CDSCO License for Crutches
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
Crutches helps to transfer load from the legs to the upper body. This is useful for people who cannot use their legs to fully support the weight of their body, due to temporary or permanent disabilities.
Comprehensive Guide to CDSCO Licensing for Class A Medical Device: Crutches
Crutches are essential rehabilitation devices designed to transfer load from the legs to the upper body, aiding individuals with temporary or permanent mobility impairments. As a Class A medical device under Indian regulations, crutches fall under the lowest risk category but still require strict adherence to CDSCO licensing protocols to ensure safety and compliance.
With over 25 years of expertise and having supported 500+ manufacturers and importers, we provide a step-by-step roadmap for obtaining your CDSCO license efficiently.
CDSCO Regulatory Framework for Crutches
The Central Drugs Standard Control Organization (CDSCO) governs the import, manufacture, and sale of medical devices in India. Since crutches are notified under File No. 29/Misc./03/2020-DC (160), dated 04.08.2022, they fall under rehabilitation devices regulated as Class A medical devices.
Manufacturers and importers must comply with the Medical Device Rules, 2017, and follow the prescribed licensing process to legally market crutches in India.
Risk Classification and License Requirements for Crutches
Medical devices in India are classified into four risk categories: Class A (low risk), B, C, and D (high risk). Crutches, being Class A, require an MD5 manufacturing license issued by the State Licensing Authority.
Key points:
- Risk Class: A (Low risk)
- License Type: MD5 (Manufacturing License)
- Application Form: MD3
- Authority: State Licensing Authority
For import, an MD15 license from the Central Licensing Authority is required, but this guide focuses primarily on manufacturing licensing.
Manufacturing License Process for Crutches (MD5)
The MD5 license process for Class A devices like crutches involves the following sequential steps:
Test License (Form MD13): Obtain a test license allowing production for testing purposes. This takes approximately 1.5-2 months.
Product Testing: Get your crutches tested at government-approved testing laboratories for compliance to applicable standards. This step is crucial to demonstrate safety and efficacy.
Document Preparation: Compile all required documentation including Device Master File, Plant Master File, and quality management system protocols.
License Application Submission (Form MD3): Apply for the MD5 manufacturing license through the CDSCO MD Online Portal.
Audit by Notified Body: Undergo an audit by a notified body listed here to assess compliance with Good Manufacturing Practices (GMP).
Query Resolution: Address any queries raised by the licensing authority or the notified body.
License Grant (Form MD5): Upon successful completion, the MD5 manufacturing license will be granted.
Manufacturing License Documents Required for Crutches
To ensure a smooth application, prepare the following documents meticulously:
- Company Constitution (Memorandum of Association/Partnership Deed)
- Proof of ownership or lease agreement of manufacturing premises
- Details and qualifications of technical staff
- Fire NOC and Pollution Control Board NOC
- Device Master File
- Plant Master File
- Essential Principles Checklist confirming compliance with Indian Medical Device Rules
- Risk Management File demonstrating hazard identification and mitigation for crutches (Risk Management Guide)
- Test Reports from approved laboratories (List of Testing Laboratories)
- Product labels and Instructions for Use (IFU)
- Quality Management System (QMS) documents, preferably ISO 13485:2016 certification or equivalent
Ensuring all these documents are complete and accurate significantly reduces processing delays.
Import License Process for Crutches (MD15)
For companies planning to import crutches, an MD15 import license from the Central Licensing Authority is mandatory. The process includes:
- Preparing comprehensive documentation including your manufacturing license, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device and Plant Master Files, Wholesale License, and Company Constitution.
- Submitting the application via the CDSCO MD Online Portal.
- Addressing any queries raised.
- Awaiting license grant within 5-6 months.
Import license fees are higher compared to manufacturing and vary depending on the device class.
Timeline and Processing Duration
| Stage | Duration |
|---|---|
| Test License (MD13) | 1.5 - 2 months |
| Product Testing | 2 - 3 weeks (lab dependent) |
| Document Preparation | 2 - 3 weeks |
| License Application Processing | 1 - 1.5 months |
| Audit and Query Resolution | 3 - 4 weeks |
| Total Approximate Time | 3 - 4 months |
We recommend starting the test license application early to avoid bottlenecks.
Government Fees and Costs for Crutches MD5 License
- Application Fee: Rs. 5,000 per application
- Per Product Fee: Rs. 500 per product
These fees are payable online during application submission. Budget for additional costs such as testing laboratory fees (~Rs. 50,000 to Rs. 1,00,000 depending on tests), notified body audit fees, and consulting if required.
Common Challenges and Practical Solutions
Challenge 1: Delays in Test License Approval
Solution: Monitor your application status regularly on the CDSCO MD Online Portal and respond promptly to queries.
Challenge 2: Incomplete or Inaccurate Documentation
Solution: Use checklists and templates for Device and Plant Master Files. Our Device Master File Guide can simplify this step.
Challenge 3: Not Meeting Audit Requirements
Solution: Conduct internal audits prior to notified body visits. Engage experienced consultants to pre-assess your quality systems.
Challenge 4: Product Testing Rejections
Solution: Choose government-approved labs with experience in rehabilitation device testing. Understand testing standards thoroughly.
Expert Consultation and Support
Given the regulatory complexities and evolving guidelines, partnering with an experienced regulatory consultant can streamline your license acquisition. Our team has successfully guided 500+ companies through the CDSCO licensing maze, minimizing risks and expediting approvals.
We help with:
- End-to-end documentation preparation
- Liaison with CDSCO authorities
- Coordinating testing and audits
- Post-license compliance support
Getting Started with Your CDSCO License Application for Crutches
Register on the CDSCO MD Online Portal: Create your company profile at https://cdscomdonline.gov.in/.
Apply for Test License (Form MD13): This is the mandatory first step to initiate manufacturing for testing.
Schedule Product Testing: Identify and book government-approved labs early to avoid delays.
Prepare Required Documents: Leverage our master file guides and checklist templates.
Engage Notified Body: Select an auditor from the list of notified bodies and plan your GMP audit.
Submit MD5 License Application: Complete and submit Form MD3 after successful testing and audit.
Track Application and Respond Promptly: Monitor your application status online and address any queries immediately.
Receive License and Commence Manufacturing: Once granted, ensure continuous compliance with CDSCO regulations.
Embarking on this process with clear timelines, thorough preparation, and expert guidance significantly enhances your chances for a smooth, timely CDSCO license for crutches. Contact us to leverage our 25+ years of expertise and navigate the regulatory pathway confidently.
By adhering to these detailed steps and recommendations, manufacturers and importers can successfully bring crutches into the Indian healthcare market, improving patient mobility and quality of life with confidence and compliance.
