CDSCO License for Therapeutic medical binder.

Comprehensive Guide to CDSCO Licensing for Therapeutic Medical Binder (Class A)

Navigating the regulatory landscape for medical devices in India can be complex, especially for manufacturers and importers aiming to introduce devices like the Therapeutic Medical Binder. This device, classified as Class A under the CDSCO framework, serves crucial medical purposes such as providing support to body parts or holding dressings securely in place. At our consultancy, with over 25 years of experience and having assisted 500+ companies, we provide you with an expert, step-by-step approach to securing your CDSCO license efficiently.

Understanding the Therapeutic Medical Binder and Its Regulatory Importance

The Therapeutic Medical Binder is categorized under General Hospital or Orthopaedic Instruments and is notified as per Notification No. 29/Misc./03/2020-DC (193)- Part-3 dated 16.03.2022. The device’s intended use—to support body parts like the abdomen, breast, or perineal area or to hold dressings—qualifies it as a low-risk medical device, falling under Class A as per CDSCO classification.

Regulatory approval from CDSCO is mandatory before marketing or manufacturing this device in India. Compliance ensures patient safety, market credibility, and legal adherence.

CDSCO Regulatory Framework for Therapeutic Medical Binder

CDSCO regulates medical devices in India based on risk classification. Class A devices are considered low risk and thus subject to a relatively streamlined process managed by the State Licensing Authority. The licensing process for manufacturing is primarily governed under the MD5 licensing scheme (Application Form MD3), while importers must obtain the MD15 license from the Central Licensing Authority.

Risk Classification and License Requirements

The Therapeutic Medical Binder, classified as Class A, requires the following:

Manufacturing License: MD5 license from the State Authority
Import License: MD15 license from the Central Authority

For Class A devices, the MD5 license process is comprehensive yet accessible, typically completed within 3-4 months.

Manufacturing License Process (MD5 License)

The MD5 licensing process involves several key steps:

Test License (Form MD13): Before applying for the MD5 license, manufacturers must obtain a test license which takes approximately 1.5-2 months.
Product Testing: Conduct mandatory product testing through government-approved laboratories to validate safety and performance. A complete list of Testing Laboratories is available on the CDSCO MD Online portal.
Document Preparation: Compile all required documents including Device Master File, Plant Master File, Risk Management File, and others.
Application Submission: Submit the application for the MD5 license through the CDSCO MD Online Portal.
Audit by Notified Body: An audit is conducted by a notified body listed on the CDSCO site. You can check the list of notified bodies to select an appropriate auditor.
Query Resolution: Address any queries raised by the department or the notified body promptly.
License Grant: Upon successful completion of all steps, the MD5 license will be granted on Form MD5.

For a thorough understanding, refer to our detailed MD5 License Guide.

Manufacturing License Documents Required

To ensure a smooth approval process, prepare the following documents meticulously:

Company Constitution (Incorporation Certificate, Partnership Deed, etc.)
Proof of Ownership or Rent Agreement of Manufacturing Premises
Details and Qualification Documents of Technical Staff
Fire No Objection Certificate (NOC)
Pollution Control Board NOC
Device Master File (DMF) detailing device specifications and design (Device Master File Guide)
Plant Master File (PMF) outlining manufacturing facilities (Plant Master File Guide)
Essential Principles Checklist confirming compliance with applicable standards
Risk Management File demonstrating risk mitigation strategies (Risk Management)
Test Reports from government-approved labs
Product Labels and Instructions for Use (IFU)
Quality Management System (QMS) documents such as ISO 13485 certification

Import License Process (MD15 License)

While your Therapeutic Medical Binder is Class A, importers must apply for the MD15 license from the Central Licensing Authority. This process involves:

Document Preparation: Including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate, and other core documents.
Application Submission: Apply via the CDSCO MD Online Portal.
Query Resolution: Respond to departmental queries.
License Issuance: The license is granted on Form MD15.

The process typically spans 5-6 months due to thorough evaluation.

Refer to our comprehensive Import License Guide for more details.

Import License Documents Required

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

Timeline and Processing Duration

Process Step	Duration
Test License (MD13)	1.5 - 2 months
Product Testing	1 - 1.5 months
Document Preparation	2 - 3 weeks
MD5 License Application	Submission & Audit
Audit & Query Resolution	1 - 1.5 months
Total Time	3 - 4 months

Adhering to timelines and proactive query resolution can help you avoid delays.

Government Fees and Costs

For the Therapeutic Medical Binder (Class A), the fee structure is as follows:

Application Fee: INR 5,000 per application
Product Fee: INR 500 per product

Additional costs include testing fees charged by government-approved labs and audit fees payable to notified bodies.

Common Challenges and Solutions

Challenge 1: Delays in obtaining test license and product testing.

Solution: Initiate test license application early and select accredited labs with shorter turnaround times.

Challenge 2: Incomplete or inconsistent documentation.

Solution: Utilize checklists and expert reviews to ensure completeness and accuracy.

Challenge 3: Audit non-compliance due to gaps in QMS or facility.

Solution: Conduct internal audits and training before notified body assessment.

Challenge 4: Slow query resolution from CDSCO.

Solution: Maintain clear, prompt communication and submit comprehensive responses.

Expert Consultation and Support

With over two decades of expertise and having supported over 500 medical device manufacturers and importers, we offer tailored guidance throughout your licensing journey. From document preparation, audit readiness, to post-approval compliance, our team ensures your Therapeutic Medical Binder enters the Indian market without regulatory hurdles.

Getting Started with Your CDSCO License Application

Step 1: Register your organization on the CDSCO MD Online Portal.
Step 2: Initiate your test license application (Form MD13) early to avoid bottlenecks.
Step 3: Engage with a notified body from the official list of notified bodies to schedule your audit.
Step 4: Prepare all necessary documentation (Device Master File, Plant Master File, Risk Management, etc.) with expert assistance.
Step 5: Submit your MD5 license application on the portal and track progress diligently.

Starting early, staying organized, and seeking expert help can reduce your approval time and cost significantly. Contact us to leverage our experience and expedite your CDSCO licensing for your Therapeutic Medical Binder.

By following this guide, manufacturers and importers will be well-positioned to navigate the CDSCO regulatory process effectively, ensuring timely market access and compliance for their Therapeutic Medical Binder devices.

CDSCO License for Therapeutic medical binder.

Medical Device Information

Important Notice for Class A Devices

Intended Use