CDSCO License for Non-sterile Surgical file

Introduction to Non-sterile Surgical File and Regulatory Importance

Non-sterile surgical files are essential hand-held instruments used in operation theatres to smooth, grind, or sever tissues during surgeries. Despite their seemingly simple design, these devices require stringent regulatory compliance before entering the Indian market to ensure patient safety and quality standards. With the Central Drugs Standard Control Organization (CDSCO) overseeing medical device licenses, manufacturers and importers must navigate a detailed process to obtain the appropriate approvals.

As experts with over 25 years of experience and having supported 500+ companies secure CDSCO licenses, we understand the nuances involved in licensing Class A devices like the non-sterile surgical file. This guide provides you with comprehensive, actionable insights to streamline your regulatory journey.

CDSCO Regulatory Framework for Non-sterile Surgical Files

The regulatory governance of medical devices in India falls under the Medical Device Rules (MDR) 2017, notified by CDSCO. Non-sterile surgical files are categorized under Class A—low-risk devices. Compliance involves meeting quality management systems, safety standards, and obtaining manufacturing or import licenses as applicable.

Your device, notified under File No. 29/Misc/03/2020-DC (199) on 13.9.2021, must adhere to these regulations to ensure lawful marketing and distribution in India.

Risk Classification and License Requirements

The non-sterile surgical file is classified as a Class A device due to its manual operation and low-risk profile. According to CDSCO:

• Class A and B devices require a Manufacturing License (MD5) if made in India.
• For importers, an Import License (MD15) from CDSCO Central Licensing Authority is mandatory.

This classification mandates a state-level licensing authority for manufacturing and central authority for imports.

Learn more about medical device classification here.

Manufacturing License Process (MD5) for Non-sterile Surgical Files

For manufacturers of non-sterile surgical files, the MD5 license is essential. The process includes:

1. Test License (Form MD13): Apply for a test license to manufacture the device for testing purposes; takes approximately 1.5 to 2 months.
2. Product Testing: Conduct product testing at CDSCO-approved laboratories to verify compliance with essential principles.
3. Documentation Preparation: Compile required documents including Device Master File and Plant Master File.
4. Application Submission (Form MD3): File the manufacturing license application via the CDSCO MD Online Portal.
5. Audit: Undergo an audit by a notified body listed here.
6. Queries Resolution: Address any queries raised by the CDSCO or notified body promptly.
7. License Grant (Form MD5): Upon successful completion, the manufacturing license is granted.

Total duration for the entire process is approximately 3 to 4 months.

For detailed guidance, refer to our MD5 License Guide.

Manufacturing License Documents Required

Successful MD5 license applications require comprehensive documentation:

• Company Constitution or Incorporation Certificate
• Proof of Ownership/Lease of Manufacturing Premises
• Details and Qualifications of Technical Staff
• Fire NOC and Pollution Control NOC
• Device Master File (DMF) – covering design, manufacturing process, and specifications. Our Device Master File guide can help prepare this.
• Plant Master File (PMF) – details about the manufacturing facility, quality control, and equipment. Check our Plant Master File Guide.
• Essential Principles Checklist demonstrating adherence to safety and performance standards
• Risk Management File specific to non-sterile surgical files, documenting hazard identification and mitigation. Learn more about risk management.
• Test Reports from CDSCO-approved testing laboratories, which can be found here
• Device Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documents, preferably ISO 13485:2016 certification

Ensuring all these are complete and accurate reduces delays significantly.

Import License Process (MD15) for Non-sterile Surgical Files

For importers, the MD15 license is mandatory and is granted by the Central Licensing Authority. The process is as follows:

1. Document Compilation: Prepare all required documents including manufacturing license from the country of origin.
2. Application Submission (Form MD14): Submit your application via the CDSCO MD Online Portal.
3. Queries Resolution: Address any departmental queries diligently.
4. License Grant (Form MD15): Receive import license after successful review.

No test license is required for imports. The process typically takes 5 to 6 months.

Import License Documents Required

Key documents for MD15 import license include:

• Valid Manufacturing License from the country of origin
• Free Sale Certificate
• ISO 13485:2016 Certification
• CE Certificate (if applicable)
• Device Master File
• Plant Master File
• Wholesale License
• Company Constitution

Costs vary based on device class; for Class A devices, expect fees around $1000 per site and$50 per product.

For more details, check our Import License Guide.

Timeline and Processing Duration

Planning your application with realistic timelines ensures smooth project management.

Government Fees and Costs

• MD5 License (Class A device):

  • Application Fee: Rs 5,000
  • Per Product Fee: Rs 500

• MD15 Import License (Class A device):

  • Site Fee: $1,000
  • Per Product Fee: $50

Budgeting for these fees early helps avoid surprises.

Common Challenges and Solutions

• Incomplete Documentation: Missing files like Device Master File or Risk Management File cause delays. Solution: Use comprehensive checklists and expert reviews.
• Audit Non-compliance: Not meeting notified body requirements can lead to rejection. Solution: Conduct pre-audit internal inspections.
• Testing Delays: Government-approved labs often have backlogs. Solution: Schedule tests early and consider contingency labs.
• Query Management: Slow responses increase processing time. Solution: Assign dedicated regulatory personnel for timely replies.

Our experience suggests that proactive preparation and clear communication with CDSCO and notified bodies reduce hurdles significantly.

Expert Consultation and Support

Navigating CDSCO regulations can be complex, especially for first-time applicants. We offer:

• End-to-end license application management
• Document preparation and review
• Audit readiness support
• Liaison with CDSCO and notified bodies

Our track record with 500+ successful licenses for Class A devices like non-sterile surgical files demonstrates our commitment to your success.

Getting Started with Your CDSCO License Application

1. Assess Your Product Classification and Licensing Needs: Confirm your device is Class A and requires an MD5 manufacturing license.
2. Prepare Required Documents: Start compiling your Device Master File, Plant Master File, and QMS documents.
3. Apply for Test License (MD13): Initiate the test license application on the CDSCO MD Online Portal.
4. Plan Testing and Audit: Schedule product testing at CDSCO-approved labs and select a notified body for audit.
5. Submit Manufacturing License Application (MD3): Once test license and testing are complete, file the MD5 license application.
6. Respond Promptly to Queries: Ensure designated regulatory teams handle any follow-up efficiently.

Starting early and partnering with experienced consultants can decrease your time-to-market and ensure compliance confidence. Contact us to leverage our expertise for your non-sterile surgical file CDSCO licensing journey.