CDSCO License for Isolation Gown) ( Sterile)
Medical Device Information
Intended Use
A sterile garment made of natural and/or synthetic materials intended to be worn by healthcare providers or visitors to isolate themselves from patients to protect the themselves from a contagious agent which has infected the patient.
Comprehensive Guide to CDSCO Licensing for Sterile Isolation Gowns (Class B)
Isolation gowns (sterile) are critical personal protective equipment (PPE) designed to protect healthcare providers and visitors from contagious agents. Given their vital role in infection control, these gowns fall under Class B medical devices in India and require strict regulatory compliance before market entry. With over 25 years of experience supporting 500+ manufacturers and importers, we provide detailed, practical guidance for obtaining your CDSCO license efficiently.
CDSCO Regulatory Framework for Sterile Isolation Gowns
The Central Drugs Standard Control Organization (CDSCO) governs medical device regulation in India, ensuring safety and efficacy. Since isolation gowns are categorized as Class B devices under the Medical Device Rules 2017, manufacturers must comply with specific licensing protocols before production or import.
The device is notified under File No. 29/Misc./03/2020-DC (186) dated 13.9.2021, which aligns it with other PPE devices regulated as Class B.
Risk Classification and License Requirements
Isolation gowns (sterile) are classified as Class B devices due to their moderate risk profile. This classification mandates obtaining an MD5 license for manufacturing and an MD15 license for import. The MD5 license is issued by the State Licensing Authority and involves:
- Test license acquisition (Form MD13)
- Product testing at CDSCO-recognized labs
- Notified body audit
Understanding these requirements upfront helps avoid costly delays.
Manufacturing License Process (MD5) for Isolation Gowns
The MD5 license application follows a multi-step process:
- Apply for a Test License (Form MD13): This initial step allows you to manufacture samples for testing. Processing time is approximately 1.5 to 2 months.
- Product Testing: Conduct mandatory testing at government-approved laboratories. For isolation gowns, tests typically include sterility, fabric integrity, and barrier performance. Refer to the list of testing laboratories recognized by CDSCO.
- Document Preparation: Prepare detailed technical documentation, including Device Master File, Plant Master File, Risk Management File, and Essential Principles Checklist.
- Submit Application (Form MD3): File your complete MD5 application on the CDSCO MD Online Portal.
- Notified Body Audit: Arrange and complete an audit by a CDSCO-recognized notified body. For Class B devices like sterile isolation gowns, this is mandatory. You can find the list of notified bodies here.
- Query Resolution: Address any observations or queries raised by the licensing authority or notified body.
- Grant of License (Form MD5): Once all requirements are met, the license is granted.
Manufacturing License Documents Required
Accurate documentation is crucial to avoid delays. For sterile isolation gowns, prepare the following:
- Company Constitution Documents (e.g., Incorporation Certificate)
- Proof of Ownership/Lease Agreement of Manufacturing Premises
- Details and Qualifications of Technical Staff
- Fire and Pollution No-Objection Certificates (NOCs)
- Device Master File (DMF): Comprehensive information about the gown’s design, materials, and manufacturing process. Our Device Master File guide provides valuable insights.
- Plant Master File (PMF): Details of your manufacturing facility. Learn how to create an effective PMF in our Plant Master File Guide.
- Essential Principles Compliance Checklist
- Risk Management File aligned with ISO 14971 standards (Risk Management overview)
- Test Reports from Approved Labs
- Product Labels and Instructions for Use (IFU)
- Quality Management System (QMS) Documentation, preferably ISO 13485:2016 certification
Import License Process (MD15) for Sterile Isolation Gowns
For importers, the MD15 license is mandatory and is issued by the Central Licensing Authority. The process includes:
- Document Preparation: Compile all required documents including the manufacturing license from the country of origin, Free Sale Certificate, ISO 13485 certification, CE Certificate, Device Master and Plant Master Files.
- Submit Application (Form MD14): File your application on the CDSCO MD Online Portal.
- Query Resolution: Respond promptly to any clarifications.
- Grant of License (Form MD15): Upon satisfactory review, CDSCO grants the import license.
Import License Documents Required
- Valid Manufacturing License from the country of origin
- Free Sale Certificate
- ISO 13485:2016 Certification
- CE Certificate (if applicable)
- Device Master File
- Plant Master File
- Wholesale License
- Company Constitution Documents
Timeline and Processing Duration
| License Type | Estimated Timeframe | Key Milestones |
|---|---|---|
| Test License (MD13) | 1.5 to 2 months | Sample manufacturing and testing |
| MD5 License | 3 to 4 months (including test license) | Application, notified body audit, query resolution |
| MD15 License | 5 to 6 months | Document review, queries, license grant |
Government Fees and Costs
| License Type | Application Fee | Per Product Fee |
|---|---|---|
| MD5 | Rs. 5,000 | Rs. 500 per product |
| MD15 (Class B) | $2,000 (approx Rs. 1.6 lakh) | $1,000 (approx Rs. 80,000) per product |
Note: Fees are subject to change; always verify current amounts on the CDSCO portal.
Common Challenges and Solutions
- Delayed Test Reports: Choose CDSCO-recognized labs with quick turnaround times. Early sample submission helps.
- Incomplete Documentation: Use comprehensive checklists and seek expert review to ensure nothing is missed.
- Notified Body Audit Failures: Conduct internal audits and pre-assessments to prepare your facility.
- Query Resolution Delays: Respond promptly with clear, well-documented answers.
Expert Consultation and Support
Navigating CDSCO licensing can be complex, especially for Class B devices like sterile isolation gowns. Our 25+ years of regulatory consultancy have empowered 500+ companies to achieve compliant, timely approvals. We provide:
- Customized gap analysis
- Document preparation and review
- Coordination with notified bodies and labs
- End-to-end application management
Partnering with experienced consultants can reduce your approval timeline by up to 30%, saving costs and accelerating market entry.
Getting Started with Your CDSCO License Application
- Assess Your Product Classification: Confirm your gown as Class B under CDSCO regulations.
- Prepare Testing Samples: Apply for the test license (MD13) immediately to avoid bottlenecks.
- Gather Required Documents: Use our detailed document checklist to organize your submission.
- Select Notified Body and Testing Labs: Engage early with notified bodies and approved labs found on the CDSCO notified bodies list and testing labs list.
- Submit Test License Application: File via the CDSCO MD Online Portal.
- Plan for Audit: Schedule pre-audit readiness reviews.
- Apply for MD5 License: After successful testing and audit, apply for the manufacturing license.
Starting early and following these steps with expert oversight ensures a smooth CDSCO licensing journey for your sterile isolation gowns. Contact us today to leverage our expertise and accelerate your compliance process.
