For a detailed walkthrough, our MD5 License Guide is a valuable resource.

Manufacturing License Documents Required for Bone Chisel

To avoid delays, ensure the following documents are meticulously prepared and submitted:

• Company Constitution / Incorporation Certificate
• Proof of Ownership or Lease Agreement of Manufacturing Premises
• Documents of Qualified Technical Staff (e.g., production, quality control)
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF) detailing design, manufacturing, and control processes (Guide here)
• Plant Master File (PMF) covering manufacturing environment and facilities (Guide here)
• Essential Principles Compliance Checklist
• Risk Management File demonstrating hazard identification and mitigation (Risk Management Guide)
• Test Reports from CDSCO-approved labs
• Product Labels and Instructions for Use (IFU)
• Quality Management System documents, preferably ISO 13485:2016 certification

Import License Process for Bone Chisel (MD15)

If you plan to import Bone Chisel instead of manufacturing locally, you must apply for the MD15 import license via Form MD14 through the central authority. This process usually takes 5 to 6 months.

Documents required include:

• Valid manufacturing license from the country of origin
• Free Sale Certificate
• ISO 13485:2016 and CE Certificate
• Device Master File and Plant Master File
• Wholesale license
• Company Constitution

For more details, review our Import License Guide.

Timeline and Processing Duration

Government Fees and Costs

Example: For manufacturing Bone Chisel, expect a base fee of Rs. 5,000, plus Rs. 500 for the device.

Common Challenges and Solutions

• Delayed Test Reports: Engage with CDSCO-approved labs early to schedule testing and avoid bottlenecks.
• Incomplete Documentation: Utilize checklists and professional templates for DMF and PMF to ensure completeness.
• Audit Non-Compliance: Conduct internal pre-audit assessments against notified body checklists.
• Query Resolution Delays: Assign a dedicated regulatory liaison to respond promptly.

Expert Consultation and Support

Navigating the CDSCO regulatory landscape can be complex, especially for first-time applicants. Our extensive experience in guiding over 500 clients through successful CDSCO license approvals means we can offer tailored services including:

• Gap analysis and compliance readiness
• Document drafting and review
• Test license and manufacturing license application assistance
• Coordination with notified bodies and labs
• Post-license regulatory support

Getting Started with Your CDSCO License Application

1. Assess your manufacturing setup and ensure compliance with GMP and QMS requirements.
2. Initiate test license application (Form MD13) via the CDSCO MD Online Portal.
3. Engage with CDSCO-approved testing labs early to schedule product testing.
4. Prepare your Device Master File and Plant Master File using expert templates.
5. Gather all statutory and technical documents including fire and pollution NOCs.
6. Submit your MD3 application for MD5 license post successful testing.
7. Coordinate audit scheduling with the notified body and prepare your team.

For professional assistance and to ensure a smooth, compliant journey to market, connect with our expert regulatory consultants today.

Embark on your CDSCO licensing process confidently—with expert insights and practical support tailored specifically for Bone Chisel manufacturers.