CDSCO License for Garment, Protective for Incontinence
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
Intended to protect an incontinent patient's garment from the patient's excreta.
Comprehensive Guide to CDSCO Licensing for Garment, Protective for Incontinence (Class A PPE)
As a trusted regulatory consultancy with over 25 years of experience and having assisted more than 500 companies in successfully obtaining CDSCO licenses, we understand the nuances of navigating India's medical device regulations. This guide focuses on the Garment, Protective for Incontinence, a Class A medical device under Personal Protective Equipment (PPE), and provides detailed, actionable steps to help manufacturers and importers secure their CDSCO manufacturing or import licenses efficiently.
Understanding the Device and Regulatory Importance
The Garment, Protective for Incontinence is specifically designed to safeguard an incontinent patient's clothing from contamination by excreta. Classified as a Class A device, it falls under the lowest risk category as per the Medical Device Rules (MDR) 2017. Despite its low risk, regulatory compliance is mandatory to ensure patient safety and market access in India.
The device is officially notified under File No. 29/Misc./03/2020-DC (186), dated 13.09.2021, reinforcing its categorization under Personal Protective Equipment.
CDSCO Regulatory Framework for Garment, Protective for Incontinence
Regulated by the Central Drugs Standard Control Organization (CDSCO), this device requires a State Licensing Authority approval for manufacturing (MD5 license) and Central Licensing Authority approval for imports (MD15 license). The regulation aims to maintain quality, safety, and efficacy standards, ensuring that manufacturers comply with statutory requirements.
Risk Classification and License Requirements
- Risk Class: A (Low risk)
- Applicable License: MD5 Manufacturing License (Application Form MD3)
- Licensing Authority: State Licensing Authority
- Timeline: Approximately 3-4 months
For imports, the MD15 license is applicable, which is granted by the Central Licensing Authority and takes about 5-6 months.
To confirm device classification and other regulatory details, manufacturers can refer to the Medical Device Classification guide.
Manufacturing License Process (MD5 License)
The MD5 license is mandatory for manufacturing Class A devices such as the Garment, Protective for Incontinence. The process involves several critical stages:
Test License Application (Form MD13): Initiate by applying for a test license, which takes approximately 1.5 to 2 months. This allows you to manufacture the device in limited quantities for testing purposes.
Product Testing: Conduct mandatory product testing at government-approved laboratories. Tests should confirm compliance with relevant standards for PPE and protective garments. Refer to the list of Testing Laboratories authorized by CDSCO.
Documentation Preparation: Compile comprehensive documentation including Device Master File (DMF), Plant Master File (PMF), Quality Management System (QMS) documents, and Risk Management files.
Application Submission (Form MD3): Apply for the manufacturing license via the CDSCO MD Online Portal.
Audit by Notified Body: A notified body will conduct a manufacturing site audit. You can check the list of notified bodies approved for MD5 audits.
Resolution of Queries: Address any queries raised by the CDSCO or the notified body promptly.
Grant of License (Form MD5): Upon satisfactory audit and document review, the license is granted.
Manufacturing License Documents Required
For the Garment, Protective for Incontinence, the following documents must be meticulously prepared:
- Company Constitution/Registration Certificate
- Proof of ownership or lease agreement of the manufacturing premises
- Qualification and experience details of technical staff
- Fire NOC and Pollution Control Board NOC
- Device Master File (DMF): Detailed design, specifications, and manufacturing process documentation. Learn more from our Device Master File guide.
- Plant Master File (PMF): Details about manufacturing facilities and equipment. Refer to our Plant Master File guide.
- Essential Principles Checklist confirming compliance with MDR 2017
- Risk Management File demonstrating risk assessment and mitigation strategies
- Test Reports from approved laboratories
- Product Labels and Instructions for Use (IFU)
- Quality Management System (QMS) documentation, preferably ISO 13485:2016 certification
Import License Process (MD15 License)
For importers intending to bring in Garment, Protective for Incontinence into India, the MD15 import license is mandatory. The key steps include:
Document Preparation: Assemble all necessary documents, including a valid manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate (if applicable), and detailed device information.
Application Submission: Submit the application using Form MD14 on the CDSCO MD Online Portal.
Review and Queries: Respond to any clarifications or additional information requests by CDSCO.
License Grant: On satisfactory review, CDSCO issues the MD15 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 (if applicable)
- Company Constitution
Timeline and Processing Duration
| Stage | Duration |
|---|---|
| Test License (MD13) | 1.5 - 2 months |
| Product Testing | 1 - 1.5 months |
| Document Preparation | 2 - 3 weeks |
| License Application Processing | 1 - 1.5 months |
| Audit and Query Resolution | 3 - 4 weeks |
| Total Time for MD5 License | Approx. 3 - 4 months |
For import licenses (MD15), the total timeline typically ranges from 5 to 6 months.
Government Fees and Costs
MD5 Manufacturing License:
- Application Fee: Rs. 5,000 per application
- Product Fee: Rs. 500 per product
MD15 Import License: (Fees vary by risk class; Class A as below)
- Site Fee: Approximately $1,000 per site
- Product Fee: Approximately $50 per product
Fees are payable online through the CDSCO portal.
Common Challenges and Solutions
Incomplete Documentation: One of the most frequent pitfalls is submitting incomplete or inconsistent documents. We recommend using detailed checklists and templates for DMF and PMF to avoid errors.
Delayed Testing Results: Testing can be delayed if laboratories are overbooked. Plan testing early and select labs from the official Testing Laboratories list.
Audit Non-compliance: Non-adherence to QMS or facility standards leads to audit failures. Prior internal audits and mock inspections significantly improve success rates.
Query Resolution Delays: Prompt and clear responses to CDSCO queries accelerate license approval.
Expert Consultation and Support
With our extensive experience, we assist manufacturers and importers in:
- Preparing regulatory strategies tailored to Class A PPE devices
- Compiling and reviewing comprehensive documentation
- Liaising with notified bodies and CDSCO authorities
- Facilitating product testing and audit readiness
- Providing training on regulatory compliance
Our proactive approach reduces approval times and mitigates risks of rejection.
Getting Started with Your CDSCO License Application
To initiate your CDSCO licensing for the Garment, Protective for Incontinence:
Register on the CDSCO MD Online Portal: Begin by creating an account on the official CDSCO MD Online Portal.
Classify Your Device: Confirm the risk class and applicable license type using reliable classification tools and the Medical Device Classification resource.
Prepare Documentation: Start compiling your Device Master File and Plant Master File in compliance with regulatory standards.
Apply for Test License (MD13): Submit your test license application to enable initial production for testing.
Schedule Product Testing: Engage with government-approved laboratories early to avoid bottlenecks.
Plan for Audit: Select a notified body for your manufacturing site audit and ensure compliance.
Submit Manufacturing License Application (MD3): After successful testing and documentation readiness, apply for the MD5 license.
Following these steps systematically will place you on a clear path towards obtaining your CDSCO manufacturing license for this Class A device.
For personalized support, regulatory updates, and expert guidance, reach out to our consultancy team—trusted by over 500 companies to navigate the Indian medical device regulatory landscape successfully.
