CDSCO License for Elasticated Cohesive Bandage

Comprehensive Guide to CDSCO Licensing for Elasticated Cohesive Bandage (Class A Medical Device)

As a trusted regulatory consultancy with over 25 years of experience and having successfully assisted more than 500 companies in securing CDSCO licenses, we understand the nuances and critical steps involved in licensing medical devices in India. This guide provides detailed, actionable insights specifically for the Elasticated Cohesive Bandage, classified as a Class A medical device under the General Hospital or Orthopaedic Instruments category.

Introduction: Elasticated Cohesive Bandage and Regulatory Importance

Elasticated Cohesive Bandages are commonly used to secure dressings and for strapping on intact skin, offering flexibility and secure adhesion without adhesives. Despite being low-risk devices (Class A), manufacturers and importers must comply with CDSCO regulations to ensure product safety and market access in India. Proper licensing not only fulfills legal requirements but also builds trust with healthcare providers and distributors.

CDSCO Regulatory Framework for Elasticated Cohesive Bandage

The Central Drugs Standard Control Organization (CDSCO) oversees the regulatory framework for medical devices in India. Since the notification dated 16.03.2022 (29/Misc./03/2020-DC (193)- Part-3), Elasticated Cohesive Bandages are regulated as Class A devices, requiring a manufacturing license known as MD5, issued by State Licensing Authorities.

Risk Classification and License Requirements

• Risk Class: A (Low risk)
• License Type: MD5 Manufacturing License
• Authority: State Licensing Authority
• Application Form: MD3

Class A devices like Elasticated Cohesive Bandages benefit from a streamlined regulatory pathway but must still meet rigorous documentation and testing standards before license approval.

Manufacturing License Process (MD5) for Elasticated Cohesive Bandage

1. Test License Application (Form MD13): Initiate by applying for a test license, which typically takes 1.5 to 2 months. This license permits product testing in government-approved laboratories.
2. Product Testing: Conduct mandatory testing through CDSCO-approved labs to verify compliance with relevant standards. Refer to the list of testing laboratories for authorized facilities.
3. Document Preparation: Assemble comprehensive documentation, including Device Master File (DMF), Plant Master File (PMF), Essential Principles Checklist, Risk Management File, and Quality Management System (QMS) documents.
4. Licensing Application (Form MD3): Submit the MD5 manufacturing license application via the CDSCO MD Online Portal.
5. Notified Body Audit: Undergo an on-site audit by a notified body accredited for Class A devices. Check the list of notified bodies to select an authorized auditor.
6. Query Resolution: Address any queries or observations raised by the licensing authority or notified body promptly.
7. Grant of License: Upon successful audit and document verification, the State Licensing Authority grants the MD5 license on Form MD5.

Manufacturing License Documents Required

• Company Constitution (Certificate of Incorporation, Partnership Deed, etc.)
• Proof of Ownership or Lease of Manufacturing Premises
• Details and Qualifications of Technical Staff
• Fire NOC and Pollution Control NOC
• Device Master File (Refer to our detailed Device Master File guide)
• Plant Master File (See our Plant Master File guide)
• Essential Principles Checklist confirming compliance with Indian medical device standards
• Risk Management File demonstrating hazard analysis and mitigation strategies
• Test Reports from CDSCO-approved laboratories
• Product Labels and Instructions for Use (IFU)
• Quality Management System Documents (ISO 13485 certification strongly recommended)

Import License Process (MD15) for Elasticated Cohesive Bandage

For importers, the MD15 license is mandatory, issued by the Central Licensing Authority. The process involves:

1. Document Preparation: Compile necessary documents including the manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certificate, CE certificate (if applicable), Device and Plant Master Files, wholesale license, and company constitution.
2. Application Submission: Apply using Form MD14 on the CDSCO MD Online Portal.
3. Query Resolution: Respond promptly to any clarifications sought by CDSCO.
4. License Grant: MD15 license issued post satisfactory review.

Note: Import licenses for Class A devices typically take 5-6 months and involve fees as per CDSCO guidelines.

Import License Documents Required

• Valid Manufacturing License from Country of Origin
• Free Sale Certificate
• ISO 13485:2016 Certification
• CE Certificate (if applicable)
• Device Master File and Plant Master File
• Wholesale License
• Company Constitution

Timeline and Processing Duration

Total Estimated Time: Approximately 3 to 4 months for MD5 manufacturing license.

Government Fees and Costs

• Test License (MD13): Nominal fees; varies by state
• MD5 License Application: ₹5,000 per application + ₹500 per product
• Notified Body Audit Fees: Varies by auditor, typically ₹50,000 to ₹1,00,000
• Product Testing Fees: Dependent on the number of tests and laboratories used

Practical Tip: Budget for contingency costs related to audit observations or additional testing.

Common Challenges and Solutions

Challenge 1: Delays in Product Testing

• Solution: Engage with CDSCO-approved labs early and confirm testing timelines upfront.

Challenge 2: Incomplete Documentation Leading to Queries

• Solution: Use checklist-based document preparation, referencing our Device Master File guide and Plant Master File guide.

Challenge 3: Audit Non-compliance

• Solution: Conduct internal pre-audit assessments to ensure QMS and manufacturing practices meet notified body expectations.

Challenge 4: Unfamiliarity with CDSCO Portal

• Solution: We recommend hands-on training or expert assistance for smooth portal navigation and timely application submission.

Expert Consultation and Support

Navigating the CDSCO licensing process can be complex, especially for first-time applicants. Our consultancy has supported over 500 manufacturers and importers through every step—from documentation to final license grant. We offer:

• Customized gap assessments
• Document drafting and review
• Liaison with notified bodies and CDSCO officials
• Audit readiness training
• Post-license compliance support

Getting Started with Your CDSCO License Application

1. Identify Risk Class: Confirm your device is Class A as per CDSCO classification (Medical Device Classification).
2. Apply for Test License: Submit Form MD13 via the CDSCO MD Online Portal.
3. Engage Approved Testing Labs: Schedule product testing early.
4. Prepare Comprehensive Documentation: Utilize our Device and Plant Master File guides.
5. Select Notified Body: Choose an authorized notified body from the official list of notified bodies.
6. Submit MD5 Application (Form MD3): After successful testing and documentation readiness.
7. Prepare for Audit: Conduct internal audits and corrective actions before notified body inspection.
8. Respond to Queries Promptly: Maintain clear communication with CDSCO and notified bodies.

Embarking on this journey with expert guidance ensures faster approvals and market entry. Contact us today to leverage our industry-leading expertise and make your Elasticated Cohesive Bandage CDSCO compliant with confidence.