CDSCO License for Operating Room Shoes Cover

Comprehensive Guide to CDSCO Licensing for Operating Room Shoes Cover (Class A Medical Device)

Operating Room Shoes Covers are critical personal protective equipment designed to shield the feet of surgical personnel and patients from contamination by microorganisms, body fluids, and particulate matter during surgical procedures. Given their direct role in infection control within healthcare settings, these devices are regulated under India’s Central Drugs Standard Control Organization (CDSCO) framework to ensure safety and efficacy.

CDSCO Regulatory Framework for Operating Room Shoes Cover

Operating Room Shoes Covers fall under Class A medical devices, classified as low-risk under the CDSCO medical device regulations per the notification File No. 29/Misc./03/2020-DC (186), dated 13.9.2021. As a Class A device, regulatory oversight is primarily managed by the State Licensing Authority through the MD5 license process. This classification ensures manufacturers meet essential quality and safety standards before market entry.

Risk Classification and License Requirements for Class A Devices

Class A devices like Operating Room Shoes Cover require an MD5 manufacturing license granted by the State Licensing Authority. This license verifies compliance with manufacturing practices and quality management systems appropriate for low-risk devices. Importers of Class A devices must obtain the MD15 import license from the Central Licensing Authority.

Understanding this classification is crucial to aligning your documentation and processes with the correct regulatory pathway. For a detailed overview of medical device classifications, visit our Medical Device Classification guide.

Manufacturing License Process for Operating Room Shoes Cover (MD5 License)

Our experience assisting over 500 companies reveals that obtaining an MD5 license generally spans 3-4 months, encompassing several key stages:

1. Test License Application (Form MD13): Submit an application for a test license, which takes approximately 1.5-2 months to be granted by the State Authority. This license allows product testing at CDSCO-recognized labs.

2. Product Testing: Conduct product testing at approved laboratories to verify compliance with applicable standards. Refer to the Testing Laboratories list to identify government-approved facilities.

3. Document Preparation: Compile mandatory documents including Device Master File, Plant Master File, Risk Management File, and Quality Management System (QMS) documentation.

4. License Application Submission (Form MD3): Submit the MD5 license application via the CDSCO MD Online Portal.

5. Audit by Notified Body: Coordinate with a notified body for a manufacturing site audit. Consult the Notified Bodies List to select an authorized auditor.

6. Resolution of Queries: Address any concerns or clarifications raised by the CDSCO or notified body promptly.

7. Grant of License (Form MD5): Upon successful audit and document review, the MD5 manufacturing license is issued.

Manufacturing License Documents Required for Operating Room Shoes Cover

Successful MD5 applications typically include:

• Company Constitution (e.g., Memorandum and Articles of Association)
• Proof of Ownership or Lease Agreement for Manufacturing Premises
• Technical Staff Qualification Certificates
• Fire No Objection Certificate (NOC)
• Pollution Control Board NOC
• Device Master File (DMF): Technical specifications, design documents, manufacturing process details. Our Device Master File guide provides an in-depth walkthrough.
• Plant Master File (PMF): Details on manufacturing environment, equipment, and quality controls. Learn more from our Plant Master File guide.
• Essential Principles Checklist demonstrating compliance with Indian medical device standards
• Risk Management File detailing hazard analysis and mitigation strategies. Our Risk Management resource is highly recommended.
• Valid Test Reports from approved labs
• Labeling and Instructions for Use (IFU) complying with CDSCO requirements
• Quality Management System (QMS) documentation, preferably ISO 13485 certified

Import License Process for Operating Room Shoes Cover (MD15 License)

For importers, the MD15 license is mandatory and issued by the Central Licensing Authority. The process, taking approximately 5-6 months, involves:

• Preparing comprehensive documentation including the manufacturer’s MD5 license, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate (if applicable), and Device & Plant Master Files
• Submitting the application on the CDSCO MD Online Portal
• Responding to any CDSCO queries
• Receiving the MD15 import license

Refer to our detailed Import License Guide for step-by-step assistance.

Import License Documents Required

• Valid manufacturing license (MD5) from the country of origin
• Free Sale Certificate issued by the regulatory authority of the manufacturing country
• ISO 13485:2016 Certificate
• CE Certificate (if applicable)
• Device Master File and Plant Master File
• Wholesale Drug License (if applicable)
• Company Constitution documents

Timeline and Processing Duration

The import license process (MD15) may take 5-6 months due to central authority processing.

Government Fees and Costs

• MD5 Manufacturing License: Rs 5,000 per application + Rs 500 per product
• Test License (MD13): Included within the process, fees vary by state
• Import License (MD15): For Class A devices, fees are approximately $1,000 per site +$50 per product

Budgeting for notified body audits, product testing, and consulting fees is essential. These additional costs vary by service provider and complexity.

Common Challenges and Solutions

• Delayed Document Preparation: Proactively assemble all documents early, leveraging templates and expert guidance.
• Testing Lab Backlogs: Schedule testing promptly with government-approved labs to avoid bottlenecks.
• Audit Non-compliance: Conduct internal pre-audits to ensure all QMS and manufacturing practices meet CDSCO standards.
• Queries from CDSCO: Maintain prompt and clear communication with the authority to resolve issues swiftly.

Expert Consultation and Support

Having guided 500+ companies through CDSCO licensing, we emphasize tailored support:

• Comprehensive gap analysis of your current compliance status
• Customized document preparation assistance
• Coordination with notified bodies and testing laboratories
• Strategic advice on timelines and cost optimization

Our hands-on approach reduces application rejections and accelerates market entry.

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm Operating Room Shoes Cover as Class A.
2. Register on the CDSCO MD Online Portal: Create your company profile and begin application submissions.
3. Initiate Test License Application (MD13): Prepare and submit test license documents.
4. Engage Approved Testing Laboratories: Arrange for product testing early.
5. Compile Required Documents: Utilize our DMF and PMF guides for efficient preparation.
6. Schedule Notified Body Audit: Select from the approved list to plan your audit.
7. Submit MD5 License Application: After testing and audit, apply formally.
8. Monitor Application Status and Respond to Queries: Stay engaged through the portal.

Starting early and engaging expert consultants can dramatically improve your chances of a smooth, timely approval. Contact us today to leverage our 25+ years of regulatory expertise for your Operating Room Shoes Cover CDSCO licensing journey.