CDSCO License for Surgical Elevator

Introduction to Surgical Elevator and Its Regulatory Importance

Surgical Elevators are essential handheld instruments widely used in general hospital and orthopaedic settings. Characterized by their long flat metal design with blunt or hooked ends, they assist surgeons in lifting organs or tissues during complex procedures. Given their direct application in invasive interventions, these devices are classified under Risk Class A by the Central Drugs Standard Control Organization (CDSCO) in India. Compliance with CDSCO regulations is crucial for manufacturers and importers to ensure safety, efficacy, and legal market access.

At our consultancy, leveraging over 25 years of experience and assisting 500+ companies, we understand the nuances of obtaining a CDSCO license for Class A devices like Surgical Elevators. This guide provides detailed, practical insights into the regulatory framework, documentation, timelines, and costs involved.

CDSCO Regulatory Framework for Surgical Elevators

The CDSCO governs medical device approval under the Medical Device Rules, 2017 (MDR 2017), amended periodically. Surgical Elevators fall under Class A (low risk) as per the notification 29/Misc./03/2020-DC (193)- Part-3 dated 16.03.2022. This classification mandates obtaining a manufacturing license (MD5) from the State Licensing Authority before market entry.

To maintain compliance, manufacturers must follow a structured process involving product testing, documentation, audit, and final license issuance via the centralized CDSCO MD Online Portal.

Risk Classification and License Requirements for Surgical Elevators

• Device Risk Class: A (Low Risk)
• Applicable License: MD5 Manufacturing License
• Issuing Authority: State Licensing Authority
• Application Form: MD3 for license application; MD13 for test license
• Total Processing Time: Approximately 3-4 months
• Fees: Rs 5,000 per application + Rs 500 per product

Class A devices like Surgical Elevators require a test license to conduct necessary product testing in CDSCO-approved labs before applying for the MD5 license.

Manufacturing License Process (MD5) for Surgical Elevators

1. Apply for Test License on Form MD13: Initiate the process by applying for a test license which allows product testing in government-recognized laboratories. This stage typically takes 1.5 to 2 months.
2. Product Testing: Submit Surgical Elevator samples to a CDSCO-approved Testing Laboratory. Testing ensures compliance with applicable Indian standards and safety norms.
3. Preparation of Documentation: Concurrently prepare required documents such as Device Master File, Plant Master File, Quality Management System (QMS) records, and risk management files.
4. Application for MD5 License (Form MD3): After successful testing, submit the license application through the CDSCO MD Online Portal for State Licensing Authority approval.
5. Audit by Notified Body: A mandatory audit by a notified body listed under CDSCO Notified Bodies List is conducted to verify compliance with MDR 2017 requirements.
6. Query Resolution: Address any queries raised by CDSCO or the notified body promptly.
7. Grant of MD5 License: Upon satisfactory audit and document verification, the State Licensing Authority issues the license on Form MD5.

Manufacturing License Documents Required for Surgical Elevators

• Company constitution and registration certificates
• Proof of ownership or lease agreement of manufacturing premises
• Details of technical staff with qualifications
• Fire safety and pollution control clearances (No Objection Certificates)
• Device Master File (DMF) outlining product specifications, manufacturing processes, and controls (Device Master File Guide)
• Plant Master File (PMF) detailing manufacturing facility infrastructure and quality assurance procedures (Plant Master File Guide)
• Essential Principles Checklist confirming device compliance with regulatory safety and performance criteria
• Risk Management File demonstrating hazard identification, risk analysis, and mitigation strategies (Risk Management)
• Product test reports from CDSCO-approved labs
• Product labels and Instructions for Use (IFU) in English and regional languages
• Quality Management System documentation, typically ISO 13485:2016 certification

Import License Process (MD15) for Surgical Elevators

While Surgical Elevators are primarily manufactured domestically to reduce regulatory complexity, importers must obtain an MD15 import license granted by the Central Licensing Authority.

The process for import license includes:

• Document preparation including manufacturing license from the country of origin, Free Sale Certificate, CE certificate, and ISO 13485:2016
• Submission of application using Form MD14 via the CDSCO MD Online Portal
• Review and query resolution
• Grant of import license on Form MD15

The import license timeline ranges from 5-6 months, with fees varying by device class.

Import License Documents Required

• Valid manufacturing license of the foreign manufacturer
• Free Sale Certificate from the country of origin
• ISO 13485:2016 QMS certificate
• CE Certificate or equivalent regulatory approval
• Device Master File and Plant Master File
• Wholesale license for importers
• Company constitution and address proof

Timeline and Processing Duration for Surgical Elevator Licensing

Planning for at least 4 months ensures a buffer for unforeseen delays.

Government Fees and Costs for MD5 License

• Application fee: Rs 5,000 per application
• Product fee: Rs 500 per product (Surgical Elevator counts as one product)

Additional costs may include fees for testing services, notified body audits (which vary by body), and consultant fees if external help is engaged.

Common Challenges and Solutions

Challenge 1: Delays in Product Testing

• Solution: Engage early with CDSCO-approved labs and submit samples promptly. Confirm testing scope and timelines upfront.

Challenge 2: Incomplete Documentation

• Solution: Utilize detailed checklists like our Device Master File guide and Plant Master File guide to ensure completeness.

Challenge 3: Audit Non-Compliance

• Solution: Pre-audit your facility using notified body criteria available in the Notified Bodies List and maintain robust QMS documentation.

Challenge 4: Query Response Delays

• Solution: Assign a dedicated regulatory liaison to monitor CDSCO communications and respond swiftly.

Expert Consultation and Support

Our team has successfully guided 500+ medical device companies through the CDSCO licensing maze. We offer tailored consultancy including gap analysis, document preparation, liaison with notified bodies, and audit readiness training. With deep insights into Surgical Elevator classification and compliance, we streamline your approval journey.

Getting Started with Your CDSCO License Application for Surgical Elevators

1. Assess Device Classification: Confirm your Surgical Elevator as Class A using the official Medical Device Classification resources.
2. Register on CDSCO MD Online Portal: Begin by creating your account and familiarizing yourself with the portal workflows.
3. Prepare Test License Application: Assemble initial documents and apply for the test license (MD13).
4. Engage with Testing Labs: Coordinate product sample submission to CDSCO-approved labs.
5. Compile Comprehensive Documentation: Leverage our guides to develop Device Master File, Plant Master File, and risk management files.
6. Schedule Notified Body Audit: Select a notified body from the CDSCO Notified Bodies List and prepare for audit.
7. Submit MD5 License Application: Post testing and audit, submit your MD5 application (Form MD3) via the portal.
8. Maintain Proactive Communication: Track application status and respond swiftly to queries.

By following these actionable steps, manufacturers and importers can confidently navigate the CDSCO regulatory landscape for Surgical Elevators, ensuring timely market access and compliance assurance.

For further expert assistance, reach out to our team to discuss your specific requirements and receive personalized regulatory support.