CDSCO License for Surgical gown (Sterile)

Comprehensive Guide to CDSCO Licensing for Sterile Surgical Gowns (Class B)

As experienced medical device regulatory consultants with over 25 years supporting 500+ companies, we understand the complexities of obtaining CDSCO licenses for devices like sterile surgical gowns. These gowns, classified as Class B under the Personal Protective Equipment category, play a critical role in infection control during surgical procedures. Securing the correct CDSCO license is essential for legal manufacturing and importation into India.

Understanding Surgical Gown (Sterile) and Its Regulatory Importance

Sterile surgical gowns are specialized garments intended to create a barrier against microorganisms, body fluids, and particulates during surgical procedures. Given the direct patient contact and the potential risk of contamination, the Indian regulatory framework classifies sterile surgical gowns as Class B medical devices. This classification mandates compliance with specific quality, safety, and efficacy standards under the CDSCO regime.

CDSCO Regulatory Framework for Class B Medical Devices

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices under the Ministry of Health and Family Welfare. For Class A and B devices like sterile surgical gowns, the licensing authority lies with the State Licensing Authority. The primary manufacturing license applicable is the MD5 License (Application Form MD3), which requires submission through the CDSCO MD Online Portal.

Risk Classification and License Requirements for Sterile Surgical Gowns

• Device: Sterile Surgical Gown
• Risk Class: B (Low to moderate risk)
• License Type: MD5 (Manufacturing License for Class A/B devices)
• Application Form: MD3
• Licensing Authority: State Licensing Authority

Being Class B, manufacturers need to obtain a test license (Form MD13) before applying for the manufacturing license. This ensures the product undergoes mandatory testing in government-approved laboratories.

Manufacturing License Process for MD5

1. Obtain Test License (Form MD13): Initiate by applying for a test license, which typically takes 1.5 to 2 months.
2. Product Testing: Conduct mandatory testing at CDSCO-recognized laboratories. You can find the list of approved testing labs here.
3. Document Preparation: Prepare comprehensive documentation including Device Master File, Plant Master File, Quality Management System (QMS) documents, and risk management files.
4. Apply for Manufacturing License (Form MD3): Submit your MD5 license application through the CDSCO MD Online Portal.
5. Audit by Notified Body: Coordinate with a notified body for the required audit. The list of notified bodies is essential for selecting an auditor.
6. Respond to Queries: Address any queries raised by the licensing authority or notified body promptly.
7. License Grant: Upon satisfactory compliance, the State Licensing Authority will issue the MD5 license.

Manufacturing License Documents Required for Sterile Surgical Gown

• Company Constitution Documents (e.g., Certificate of Incorporation)
• Proof of Ownership or Lease Agreement for Manufacturing Premises
• Details and Qualifications of Technical Staff
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF) – product specifications, design, manufacturing process (Guide here)
• Plant Master File (PMF) – facility details and quality systems (Guide here)
• Essential Principles Compliance Checklist
• Risk Management File (Learn more)
• Test Reports from Government-Approved Labs
• Product Labels and Instructions for Use (IFU)
• Quality Management System Documents (e.g., ISO 13485:2016 Certification)

Import License Process for Sterile Surgical Gown (If Applicable)

Importers must obtain the MD15 License granted by the Central Licensing Authority before importing sterile surgical gowns:

1. Document Preparation: Compile relevant documents including manufacturing license, Free Sale Certificate, CE certificate (if applicable), QMS certificates, Device Master File, and Plant Master File.
2. Apply Using Form MD14: Submit the MD15 license application through the CDSCO MD Online Portal.
3. Query Resolution: Respond to any authority queries promptly.
4. License Issuance: The license is typically granted within 5-6 months.

Import License Documents Required

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

Timeline and Processing Duration

Government Fees and Costs

• MD5 License:
  • Rs. 5,000 per application
  • Rs. 500 per product
• Test License (MD13): No separate fee but mandatory step
• Import License (MD15):
  • Class B: Rs. 1,50,000 per site + Rs. 75,000 per product (approximate USD amounts converted)

Common Challenges and Practical Solutions

• Delays in Testing: Government labs may have backlogs; consider pre-planning and early application for test licenses.
• Incomplete Documentation: Ensure Device Master File and Plant Master File are detailed and aligned with CDSCO expectations.
• Audit Non-Compliance: Prepare thoroughly for notified body audits by conducting internal audits beforehand.
• Queries and Rejections: Respond promptly and provide clear, comprehensive explanations to avoid extended delays.

Expert Consultation and Support

Navigating CDSCO licensing can be complex, but with expert guidance, you can streamline the process effectively. We offer tailored support including:

• Preparation and review of Device Master Files and Plant Master Files
• Coordination with notified bodies and test labs
• Application filing and follow-up through the CDSCO MD Online Portal
• Training on compliance with Essential Principles and risk management

Getting Started with Your CDSCO License Application for Sterile Surgical Gowns

1. Assess Your Device Classification: Confirm your device is Class B and understand the specific licensing pathway.
2. Prepare Test License Application: Submit Form MD13 through the CDSCO MD Online Portal to initiate testing.
3. Engage Testing Laboratories: Schedule product testing at CDSCO-approved labs to prevent delays.
4. Compile Required Documentation: Begin preparing Device and Plant Master Files, risk files, and QMS documentation.
5. Select Notified Body for Audit: Choose from the list of notified bodies and schedule your audit.
6. Submit Manufacturing License Application: Once testing and document preparation are complete, apply for the MD5 license on the CDSCO portal.
7. Monitor and Respond: Stay proactive in resolving queries and preparing for the audit.

By following these actionable steps and leveraging professional expertise, manufacturers and importers of sterile surgical gowns can efficiently navigate CDSCO licensing, ensuring compliance and timely market entry in India.

For more detailed guidance, consult our MD5 License Guide or contact our regulatory experts.