CDSCO License for Surgical Trays

Comprehensive Guide to CDSCO Licensing for Surgical Trays (Class A Medical Device)

Surgical trays play an indispensable role in clinical and surgical environments as containers designed to hold and organize various medical instruments during procedures. Classified as Class A devices under the CDSCO framework, surgical trays are non-invasive, reusable devices often used for both clinical application and sterilization processes. Navigating the regulatory landscape for these devices is crucial for manufacturers and importers aiming to enter the Indian healthcare market. With over 25 years of experience and having supported 500+ companies, we offer you an in-depth, practical roadmap tailored specifically for Surgical Trays.

CDSCO Regulatory Framework for Surgical Trays

In India, the Central Drugs Standard Control Organization (CDSCO) regulates medical devices under the Medical Device Rules, 2017. Surgical trays fall under Class A, the lowest risk category, but regulatory compliance remains mandatory. The governing notification for these trays is 29/Misc./03/2020-DC (193)- Part-3, dated 16.03.2022, which clarifies classification and conformity requirements.

Manufacturers of Class A devices must obtain an MD5 manufacturing license issued by the State Licensing Authority. This ensures that the manufacturing process, quality management systems, and device safety comply with Indian regulations.

Risk Classification and License Requirements for Surgical Trays

Surgical trays are classified as Class A, indicating low risk. This classification impacts the licensing pathway:

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

For a detailed explanation of medical device classification, refer to our Medical Device Classification guide.

Manufacturing License Process for Surgical Trays (MD5 License)

The MD5 license process is comprehensive and involves several sequential steps:

1. Test License (Form MD13): Before applying for MD5, manufacturers must obtain a test license valid for 6 months. This allows sample production and testing.
2. Product Testing: Conduct mandatory testing at CDSCO-approved laboratories to verify compliance with Indian standards. You can consult the list of Testing Laboratories.
3. Document Preparation: Compile a robust dossier including technical and quality documents.
4. Application Submission: Submit your MD5 application via the CDSCO MD Online Portal using Form MD3.
5. Audit by Notified Body: A designated notified body conducts an on-site audit focusing on manufacturing processes and quality management. View the list of notified bodies.
6. Query Resolution: Address any queries or observations raised by CDSCO or the notified body promptly.
7. Grant of License: Upon satisfactory review, the MD5 license is issued on Form MD5.

Manufacturing License Documents Required for Surgical Trays

Accurate and complete documentation is the cornerstone of a smooth licensing process. For Surgical Trays (Class A), the following are essential:

• Company Constitution (e.g., incorporation certificate)
• Proof of ownership or lease agreement of the manufacturing premises
• Details and qualifications of technical staff
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF): Detailed design, specifications, and manufacturing process. Our Device Master File guide offers practical insights.
• Plant Master File (PMF): Information about the manufacturing facility and quality systems. Learn more in our Plant Master File guide.
• Essential Principles Checklist demonstrating compliance with Indian regulations
• Risk Management File, detailing hazard identification and mitigation strategies. For effective implementation, see our Risk Management guide.
• Test Reports from CDSCO-approved labs
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documentation, preferably ISO 13485 certified

Import License Process for Surgical Trays (Not Applicable for Manufacturers)

For importers, Surgical Trays (Class A) require an MD15 import license granted by the Central Licensing Authority. The process includes:

• Document preparation, including manufacturing license of the exporter, Free Sale Certificate, and ISO 13485:2016 certification
• Application submission on Form MD14 via the CDSCO MD Online Portal
• Query resolution and license grant on Form MD15

Import license processing typically takes 5-6 months, with fees based on device class and quantities. For detailed guidance, refer to our Import License guide.

Timeline and Processing Duration

The typical timeline for securing an MD5 license for Surgical Trays is approximately 3-4 months, broken down as follows:

• Test License (MD13): 1.5 to 2 months
• Product Testing: 2 to 4 weeks, depending on lab workload
• Document Preparation: Concurrent with testing
• Application Submission and Audit Scheduling: 2-4 weeks
• Audit and Query Resolution: 4-6 weeks

Planning for potential delays during audits or document clarifications is prudent. Early engagement with notified bodies and testing labs helps expedite the process.

Government Fees and Costs

The fee structure for MD5 license applications for Surgical Trays is as follows:

• Application fee: Rs. 5,000 per submission
• Product fee: Rs. 500 per product variant

Additional costs may include:

• Testing laboratory fees (variable based on tests required)
• Notified body audit fees (negotiable with respective bodies)
• Consultancy fees if you engage expert support

Budgeting accordingly ensures smooth financial planning.

Common Challenges and Solutions

Challenge 1: Delays in Product Testing

• Solution: Schedule testing well in advance and select laboratories with shorter lead times from the CDSCO-approved list.

Challenge 2: Incomplete Documentation Leading to Queries

• Solution: Use comprehensive checklists and templates for DMF and PMF preparation. Our guides provide structured approaches.

Challenge 3: Audit Non-Conformities

• Solution: Prepare thoroughly for audits by conducting internal mock audits and ensuring QMS compliance.

Challenge 4: Understanding Regulatory Updates

• Solution: Stay updated with CDSCO notifications and circulars available on their official portal.

Expert Consultation and Support

Navigating CDSCO licensing can be complex, especially for first-time applicants. With our extensive experience in assisting over 500 companies, we offer tailored consultancy services including:

• Gap analysis of your current compliance status
• Document preparation and review
• Liaison with CDSCO and notified bodies
• Training for your technical and regulatory teams

Our proactive approach minimizes delays and maximizes your chances of timely license approval.

Getting Started with Your CDSCO License Application for Surgical Trays

1. Assess your product classification: Confirm your device as Class A surgical trays using CDSCO guidelines.
2. Engage a CDSCO-approved testing laboratory: Initiate the product testing process early.
3. Prepare Device and Plant Master Files: Use our linked guides for comprehensive preparation.
4. Apply for the Test License (Form MD13): Submit via the CDSCO MD Online Portal.
5. Coordinate with a Notified Body for Audit: Choose from the official notified bodies list.
6. Compile and submit the MD5 application (Form MD3): Ensure all documents are complete and accurate.
7. Respond promptly to queries: Timely responses help maintain processing momentum.

Starting with a clear roadmap and expert support will position your Surgical Tray manufacturing or importing venture for success in India’s regulated medical device market.