CDSCO License for Surgical gown (Non-Sterile)

Introduction to Surgical Gown (Non-Sterile) and Regulatory Importance

Surgical gowns, particularly non-sterile variants, play a crucial role in protecting both patients and operating room personnel from cross-contamination during surgical procedures. Classified as Class A medical devices by the Central Drugs Standard Control Organization (CDSCO), these gowns fall under the Personal Protective Equipment (PPE) category, demanding strict adherence to regulatory standards to ensure safety and compliance.

With over 25 years of experience and having assisted more than 500 companies in navigating the CDSCO licensing framework, we understand the nuances involved in securing timely approvals for surgical gowns in India. The official notification for this device type is File No. 29/Misc./03/2020-DC (186), dated 13.9.2021, which outlines the specific regulatory requirements manufacturers and importers must meet.

CDSCO Regulatory Framework for Surgical Gown (Non-Sterile)

The CDSCO regulates medical devices in India through a risk-based classification system. Surgical gowns (non-sterile) are categorized as Class A, the lowest risk class, which simplifies certain aspects of compliance but still mandates robust quality management and documentation.

Regulatory compliance involves obtaining a manufacturing license (MD5) for domestic manufacturers or an import license (MD15) for importers. Both pathways ensure that the surgical gowns meet essential safety and performance standards defined by the CDSCO.

Risk Classification and License Requirements

As a Class A device, the surgical gown (non-sterile) requires an MD5 manufacturing license. This license is granted by the State Licensing Authority and includes a comprehensive process involving product testing, documentation, and an audit by a notified body. For manufacturers, the process typically spans 3 to 4 months.

For importers, the MD15 import license is mandatory, granted by the Central Licensing Authority, with a longer processing timeline of approximately 5 to 6 months.

To verify your device classification and related requirements, refer to the Medical Device Classification guide.

Manufacturing License Process (MD5) for Class A Surgical Gown

The MD5 manufacturing license process comprises several critical steps:

1. Apply for Test License (Form MD13): This preliminary license allows product testing and takes about 1.5 to 2 months to obtain.
2. Product Testing: Testing must be conducted at CDSCO-approved laboratories. For surgical gowns, tests typically include material strength, microbial penetration, and fabric quality. You can find the list of authorized labs on the CDSCO Testing Laboratories page.
3. Document Preparation: Prepare comprehensive documentation including Device Master File, Plant Master File, Risk Management File, and QMS documents.
4. Application Submission (Form MD3): Submit the MD5 license application through the CDSCO MD Online Portal.
5. Audit by Notified Body: A notified body will conduct a facility audit. Refer to the list of notified bodies to select an accredited auditor.
6. Query Resolution: Address any queries from the CDSCO or notified body promptly.
7. License Grant: Upon satisfactory compliance, the license is issued on Form MD5.

For detailed insights, our MD5 License Guide provides step-by-step assistance.

Manufacturing License Documents Required for Surgical Gown (Non-Sterile)

The following documents are mandatory to support your MD5 application:

• Constitution of the company (incorporation certificate, partnership deed, etc.)
• Proof of ownership or lease agreement of manufacturing premises
• Technical staff qualifications and experience certificates
• Fire NOC and Pollution Control Board NOC
• Device Master File detailing product specifications and manufacturing processes (Device Master File Guide)
• Plant Master File outlining facility details (Plant Master File Guide)
• Essential Principles Checklist confirming compliance with safety and performance
• Risk Management File documenting hazard analysis and mitigation (Risk Management)
• Test reports from government-approved laboratories
• Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documentation, preferably ISO 13485 compliant

Ensuring accuracy and completeness in documentation can significantly reduce processing delays.

Import License Process (MD15) for Surgical Gown (Non-Sterile)

For importers intending to bring surgical gowns into India, obtaining an MD15 import license is essential. The process is as follows:

1. Document Compilation: Prepare required documents including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE certificate, Device and Plant Master Files, and wholesale license.
2. Application Submission: Submit the application on the CDSCO MD Online Portal via Form MD14.
3. Department Review and Queries: The CDSCO reviews the application and raises queries if necessary.
4. License Issuance: Once all requirements are satisfactorily met, the MD15 license is granted.

The import license process typically takes 5 to 6 months. For comprehensive assistance, refer to our Import License Guide.

Import License Documents Required for Surgical Gown

Key documents for MD15 application include:

• Valid manufacturing license from the exporting country
• Free Sale Certificate or equivalent
• ISO 13485:2016 certificate
• CE certificate or other relevant international approvals
• Device Master File and Plant Master File
• Wholesale license
• Constitution of the importing company

Providing complete and verifiable documents expedites the approval process.

Timeline and Processing Duration

Understanding these timelines helps manufacturers and importers plan production and distribution strategies effectively.

Government Fees and Costs

• MD5 License: Application fee of Rs. 5,000 plus Rs. 500 per product.
• MD15 License: Fees vary by device class; for Class A devices, approximately $1000 per site and$50 per product.

Note that additional costs include testing fees at government-approved labs and audit charges by notified bodies.

Common Challenges and Solutions

• Delayed Test Reports: Engage accredited labs early and schedule testing promptly.
• Incomplete Documentation: Use detailed checklists and expert review to ensure completeness.
• Audit Non-Conformities: Conduct internal pre-audits to identify gaps before official inspections.
• Query Management: Respond to CDSCO queries comprehensively and within stipulated timelines.

Our extensive experience enables us to anticipate and mitigate such challenges effectively.

Expert Consultation and Support

Navigating CDSCO licensing for surgical gowns can be complex. Leveraging our 25+ years of expertise, we offer end-to-end support—from documentation preparation to audit coordination. Our proven track record with 500+ companies ensures you receive practical, customized guidance tailored to your product and business model.

Getting Started with Your CDSCO License Application

To initiate your CDSCO licensing journey for surgical gowns (non-sterile), follow these practical steps:

1. Assess Your Product Classification: Confirm Class A status via CDSCO classification resources.
2. Prepare Preliminary Documents: Compile company constitution, premises documents, and technical staff qualifications.
3. Apply for Test License (MD13): Submit through the CDSCO MD Online Portal to start product testing.
4. Coordinate Product Testing: Engage authorized testing laboratories early to avoid delays.
5. Develop Comprehensive Documentation: Focus on Device Master and Plant Master Files, Risk Management, and QMS compliance.
6. Select a Notified Body: Choose an accredited notified body for audits from the official list.
7. Submit MD5 Application (Form MD3): Ensure all documents and test reports are complete.
8. Prepare for Audit: Conduct internal reviews and address potential compliance gaps.
9. Manage Queries Promptly: Maintain open communication channels with CDSCO and auditors.

Embarking on this structured approach will streamline your licensing process, reduce delays, and position your surgical gowns successfully in the Indian market.

For personalized assistance or to discuss your specific requirements, feel free to connect with us. Our expert team is ready to guide you every step of the way.