CDSCO License for Isolation Gown (Non-Sterile)
Medical Device Information
Important Notice for Class A Devices
Class A Non-sterile Non Measuring devices are exempt from MD5 and MD15 licenses. Only CDSCO registration is required as per GSR 777(E).
Intended Use
A non-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 Isolation Gown (Non-Sterile) – Class A Medical Device
Isolation gowns (non-sterile) are critical personal protective equipment (PPE) designed to shield healthcare providers and visitors from contagious agents. Given their essential role in infection control, these gowns fall under Class A risk classification by CDSCO, India’s regulatory authority for medical devices. Navigating the regulatory landscape efficiently is vital for manufacturers and importers aiming to enter the Indian market.
With over 25 years of experience and having assisted 500+ companies in securing CDSCO licenses, we provide a detailed walkthrough of the licensing process, timelines, costs, and practical advice specifically tailored for non-sterile isolation gowns.
CDSCO Regulatory Framework for Isolation Gown (Non-Sterile)
The Central Drugs Standard Control Organization (CDSCO) regulates medical devices under the Medical Device Rules (MDR) 2017. Isolation gowns, classified as Class A devices, are considered low-risk. The regulatory framework mandates obtaining a manufacturing license (MD5) or import license (MD15) depending on your business model.
The notification for Isolation Gown (File No. 29/Misc./03/2020-DC (186), dated 13.9.2021) confirms its classification and regulatory requirements. Compliance with safety standards and quality management systems is critical.
Risk Classification and License Requirements for Isolation Gown
Isolation gowns fall under Class A – low risk, non-invasive devices. This classification dictates:
- Manufacturing License: MD5 (Form MD3) issued by the State Licensing Authority
- Import License: MD15 issued by the Central Licensing Authority
Class A devices benefit from a streamlined regulatory pathway but still require adherence to documentation, testing, and audit protocols.
Manufacturing License Process for Isolation Gown (MD5)
The MD5 license process involves several sequential steps:
- Test License Application (Form MD13): Apply first for a test license, valid for 6 months, allowing product testing in CDSCO-approved labs.
- Product Testing: Submit samples to notified government laboratories for testing compliance.
- Document Preparation: Compile comprehensive documentation including Device Master File and Plant Master File.
- License Application (Form MD3): Submit the MD5 license application via the CDSCO MD Online Portal.
- Audit by Notified Body: The State Authority appoints a notified body to audit the manufacturing site and quality systems.
- Query Resolution: Address any queries or deficiencies raised by the authority or auditor.
- Grant of License (Form MD5): Upon successful compliance, the manufacturing license is issued.
For more detailed guidance, refer to our dedicated MD5 License Guide.
Manufacturing License Documents Required for Isolation Gown
To ensure a smooth application, prepare the following key documents:
- Company Constitution: Registration certificates, partnership deed, or incorporation documents
- Proof of Premises Ownership: Lease deed or ownership documents
- Technical Staff Records: Qualifications and experience certificates of key personnel
- Fire NOC & Pollution Control NOC: Safety clearances from local authorities
- Device Master File: Detailed product specifications, manufacturing process, and quality controls (See our Device Master File Guide)
- Plant Master File: Details of manufacturing facilities, equipment, and workflow (Plant Master File Guide)
- Essential Principles Checklist: Compliance matrix with MDR requirements
- Risk Management File: Risk analysis and mitigation plan (Risk Management Insights)
- Test Reports: Product test certificates from CDSCO-approved labs (Testing Laboratories List)
- Labels and Instructions for Use (IFU): Draft copies demonstrating compliance with labeling rules
- Quality Management System (QMS) Documents: Procedures and records demonstrating compliance with ISO 13485 or equivalent
Import License Process for Isolation Gown (MD15)
If importing isolation gowns, the MD15 license is mandatory. The process includes:
- Document Preparation: Prepare documents including manufacturing license of the foreign manufacturer, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate, and others.
- License Application (Form MD14): Submit application on the CDSCO MD Online Portal.
- Query Resolution: Respond promptly to any clarifications sought.
- Grant of Import License (Form MD15): Upon verification, the license is granted.
Refer to our focused Import License Guide for step-by-step assistance.
Import License Documents Required
Key documents for MD15 license:
- Valid manufacturing license from the country of origin
- Free Sale Certificate issued by the foreign regulatory authority
- ISO 13485:2016 certification
- CE Certificate (if applicable)
- Device Master File and Plant Master File
- Wholesale license for distribution in India
- Company Constitution
Timeline and Processing Duration
| License Type | Timeline (Approximate) | Key Milestones |
|---|---|---|
| MD5 (Manufacturing) | 3-4 months | 1.5-2 months for Test License + Testing + Audit + Approval |
| MD9 (Higher risk) | 4-5 months | Not applicable for Class A devices |
| MD15 (Import License) | 5-6 months | Document verification and approval |
Our practical experience shows that proactive document preparation and early lab testing reduce delays significantly.
Government Fees and Costs
| License Type | Application Fee | Per Product Fee |
|---|---|---|
| MD5 (Class A) | Rs 5,000 | Rs 500 per product |
| MD15 (Import Class A) | $1000 per site | $50 per product |
Note: Fees are payable online during application submission via the CDSCO portal.
Common Challenges and Solutions
- Delayed Testing Results: Engage with CDSCO-approved labs early; confirm sample requirements and timelines.
- Incomplete Documentation: Use comprehensive checklists and expert review prior to submission.
- Audit Non-Compliance: Conduct internal mock audits; ensure QMS and facility readiness.
- Query Resolution Delays: Assign a dedicated regulatory liaison to respond promptly.
Our track record with 500+ successful applications demonstrates how anticipating these pain points streamlines approvals.
Expert Consultation and Support
Navigating CDSCO regulations requires expertise. Our consultancy offers:
- Tailored gap analysis for your documentation
- Coordination with notified bodies and laboratories
- Preparation for audits and inspections
- End-to-end application management
Partnering with seasoned consultants ensures you avoid costly rejections and expedite market entry.
Getting Started with Your CDSCO License Application
- Assess Your Device Classification: Confirm your isolation gown as Class A via Medical Device Classification.
- Prepare Test Samples: Identify CDSCO-approved labs and initiate product testing early.
- Compile Documents: Use our Device and Plant Master File guides to prepare detailed dossiers.
- Register on CDSCO MD Online Portal: Create your account and submit initial test license application (CDSCO MD Online Portal).
- Schedule Audit: Upon test license approval, coordinate with notified bodies (Notified Bodies List) for audit scheduling.
- Submit Final License Application: After audit and test report submission, apply for the MD5 manufacturing license.
Taking these actionable steps with expert support will position your business for swift regulatory success in India’s growing medical device market.
For personalized assistance tailored to your Isolation Gown manufacturing or import licensing needs, contact us to leverage our 25+ years of CDSCO regulatory expertise and ensure your compliance journey is smooth and efficient.
