CDSCO License for Tearable adhesive plaster

Understanding Tearable Adhesive Plaster and Its Regulatory Importance

Tearable adhesive plasters are essential medical devices widely used in healthcare settings to secure dressings and provide skin strapping. Classified under Class A, these plasters fall into the low-risk category as per the CDSCO framework and are grouped within the General Hospital or Orthopaedic Instruments category. Their intended use on intact skin requires strict adherence to quality and safety standards to protect patients and ensure product efficacy.

Given the crucial role this device plays in everyday medical procedures, obtaining the correct CDSCO license is mandatory for manufacturers and importers aiming to market tearable adhesive plasters in India. Regulatory compliance guarantees that the device meets Indian and international safety norms, thus fostering trust among healthcare providers and end-users.

CDSCO Regulatory Framework for Tearable Adhesive Plasters (Class A)

The Central Drugs Standard Control Organization (CDSCO) governs the regulation of medical devices in India, categorizing them based on risk. As a Class A device, tearable adhesive plasters require licensing through the State Licensing Authority under the MD5 license scheme. This classification ensures a streamlined process with fewer regulatory hurdles compared to higher-risk devices.

The regulatory framework includes mandatory testing, documentation, audit, and compliance with essential principles outlined by CDSCO. It is crucial to follow the prescribed steps meticulously to avoid delays or rejection.

Risk Classification and License Requirements for Tearable Adhesive Plasters

• Risk Class: A (Low Risk)
• License Type: MD5 Manufacturing License (Form MD3)
• Licensing Authority: State Licensing Authority
• Regulatory Notification: 29/Misc./03/2020-DC (193)- Part-3, dated 16.03.2022

For Class A devices, the MD5 license is mandatory for manufacturing within India. Importers will require an Import License (MD15) granted by the Central Licensing Authority.

Manufacturing License Process (MD5) for Tearable Adhesive Plasters

The manufacturing license process for Class A devices spans approximately 3 to 4 months and involves several key stages:

1. Test License (Form MD13): Obtain a test license valid for 3 months to conduct product testing in government-approved laboratories. This step typically takes 1.5 to 2 months.

2. Product Testing: Conduct mandatory tests as per standards prescribed for adhesive plasters in notified laboratories. You can find a list of such labs on the CDSCO Testing Laboratories page.

3. Documentation Preparation: Compile required documents, including technical and quality files.

4. License Application (Form MD3): Submit the manufacturing license application via the CDSCO MD Online Portal.

5. Audit by Notified Body: Upon application, an audit by a notified body listed on the Notified Bodies List is conducted to verify compliance.

6. Query Resolution: Address any queries raised by the licensing authority or notified body promptly.

7. License Grant (Form MD5): Once all criteria are satisfactorily met, the MD5 license is granted.

Manufacturing License Documents Required for Tearable Adhesive Plasters

Completeness and accuracy of documentation are critical for smooth processing. The following documents are required:

• Company Constitution (e.g., Memorandum & Articles of Association)
• Proof of Ownership or Lease of Manufacturing Premises
• Details and Qualifications of Technical Staff
• Fire Safety NOC
• Pollution Control Board NOC
• Device Master File detailing product specifications and design (refer our Device Master File guide)
• Plant Master File describing manufacturing facilities (see our Plant Master File guide)
• Essential Principles Checklist confirming compliance with CDSCO regulations
• Risk Management File highlighting risk analysis and mitigation strategies (learn more about Risk Management)
• Test Reports from government-approved laboratories
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documentation, preferably ISO 13485 certified

Import License Process (MD15) for Tearable Adhesive Plasters

If you intend to import tearable adhesive plasters into India, an Import License under Form MD14 is required, which leads to the issuance of MD15 license. The process takes approximately 5 to 6 months and is managed by the Central Licensing Authority.

1. Document Preparation: Collect all necessary import documentation, including the manufacturing license, Free Sale Certificate, ISO 13485:2016, CE certificate, and others.

2. License Application: Submit the application via the CDSCO MD Online Portal.

3. Query Resolution: Respond promptly to any departmental queries.

4. License Grant: Upon successful review, the MD15 Import License is granted.

Import License Documents Required for Tearable Adhesive Plasters

• Valid Manufacturing License from the country of origin
• Free Sale Certificate or equivalent
• ISO 13485:2016 Certification
• CE Certificate (if applicable)
• Device Master File
• Plant Master File
• Wholesale License
• Company Constitution

Timeline and Processing Duration

Import License (MD15) can take up to 5-6 months due to central authority processing and detailed document verification.

Government Fees and Costs

• MD5 Manufacturing License:

  • Application Fee: Rs. 5,000
  • Per Product Fee: Rs. 500

• Test License (MD13): Usually included in the application process or separately charged depending on the state

• Import License (MD15) for Class A Devices: Approx. $1000 per site and$50 per product

Budgeting for these fees upfront will help avoid surprises during the application process.

Common Challenges and Solutions

• Incomplete Documentation: Missing or inconsistent documents are a leading cause of delays. We recommend early preparation and thorough cross-verification.

• Testing Delays: Scheduling tests at government-approved laboratories can take time. Book appointments early and ensure samples meet test criteria.

• Audit Non-Compliance: Ensure the manufacturing facility and QMS are audit-ready by conducting internal audits prior to the notified body visit.

• Query Management: Respond to CDSCO queries promptly and with precise information to avoid prolonged processing times.

• Understanding Regulatory Updates: Stay updated with the latest CDSCO notifications, including the 16.03.2022 notification specifically affecting adhesive plasters.

Expert Consultation and Support

With over 25 years of regulatory experience and having assisted 500+ companies, we provide end-to-end support—from documentation to audit readiness and license submission. Our team helps navigate complex CDSCO procedures efficiently, reducing time-to-market and mitigating risks.

We offer tailored solutions for manufacturers and importers of tearable adhesive plasters, ensuring compliance with national and international standards.

Getting Started with Your CDSCO License Application for Tearable Adhesive Plasters

1. Assess Your Device Classification: Confirm your product’s Class A status using official CDSCO resources or our Medical Device Classification guide.

2. Prepare Documentation: Utilize our Device Master File and Plant Master File guides to compile necessary files.

3. Apply for Test License: Submit Form MD13 via the CDSCO MD Online Portal and schedule product testing.

4. Complete Product Testing: Coordinate with approved laboratories listed on the CDSCO portal.

5. Submit Manufacturing License Application: File Form MD3 on the CDSCO portal after preparing for the notified body audit.

6. Prepare for Audit: Engage with a notified body from the official Notified Bodies List to schedule your audit.

7. Respond to Queries and Obtain License: Address all regulatory queries promptly to receive your MD5 license.

Embarking on the CDSCO licensing journey for tearable adhesive plasters requires strategic planning and expert knowledge. Our proven track record and comprehensive support can help you successfully navigate this process and bring your product to the Indian market with confidence.