CDSCO License for Elastic Adhesive Bandage

Introduction to Elastic Adhesive Bandage and Its Regulatory Importance

Elastic Adhesive Bandages are essential medical devices widely used in clinical settings to secure dressings and provide strapping on intact skin. Classified under General Hospital or Orthopaedic Instruments, these bandages hold a pivotal role in patient care and wound management. Given their direct contact with the skin, ensuring regulatory compliance is crucial for manufacturers and importers aiming to market these devices in India.

With the notification 29/Misc./03/2020-DC (193)- Part-3 dated 16.03.2022, Elastic Adhesive Bandages are classified as Class A medical devices under the Central Drugs Standard Control Organization (CDSCO) framework. This classification signifies a low-risk category but mandates a stringent licensing process to guarantee safety and performance.

Having supported over 500 companies in securing CDSCO licenses, we provide you with comprehensive, actionable insights into obtaining the required approvals for Elastic Adhesive Bandages in India.

CDSCO Regulatory Framework for Elastic Adhesive Bandage

The CDSCO governs the regulation of medical devices in India through the Medical Device Rules (MDR) of 2017, amended periodically. As per these rules, Elastic Adhesive Bandages fall under Class A devices, which are considered low risk. The regulatory oversight for Class A devices is managed by the State Licensing Authority.

The key regulatory steps include:

• Obtaining a Test License (Form MD13) to commence product testing.
• Securing a Manufacturing License (Form MD5) through the State Licensing Authority.
• Ensuring compliance with essential principles, labeling, and quality management requirements.

All applications and document submissions are processed through the CDSCO MD Online Portal, streamlining the licensing process.

Risk Classification and License Requirements for Elastic Adhesive Bandage

Elastic Adhesive Bandages are categorized as Class A devices under the MDR 2017, notified under 29/Misc./03/2020-DC (193)- Part-3 dated 16.03.2022. This classification requires manufacturers to obtain an MD5 manufacturing license from the State Licensing Authority.

Key points:

• Risk Class: A (Low Risk)
• License Type: MD5 (Manufacturing License for Class A/B)
• Authority: State Licensing Authority
• Applicable Forms: MD3 for application, MD13 for test license, MD5 for final license grant

Manufacturing License Process (MD5) for Elastic Adhesive Bandage

The end-to-end MD5 license process for Elastic Adhesive Bandages includes several stages:

1. Test License Application (Form MD13): Before manufacturing, you must apply for and obtain a test license which allows product testing.
2. Product Testing: Conduct product testing at CDSCO-approved laboratories as per notified standards.
3. Documentation Preparation: Prepare comprehensive documents including Device Master File, Plant Master File, Risk Management File, and Essential Principles Checklist.
4. License Application (Form MD3): Submit the manufacturing license application along with all required documents on the CDSCO MD Online Portal.
5. Audit by Notified Body: Coordinate with an authorized notified body for the mandatory audit of your manufacturing site and quality systems.
6. Queries Resolution: Address any queries or deficiencies raised by the State Licensing Authority or the notified body promptly.
7. Grant of License (Form MD5): Upon successful compliance, the manufacturing license is granted.

For a detailed overview of the MD5 license process, refer to our comprehensive MD5 License Guide.

Manufacturing License Documents Required

To ensure a smooth application process for Elastic Adhesive Bandages, prepare the following documents meticulously:

• Company Constitution Documents: Certificate of Incorporation, Memorandum & Articles of Association
• Proof of Ownership or Tenancy of Manufacturing Premises
• Details of Technical Staff: Qualification and experience certificates
• Fire NOC and Pollution Control NOC: Compliance certificates from local authorities
• Device Master File (DMF): Detailed design, manufacturing process, and quality control information. Our Device Master File Guide can assist you.
• Plant Master File (PMF): Information about manufacturing facilities and equipment. See our Plant Master File Guide for preparation tips.
• Essential Principles Checklist: Compliance with safety and performance standards
• Risk Management File: Assessment of potential risks and mitigation strategies, aligned with ISO 14971 principles. Learn more about Risk Management.
• Test Reports: From CDSCO-approved testing laboratories. Check the Testing Laboratories List.
• Labels and Instructions for Use (IFU): As per regulatory requirements
• Quality Management System (QMS) Documents: Typically ISO 13485 certification and related SOPs

Import License Process (MD15) for Elastic Adhesive Bandage

If you are an importer of Elastic Adhesive Bandages, the import license is mandatory and falls under the Central Licensing Authority.

Key steps include:

1. Document Preparation: Gather necessary documents such as Manufacturing License, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device Master and Plant Master Files, Wholesale License, and Company Constitution.
2. Application Submission: File the license application using Form MD14 on the CDSCO MD Online Portal.
3. Queries Resolution: Respond to any departmental queries.
4. Grant of Import License (Form MD15): After satisfactory review, the license is granted.

For more detailed guidance, refer to our Import License Guide.

Import License Documents Required

The documents required for MD15 import license application include:

• Valid Manufacturing License of the product from the country of origin
• Free Sale Certificate (FSC) issued by the competent authority of the exporting country
• ISO 13485:2016 certificate
• CE Certificate or equivalent international certification
• Device Master File and Plant Master File
• Wholesale license (if applicable)
• Company Constitution and registration proof

Timeline and Processing Duration for Elastic Adhesive Bandage Licensing

The timelines may vary based on the completeness of documentation and responsiveness during query resolution. Early preparation and expert support can significantly reduce delays.

Government Fees and Costs

For Elastic Adhesive Bandages (Class A), the fee structure is as follows:

• Test License (MD13): Rs. 5,000 (approx.)
• Manufacturing License (MD5) Application Fee: Rs. 5,000 per application
• Per Product Fee: Rs. 500 per product
• Additional Costs: Testing fees at CDSCO-approved labs (varies by test scope), notified body audit fees (typically Rs. 50,000 - Rs. 1,00,000 depending on scope)

Planning your budget with these costs in mind ensures smooth financial management during licensing.

Common Challenges and Solutions

Challenge 1: Delays in product testing due to limited slots at government-approved labs.

Solution: Schedule testing in advance and consider multiple approved labs to avoid bottlenecks. Refer to the Testing Laboratories List.

Challenge 2: Incomplete or inconsistent documentation leading to repeated queries.

Solution: Engage expert consultants to prepare and review documents thoroughly before submission.

Challenge 3: Audit non-conformities related to manufacturing practices.

Solution: Conduct internal audits and gap assessments ahead of the notified body visit. Use guidance from the List of Notified Bodies for selecting certified auditors.

Expert Consultation and Support

With over 25 years of experience and 500+ successful CDSCO license applications, our regulatory consultancy offers end-to-end support tailored to Elastic Adhesive Bandage manufacturers and importers. From document preparation to audit facilitation and query management, we ensure your journey is hassle-free and compliant.

Our expertise includes:

• Detailed gap analysis and compliance roadmap
• Device Master File and Plant Master File preparation
• Coordination with notified bodies and testing labs
• Application filing on the CDSCO MD Online Portal
• Post-license regulatory support

Getting Started with Your CDSCO License Application for Elastic Adhesive Bandage

To initiate your licensing process, follow these practical steps:

1. Classify Your Device: Confirm your device as Class A using the official Medical Device Classification tool.
2. Prepare Documentation: Start compiling all mandatory documents, focusing first on the Device Master File and Plant Master File.
3. Apply for Test License (MD13): Submit your test license application via the CDSCO MD Online Portal.
4. Plan Product Testing: Coordinate with CDSCO-approved labs early to schedule testing.
5. Engage a Notified Body: Choose an authorized notified body from the Notified Bodies List for your audit.
6. Submit Manufacturing License Application (MD3): After successful testing, file your manufacturing license application.
7. Prepare for Audit: Ensure your facility and QMS are audit-ready.
8. Resolve Queries Promptly: Respond to any regulatory queries without delay.

By following these steps and leveraging expert guidance, you can achieve timely approval for your Elastic Adhesive Bandage manufacturing license and confidently enter the Indian market.

For personalized assistance, contact our regulatory experts to streamline your CDSCO licensing journey.