CDSCO License for Adhesive Tape USP
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
It is intended to secure dressings and for strapping on intact skin .
Comprehensive Guide to CDSCO Licensing for Adhesive Tape USP (Class A Medical Device)
As seasoned regulatory consultants with over 25 years of experience, we have successfully assisted 500+ manufacturers and importers in securing CDSCO licenses for various medical devices, including Class A products like Adhesive Tape USP. This guide provides detailed, practical insights into the regulatory framework, application process, documentation, timelines, and fees specific to Adhesive Tape USP, classified under General Hospital or Orthopaedic Instruments.
Introduction to Adhesive Tape USP and Its Regulatory Importance
Adhesive Tape USP is primarily intended to secure wound dressings and for strapping on intact skin, making it an essential consumable in healthcare settings. Despite its seemingly simple application, regulatory compliance is critical to ensure safety, quality, and market access in India. Complying with the CDSCO licensing framework not only fulfills legal obligations but also enhances product credibility among healthcare providers.
CDSCO Regulatory Framework for Adhesive Tape USP
Adhesive Tape USP falls under the Class A category as per the Indian Medical Device Rules (MDR) and the notification 29/Misc./03/2020-DC (193)- Part-3 dated 16.03.2022. Class A devices are considered low risk; hence, the licensing process is managed by the State Licensing Authority and involves obtaining an MD5 manufacturing license.
Risk Classification and License Requirements
- Risk Class: A (Low risk)
- Regulatory Authority: State Licensing Authority
- License Type: MD5 – Manufacturing License (Application Form MD3)
- Applicable Notification: 29/Misc./03/2020-DC (193)- Part-3
For detailed classification reference, manufacturers can verify Medical Device Classification guidelines.
Manufacturing License Process for Adhesive Tape USP (MD5 License)
The MD5 license process involves multiple stages:
Test License (Form MD13): Initially, you must apply for a test license, which allows limited manufacturing for product testing. This step typically takes 1.5–2 months.
Laboratory Testing: Samples of Adhesive Tape USP must be tested in government-approved labs to comply with quality standards. Refer to the list of testing laboratories sanctioned by CDSCO.
Document Preparation: Compile comprehensive documentation including Device Master File, Plant Master File, Essential Principles Checklist, Risk Management File, and Quality Management System (QMS) documents.
Application Submission: Submit the manufacturing license application (Form MD3) on the CDSCO MD Online Portal.
Audit by Notified Body: A notified body will conduct an audit of your manufacturing facility and quality systems. You can check the list of notified bodies authorized to perform these audits.
Query Resolution: Address any observations or queries raised by the regulatory authority or notified body promptly.
License Grant (Form MD5): Upon satisfactory review and audit, CDSCO will grant the MD5 manufacturing license.
Manufacturing License Documents Required for Adhesive Tape USP
The document dossier for MD5 license includes:
- Company Constitution Documents (e.g., MOA, AOA)
- Proof of Ownership or Lease Agreement of Manufacturing Premises
- Qualification and Experience Certificates of Technical Staff
- Fire No Objection Certificate (NOC)
- Pollution Control Board NOC
- Device Master File (DMF): Detailing product specifications and manufacturing process (Guide to DMF)
- Plant Master File (PMF): Describing manufacturing facility and quality control systems (Guide to PMF)
- Essential Principles Checklist ensuring compliance with safety and performance standards
- Risk Management File tailored for Adhesive Tape USP (Risk Management Guide)
- Test Reports from CDSCO-approved labs
- Product Labels and Instructions for Use (IFU)
- Quality Management System Documents (e.g., ISO 13485 certificates)
Import License Process for Adhesive Tape USP (MD15 License)
While this guide primarily focuses on manufacturing licenses, importers of Adhesive Tape USP require an MD15 license granted by the Central Licensing Authority. The process involves document preparation, application submission via Form MD14, and license issuance within approximately 5–6 months. For detailed insight, refer to our Import License guide.
Timeline and Processing Duration
| Stage | Duration |
|---|---|
| Test License (MD13) | 1.5 – 2 months |
| Product Testing | 2 – 3 weeks |
| Document Preparation | 3 – 4 weeks |
| Application Review & Audit | 1.5 – 2 months |
| Query Resolution | 2 – 3 weeks |
| Total Time | 3 – 4 months |
Timelines may vary based on audit schedules and query complexity. Early preparation drastically reduces delays.
Government Fees and Costs
- Application Fee: Rs. 5,000 per application
- Product Fee: Rs. 500 per product
Additional costs may include:
- Testing charges at government-approved labs
- Audit fees charged by notified bodies
- Consultancy fees if availed
Common Challenges and Practical Solutions
1. Delays in Test License Approval: Submit a thoroughly documented application with complete technical details to avoid back-and-forth queries.
2. Difficulty in Scheduling Audits: Plan audits well in advance and maintain continuous communication with notified bodies.
3. Incomplete Documentation: Utilize checklists and templates for Device Master File and Plant Master File to ensure all aspects are covered.
4. Non-compliance in Risk Management: Implement a robust risk management system early in product development to align with CDSCO expectations.
Expert Consultation and Support
With our extensive experience, we provide end-to-end assistance including:
- Gap analysis of existing documentation
- Preparation of Device and Plant Master Files
- Coordination with notified bodies and testing labs
- Application submission and follow-up
- Training on regulatory compliance and quality systems
Our proactive approach ensures a smooth licensing journey, minimizing unforeseen hurdles.
Getting Started with Your CDSCO License Application for Adhesive Tape USP
Evaluate Your Product Classification: Confirm your device falls under Class A using the official CDSCO notifications and classification tools.
Initiate Test License Application: Gather all preliminary documents and apply for the test license (Form MD13) via the CDSCO MD Online Portal.
Engage with Approved Testing Laboratories: Prepare product samples and coordinate testing schedules early to avoid timeline overruns.
Prepare Comprehensive Documentation: Develop your Device Master File and Plant Master File, referencing our detailed guides.
Schedule and Prepare for Audit: Select a notified body from the official list and address all audit readiness aspects.
Submit Manufacturing License Application: Complete and upload Form MD3 through the CDSCO portal, ensuring accuracy to prevent processing delays.
Respond Promptly to Queries: Assign dedicated personnel to handle regulatory communication efficiently.
Adhering to these actionable steps significantly enhances your chances of timely CDSCO MD5 license approval for Adhesive Tape USP. For personalized assistance and to navigate the regulatory landscape seamlessly, connect with our expert team today.
