CDSCO License for Manual surgical  saw, flexible

Comprehensive CDSCO Licensing Guide for Manual Surgical Saw, Flexible (Class B)

As seasoned regulatory consultants with over 25 years of experience and having successfully facilitated licensing for 500+ medical device companies, we understand the intricacies involved in obtaining CDSCO approvals for specialized devices. This guide focuses on the Manual Surgical Saw, Flexible, a Class B device used in neurology and orthopaedics for precise bone cutting during surgery. Navigating the CDSCO regulatory framework efficiently can save you time, money, and ensure market compliance.

Understanding the Device and Its Regulatory Significance

The Manual Surgical Saw, Flexible is a critical surgical instrument designed for delicate bone cutting in neurological and orthopaedic procedures. Given its invasive nature and patient safety implications, it falls under Class B risk classification according to CDSCO norms. Regulatory compliance is mandatory to ensure product safety, efficacy, and quality, which ultimately protects healthcare providers and patients.

CDSCO Regulatory Framework for Manual Surgical Saw, Flexible

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices through a structured licensing system. For Class B devices like the Manual Surgical Saw, the applicable manufacturing license is the MD5 License, granted by the State Licensing Authority. Importers require the MD15 License, issued by the Central Licensing Authority.

Manufacturers and importers must comply with the Medical Device Rules, 2017, which outline risk classification, technical requirements, and documentation standards.

Risk Classification and License Requirements

• Risk Class: B (Low to moderate risk)
• License Type for Manufacturing: MD5 License (Application Form MD3)
• License Type for Import: MD15 License (Application Form MD14)
• Regulatory Authority: State Licensing Authority for MD5; Central Licensing Authority for MD15

For a detailed classification overview, consult the Medical Device Classification guide.

Manufacturing License Process (MD5) for Class B Devices

Obtaining an MD5 license involves multiple phased steps:

1. Test License Application (Form MD13): 1.5 to 2 months
2. Product Testing: Conduct testing of the Manual Surgical Saw at government-approved labs, which typically takes 3–4 weeks. Refer to the list of testing laboratories.
3. Documentation Preparation: Device Master File, Plant Master File, Risk Management File, Essential Principles Checklist, and QMS documents.
4. Submission of MD5 License Application (Form MD3) via CDSCO MD Online Portal: Includes uploading all supporting documents.
5. Notified Body Audit: Engage a notified body from the CDSCO Notified Bodies List for audit of facilities and processes.
6. Resolution of Queries: Respond promptly to any departmental or notified body queries.
7. License Grant: Issuance of MD5 license (Form MD5).

The entire process usually spans 3 to 4 months from test license application to final license grant.

Manufacturing License Documents Required for Manual Surgical Saw, Flexible

• Company Constitution (Incorporation Certificate, Memorandum & Articles of Association)
• Proof of Ownership/Lease of Manufacturing Premises
• Qualified Technical Staff Details (Resume and qualifications)
• Fire NOC and Pollution Control NOC
• Device Master File (technical specifications, design, manufacturing process) – see our comprehensive Device Master File guide
• Plant Master File (facility layout, equipment details) – refer to our Plant Master File guide
• Essential Principles Checklist demonstrating compliance with safety and performance standards
• Risk Management File showcasing hazard analysis and mitigation as per Risk Management practices
• Test Reports from approved laboratories
• Product labels, Instructions for Use (IFU)
• Quality Management System Documents (ISO 13485 certification recommended)

Import License Process (MD15) for Manual Surgical Saw, Flexible

For importers, the MD15 license is mandatory and managed by the Central Licensing Authority. The process includes:

1. Document Preparation: Compile manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE certificate (if applicable), Device Master File, Plant Master File, and wholesale license.
2. Application Submission: File Form MD14 on the CDSCO MD Online Portal.
3. Departmental Review and Queries: Address any clarifications raised.
4. License Grant: MD15 license issuance.

The import license process typically takes 5 to 6 months.

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 and Plant Master File
• Wholesale License
• Company Constitution

Timeline and Processing Duration

Government Fees and Costs

• MD5 License Fees: ₹5,000 per application + ₹500 per product
• MD15 License Fees: For Class B devices, approximately $2,000 per site +$1,000 per product

These fees are payable online via the CDSCO portal.

Common Challenges and Solutions

• Delayed Testing Reports: Engage with notified testing labs early and schedule tests promptly.
• Incomplete Documentation: Use comprehensive checklists like Device and Plant Master Files to avoid rejections.
• Audit Non-Compliance: Pre-audit your processes with consultants or notified bodies to ensure readiness.
• Query Resolution Delays: Assign dedicated regulatory personnel to respond swiftly to department queries.

Expert Consultation and Support

With our extensive experience assisting over 500 companies, we offer end-to-end support including:

• Gap analysis of your existing documentation
• Preparation of Device Master and Plant Master Files
• Coordination with notified bodies and testing labs
• Liaison with CDSCO authorities for smooth application processing
• Training your technical staff on regulatory compliance

Getting Started with Your CDSCO License Application

1. Conduct a Gap Assessment: Evaluate your current setup against CDSCO requirements.
2. Prepare Core Documents: Begin with Device Master File and Risk Management File.
3. Apply for Test License (Form MD13): Initiate testing procedures early through the CDSCO MD Online Portal.
4. Engage Notified Bodies: Identify an appropriate notified body from the official list.
5. Plan for Audit: Implement corrective actions ahead of the audit to avoid delays.

Taking these practical steps will streamline your licensing journey for the Manual Surgical Saw, Flexible and position your company for timely market entry in India.

For a detailed walkthrough of the MD5 license application process, please refer to our MD5 License Guide.

Embark on your regulatory journey confidently with expert guidance tailored to your device. Contact us today to discuss your specific requirements and ensure compliance with the latest CDSCO norms.