CDSCO License for Sterile Surgical file

Comprehensive Guide to CDSCO Licensing for Sterile Surgical Files (Class B Medical Device)

Sterile surgical files play a critical role in surgical procedures by enabling surgeons to smooth, grind, or sever tissues manually with precision. Classified as a Class B medical device under the Indian regulatory framework, these hand-held instruments fall under the operation theatre category, requiring a thorough and compliant licensing process before market entry.

With over 25 years of experience and assisting more than 500 companies in navigating India's CDSCO regulatory landscape, we provide you a detailed roadmap to successfully obtain your manufacturing or import license for sterile surgical files.

CDSCO Regulatory Framework for Sterile Surgical Files

The Central Drugs Standard Control Organization (CDSCO) governs medical device regulations in India. Since the notification dated 13.9.2021 (File No. 29/Misc/03/2020-DC (199)), sterile surgical files are regulated under the Medical Device Rules, 2017, as amended.

Classified as Class B devices, they require compliance with specific quality and safety standards, including adherence to essential principles, risk management, and quality management systems (QMS).

Manufacturers must obtain a manufacturing license (MD5), while importers require an import license (MD15) for legal marketing.

Risk Classification and License Requirements for Class B Devices

Sterile surgical files are categorized as Class B, which denotes low to moderate risk. Accordingly, the license requirements and regulatory processes are as follows:

• Manufacturing License: MD5 License (Application Form MD3)
• Regulatory Authority: State Licensing Authority
• Typical Processing Time: 3-4 months including test license and audit
• Fees: ₹5,000 per application + ₹500 per product

The entire process includes obtaining a test license (Form MD13), product testing, audit by notified bodies, and finally grant of the MD5 license.

Manufacturing License Process (MD5) for Sterile Surgical Files

1. Apply for Test License (Form MD13): Before manufacturing, apply for a test license which takes approximately 1.5 to 2 months to be granted.
2. Product Testing: Conduct mandatory product testing at CDSCO-approved government laboratories. You can find the updated list of testing laboratories for this purpose.
3. Document Preparation: Prepare essential documentation including Device Master File (DMF), Plant Master File (PMF), Risk Management File, and Quality Management System (QMS) documentation.
4. Submit Manufacturing License Application (Form MD3): File your application through the CDSCO MD Online Portal.
5. Audit by Notified Body: An audit is conducted by a notified body listed on the CDSCO Notified Bodies List.
6. Query Resolution: Respond promptly to any queries raised by the department or notified body.
7. License Grant: Upon satisfactory compliance, the MD5 license will be granted in Form MD5.

For a step-by-step walkthrough, our detailed MD5 License Guide provides extensive insights.

Manufacturing License Documents Required for Sterile Surgical Files

The documentation package is critical for a smooth licensing process. Required documents include:

• Company Constitution (Memorandum & Articles of Association)
• Proof of Ownership or Lease of Manufacturing Premises
• Details and Qualification Certificates of Technical Staff
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF) detailing design, composition, and manufacturing process (See our DMF Guide)
• Plant Master File (PMF) describing the manufacturing facility and processes (Learn more here)
• Essential Principles Compliance Checklist
• Risk Management File demonstrating hazard analysis and risk control measures (Risk Management Insights)
• Test Reports from CDSCO-approved labs
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documents, usually ISO 13485:2016 certification

Import License Process (MD15) for Sterile Surgical Files

For importers, the MD15 import license is necessary and is granted by the Central Licensing Authority.

Key points:

• Application Form: MD14
• Processing Time: Approximately 5-6 months
• Fees: Varies by device class; for Class B devices, fees are ₹50,000 per site + ₹1,000 per product
• Documents Required: Manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate (if applicable), Device and Plant Master Files, Wholesale License, and Company Constitution.

Documentation should be submitted via the CDSCO MD Online Portal, and any queries must be addressed promptly to avoid delays.

Our comprehensive Import License Guide covers all import-specific nuances.

Timeline and Processing Duration

Planning your timeline with buffer periods for unexpected queries or additional testing can streamline the process.

Government Fees and Costs Breakdown

Additional costs may include laboratory testing fees (varies by test), audit fees charged by notified bodies, and consultancy fees if you engage external experts.

Common Challenges and Practical Solutions

• Incomplete Documentation: Many manufacturers face delays due to missing or incomplete technical files. Proactively preparing a detailed Device Master File and Plant Master File is essential.

• Audit Non-Compliance: Ensuring your QMS and manufacturing facility comply with ISO 13485:2016 standards significantly reduces audit findings.

• Delayed Testing: Scheduling product testing early in the process and selecting CDSCO-approved labs from the official list can prevent bottlenecks.

• Query Response Time: Assign a dedicated regulatory lead to respond promptly to CDSCO queries, as delays directly extend the approval timeline.

• Labeling and IFU Issues: Labels and Instructions for Use must comply with CDSCO’s essential principles including language, content, and safety warnings.

Expert Consultation and Support

Navigating CDSCO licensing for sterile surgical files can be complex. Our proven track record with over 500 successful approvals means we understand the nuances and can guide you through every step—from documentation preparation to audit readiness.

We offer:

• Customized regulatory strategy
• Comprehensive document preparation
• Coordination with notified bodies and testing labs
• Training on compliance and QMS enhancement

Partnering with experienced consultants can drastically reduce approval times and avoid costly rejections.

Getting Started with Your CDSCO License Application for Sterile Surgical Files

1. Assess Your Device Classification: Confirm your device is Class B using the Medical Device Classification tool.
2. Prepare Test License Application: Submit Form MD13 via the CDSCO MD Online Portal to begin the process.
3. Compile Required Documents: Start assembling your Device Master File, Plant Master File, and QMS certificates.
4. Schedule Product Testing: Contact a CDSCO-approved testing laboratory early to arrange testing timelines.
5. Engage a Notified Body: Identify and appoint a notified body for the mandatory audit.
6. Submit Manufacturing License Application (MD3): Once test license is granted and test reports are ready, apply for the MD5 license.
7. Prepare for Audit and Queries: Ensure your facility and documentation are audit-ready and respond quickly to any CDSCO queries.

By following these structured steps, manufacturers and importers of sterile surgical files can confidently secure their CDSCO license and successfully launch their products in the Indian market.

For more detailed assistance, feel free to connect with our expert team who specialize in medical device regulatory compliance.