CDSCO License for Tearable Adhesive Tape
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.
Introduction to Tearable Adhesive Tape and Its Regulatory Importance
Tearable Adhesive Tape is a Class A medical device primarily used to secure dressings and for strapping on intact skin. Classified under General Hospital or Orthopaedic Instruments, this device plays a critical role in wound care management. Given its direct contact with intact skin, regulatory compliance is essential to ensure safety, efficacy, and market authorization in India. With the Central Drugs Standard Control Organization (CDSCO) Notification 29/Misc./03/2020-DC (193)- Part-3 dated 16.03.2022, Tearable Adhesive Tape is regulated under India’s medical device framework, requiring manufacturers and importers to obtain the appropriate license to legally market this product.
With over 25 years of experience and having supported 500+ companies in CDSCO licensing, we provide you with a detailed roadmap for seamless regulatory approval tailored specifically for Tearable Adhesive Tape.
CDSCO Regulatory Framework for Tearable Adhesive Tape
As a Class A medical device, Tearable Adhesive Tape falls under the least stringent risk category but still requires a Manufacturing License (MD5) issued by the State Licensing Authority. The CDSCO mandates compliance with essential principles of safety, quality management systems (QMS), and product-specific documentation.
The regulatory process involves:
- Obtaining a Test License (MD13) for initial product testing
- Product testing at CDSCO-approved laboratories
- Preparing and submitting a comprehensive license application (Form MD3) for MD5 Manufacturing License
- Undergoing an audit by a notified body
- Responding to departmental queries before the grant of license
You can submit applications through the CDSCO MD Online Portal.
Risk Classification and License Requirements for Tearable Adhesive Tape
According to the CDSCO classification, Tearable Adhesive Tape is Class A, denoting minimal risk.
License Type: MD5 Manufacturing License (Form MD3)
Authority: State Licensing Authority
Process Duration: Approximately 3-4 months (including test license and audit)
Testing: Mandatory product testing in government-approved laboratories
Check the medical device classification for further details.
Manufacturing License Process (MD5) for Tearable Adhesive Tape
Apply for Test License (MD13): This preliminary step permits you to conduct product testing. The test license is valid for 1.5 to 2 months, enabling you to send samples to government-approved labs.
Product Testing: Tearable Adhesive Tape samples must be tested at CDSCO-recognized testing laboratories to validate quality parameters such as adhesion strength, biocompatibility, and sterility (if applicable). Refer to the list of Testing Laboratories.
Prepare License Application: Upon successful testing, assemble your license dossier including technical, quality, and administrative documents.
Submit Application (Form MD3): File the manufacturing license application through the CDSCO MD Online Portal.
Notified Body Audit: A notified body conducts an on-site audit of your manufacturing facilities and QMS. You can review the Notified Bodies List to select the appropriate body.
Address Queries: Respond promptly to any observations or queries from CDSCO or the notified body.
License Grant: After clearing all requirements, the State Licensing Authority issues the MD5 license.
Manufacturing License Documents Required for Tearable Adhesive Tape
- Company Constitution (Certificate of Incorporation, Partnership Deed, etc.)
- Proof of ownership or lease agreement of the manufacturing premises
- Details and qualifications of technical staff
- Fire NOC and Pollution Control NOC
- Device Master File (DMF) outlining product specifications and manufacturing process — see our detailed Device Master File guide
- Plant Master File (PMF) describing facility layout and equipment — refer to our Plant Master File guide
- Essential Principles Compliance Checklist
- Risk Management File demonstrating hazard analysis and mitigation strategies — learn more about medical device risk management
- Product Test Reports from government-approved labs
- Product labels and Instructions for Use (IFU)
- Quality Management System (QMS) documentation (ISO 13485:2016 certification recommended)
Ensure that all documents are current, accurate, and properly formatted to avoid delays.
Import License Process (MD15) for Tearable Adhesive Tape
For importers, MD15 Import License is mandatory and issued by the Central Licensing Authority.
Key Points:
- No test license required prior to application
- Submit detailed application with supporting documents including manufacturing license, Free Sale Certificate, ISO 13485:2016 certification, CE certificate (if applicable), and wholesale license
- Processing takes approximately 5-6 months
We recommend reviewing the comprehensive Import License guide for detailed steps.
Import License Documents Required
- Manufacturing License (MD5 or MD9) from country of origin
- Free Sale Certificate
- ISO 13485:2016 Quality Management System certificate
- CE Certificate or equivalent, if applicable
- Device Master File and Plant Master File
- Wholesale License
- Company Constitution and address proof
Timeline and Processing Duration
| Process Step | Duration |
|---|---|
| Test License (MD13) | 1.5 – 2 months |
| Product Testing | 2 – 3 weeks (varies) |
| Document Preparation | 2 – 4 weeks |
| License Application | Submission online |
| Notified Body Audit | 4 – 6 weeks |
| Query Resolution | 2 – 4 weeks |
| License Grant (MD5) | Total: Approximately 3-4 months |
Note: Delays often occur during audit scheduling and query resolution phases.
Government Fees and Costs
- Test License (MD13): Nominal fees as per state regulations
- MD5 Manufacturing License: Rs 5,000 per application plus Rs 500 per product
For Tearable Adhesive Tape, as a single product, expect total government fees in the range of Rs 5,500.
Additional costs include notified body audit fees (varies by body), product testing charges at approved labs, and consultancy/document preparation fees.
Common Challenges and Solutions
Challenge: Delays in product testing due to lab backlogs.
Solution: Submit samples promptly after test license issuance and choose labs with shorter turnaround times.
Challenge: Non-compliance in documentation leading to repeated queries.
Solution: Engage experienced regulatory consultants to pre-review and align documents with CDSCO requirements.
Challenge: Scheduling audits with notified bodies.
Solution: Initiate audit requests early and maintain regular communication with notified bodies.
Challenge: Understanding evolving regulatory norms.
Solution: Stay updated with CDSCO notifications and seek expert advice.
Expert Consultation and Support
Navigating CDSCO licensing for Tearable Adhesive Tape can be complex, especially for first-time manufacturers or importers. Our team, with 25+ years’ experience and 500+ successful CDSCO approvals, offers end-to-end support:
- Gap analysis of your current compliance status
- Preparation and review of Device and Plant Master Files
- Assistance with test license application and liaison with testing labs
- Coordination with notified bodies for audits
- Timely responses to regulatory queries
- Post-license compliance and renewal support
Partnering with experts reduces errors, accelerates approvals, and ensures market readiness.
Getting Started with Your CDSCO License Application for Tearable Adhesive Tape
Assess your product classification and applicable license type. For Tearable Adhesive Tape, confirm Class A classification.
Register your organization on the CDSCO MD Online Portal.
Apply for the Test License (MD13) to initiate product testing.
Collect samples and send to CDSCO-approved laboratories.
Simultaneously prepare your Device Master File, Plant Master File, and QMS documentation.
After receiving test reports, submit your MD5 Manufacturing License application (Form MD3).
Schedule and complete the notified body audit promptly.
Address any queries and await license grant.
By following these steps and leveraging professional guidance, you can efficiently secure your CDSCO license and successfully launch Tearable Adhesive Tape in the Indian healthcare market.
For personalized assistance or to discuss your project, contact us today and benefit from our proven expertise in medical device regulatory affairs.
