CDSCO License for Orthopaedic Countersink

Comprehensive Guide to CDSCO Licensing for Orthopaedic Countersink (Class A Medical Device)

As a trusted regulatory consultancy with over 25 years of experience and having supported 500+ companies in obtaining CDSCO licenses, we understand the challenges manufacturers and importers face in India’s medical device market. This detailed guide focuses specifically on the Orthopaedic Countersink, a Class A medical device used as a bone profiler in dental procedures, governed under the notification 29/Misc./03/2020-DC (193)- Part-3 dated 16.03.2022.

Introduction: Orthopaedic Countersink and Regulatory Importance

Orthopaedic Countersinks are precision bone-cutting instruments essential for bone preparation during dental surgeries, enabling proper placement of gingival components. As a Class A device (low risk), it falls under the category of General Hospital or Orthopaedic Instruments. While considered low risk, obtaining the correct CDSCO license is mandatory for manufacturing or importing this device into India to ensure compliance with safety, quality, and performance standards.

CDSCO Regulatory Framework for Orthopaedic Countersink

The Central Drugs Standard Control Organisation (CDSCO) regulates medical devices in India. The Orthopaedic Countersink is classified as a Class A device, which requires a manufacturing license in the form of MD5 License issued by the State Licensing Authority. The regulatory framework mandates submission of technical documentation, a successful product audit, and compliance with quality management systems.

Risk Classification and License Requirements for Orthopaedic Countersink

• Risk Class: A (Low Risk)
• Applicable License: MD5 License (Form MD3 for application, license granted on Form MD5)
• Licensing Authority: State Licensing Authority

The classification aligns with the notification dated 16.03.2022, ensuring clarity on regulatory pathways. For detailed classification criteria, refer to our Medical Device Classification guide.

Manufacturing License Process (MD5 License)

The MD5 license process is comprehensive but straightforward when planned properly. It includes the following key stages:

1. Test License Application (Form MD13): Before applying for a manufacturing license, you must obtain a test license which allows product testing. This typically takes 1.5 to 2 months.

2. Product Testing: Conduct mandatory testing of Orthopaedic Countersink at CDSCO-approved testing laboratories. Testing verifies compliance with relevant standards and specifications.

3. Documentation Preparation: Prepare extensive technical documentation including Device Master File, Plant Master File, Risk Management File, Essential Principles Checklist, and Quality Management System documents.

4. License Application Submission (Form MD3): Submit the complete application for MD5 license through the CDSCO MD Online Portal.

5. Audit by Notified Body: A notified body listed on the CDSCO Notified Bodies List will conduct a thorough audit of your manufacturing facility and documentation.

6. Query Resolution: Address any queries raised by the licensing authority or notified body promptly.

7. Grant of License: Upon satisfactory compliance, the MD5 license is granted, permitting manufacturing of the Orthopaedic Countersink in India.

Manufacturing License Documents Required for Orthopaedic Countersink

To ensure a smooth review process, the following documents must be meticulously prepared and submitted:

• Company Constitution/Registration Certificate
• Proof of Ownership or Lease Agreement of Manufacturing Premises
• Details and Qualification Certificates of Technical Staff
• Fire and Pollution NOCs
• Device Master File (DMF): Detailed design, manufacturing process, and specifications (Device Master File Guide)
• Plant Master File (PMF): Details of manufacturing facility and quality control systems (Plant Master File Guide)
• Essential Principles Checklist
• Risk Management File (Risk Management Guide)
• Test Reports from Government-Approved Labs (Testing Laboratories)
• Product Labels and Instructions for Use (IFU)
• Quality Management System Documentation (ISO 13485:2016 preferred)

Import License Process (MD15 License) for Orthopaedic Countersink

While this guide primarily addresses manufacturing licensing, importers of Orthopaedic Countersinks must apply for an MD15 Import License from the Central Licensing Authority. The process involves:

• Preparing documents such as Manufacturing License from the country of origin, Free Sale Certificate, ISO 13485 certification, CE Certificate, Device and Plant Master Files, Wholesale License, and Company Constitution.
• Submitting application on the CDSCO MD Online Portal using Form MD14.
• Addressing any queries from CDSCO.
• The process typically takes 5-6 months.

For detailed import licensing guidance, review our Import License Guide.

Timeline and Processing Duration

Government Fees and Costs for MD5 License

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

Additional costs may include fees for:

• Testing at approved government laboratories
• Notified body audit fees
• Consultancy and documentation preparation (if outsourced)

Planning your budget upfront helps avoid delays and unexpected expenses.

Common Challenges and Practical Solutions

Challenge: Delays in product testing due to backlog at government labs.

Solution: Schedule testing appointments early and consider alternate CDSCO-approved labs from the Testing Laboratories list.

Challenge: Non-compliance during notified body audit.

Solution: Conduct internal pre-audits and rigorous QMS implementation before scheduling external audits.

Challenge: Incomplete documentation causing application rejection.

Solution: Use comprehensive checklists and expert review to ensure all required documents are accurate and complete.

Expert Consultation and Support

Navigating the CDSCO licensing process for Orthopaedic Countersinks requires detailed knowledge of regulatory nuances and procedural rigor. Our consultancy has successfully supported over 500 manufacturers and importers through:

• End-to-end application management
• Preparation of Device and Plant Master Files
• Risk management and technical file compilation
• Coordination with notified bodies and testing labs
• Post-license compliance and renewals

Contact us for tailored support to accelerate your market entry while ensuring full compliance.

Getting Started with Your CDSCO License Application for Orthopaedic Countersink

1. Confirm Device Classification: Verify that your Orthopaedic Countersink is Class A as per CDSCO notification.
2. Prepare Test License Application: Begin with Form MD13 submission via the CDSCO MD Online Portal.
3. Identify Testing Laboratory: Choose a CDSCO-approved lab from the official list and schedule product testing.
4. Compile Documentation: Develop your Device and Plant Master Files, Risk Management File, and other technical documents.
5. Engage Notified Body Early: Select a notified body from the Notified Bodies List and understand their audit timelines.
6. Submit MD5 License Application: Complete and submit Form MD3 online post successful testing.
7. Prepare for Audit: Ensure your manufacturing facility and QMS are audit-ready.
8. Respond to Queries Promptly: Timely response accelerates license issuance.

Taking these actionable steps will set a solid foundation for obtaining your CDSCO MD5 manufacturing license efficiently. For detailed assistance, download our MD5 License Guide.

By following the above expert recommendations, manufacturers and importers of Orthopaedic Countersinks can confidently navigate the regulatory landscape in India, ensuring compliance, reducing time-to-market, and achieving commercial success.