CDSCO License for Congenital hip dislocation abduction splint
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
A congenital hip dislocation abduction splint is a device intended for medical purposes to stabilize the hips of a young child with dislocated hips in an abducted position (away from the midline).
Congenital Hip Dislocation Abduction Splint: Comprehensive CDSCO Licensing Guide for Class A Medical Devices
As a trusted regulatory consultancy with over 25 years of experience and having assisted more than 500 companies, we understand the critical importance of securing the right CDSCO license to legally manufacture and market medical devices in India. This guide focuses specifically on the Congenital Hip Dislocation Abduction Splint, a Class A rehabilitation device designed to stabilize dislocated hips in infants by maintaining an abducted position.
Given its specialized medical purpose, regulatory compliance is paramount not only to meet Indian laws but also to ensure patient safety and product reliability.
CDSCO Regulatory Framework for Congenital Hip Dislocation Abduction Splints
The Central Drugs Standard Control Organization (CDSCO) is the apex regulatory authority governing medical devices in India. Post the Medical Device Rules (MDR) 2017, devices are categorized based on risk, necessitating different licensing pathways.
Your device is categorized under Class A (low risk), specifically in the rehabilitation category as per the notification File No. 29/Misc./03/2020-DC (160) dated 04.08.2022.
Manufacturers of Class A devices must obtain the MD5 Manufacturing License issued by the State Licensing Authority.
Risk Classification and License Requirements for Your Device
- Device Name: Congenital Hip Dislocation Abduction Splint
- Risk Class: A (low risk)
- Category: Rehabilitation
- Applicable License: MD5 Manufacturing License
- Governing Authority: State Licensing Authority
Class A devices are subject to a relatively streamlined licensing process but still require thorough documentation, testing, and audits to ensure compliance with all regulatory standards.
Learn more about device classification on the Medical Device Classification page.
Manufacturing License Process (MD5) for Class A Devices
The MD5 license process for your splint involves multiple stages:
Test License (Form MD13): Initially, you must obtain a test license to manufacture the device prototype for testing purposes. This typically takes 1.5 to 2 months.
Product Testing: Once the test license is granted, samples must be tested at government-approved laboratories. Refer to the Testing Laboratories for authorized centers.
Documentation Preparation: Prepare and compile the extensive documentation for the license application.
Application Submission (Form MD3): Submit the manufacturing license application for Class A devices via the CDSCO MD Online Portal.
Audit by Notified Body: A notified body will audit your manufacturing premises and systems. Consult the Notified Bodies List to select the appropriate auditor.
Resolution of Queries: Address any queries raised by CDSCO or the notified body promptly.
Grant of License (Form MD5): Upon successful completion, the State Licensing Authority grants the MD5 manufacturing license.
The entire process typically spans 3 to 4 months, assuming timely response and compliance.
For a detailed walkthrough, see our MD5 License Guide.
Manufacturing License Documents Required for Congenital Hip Dislocation Abduction Splints
To ensure your application is complete and avoids delays, prepare the following documents:
- Company Constitution (Partnership deed, Memorandum & Articles of Association)
- Proof of Ownership or Lease of Manufacturing Premises
- Technical Staff Credentials: Qualification and experience certificates of technical personnel
- Fire NOC and Pollution Control NOC
- Device Master File (DMF): Detailed product description, manufacturing process, materials used, design, and performance data. Our comprehensive Device Master File Guide can assist you.
- Plant Master File (PMF): Details of manufacturing facilities, equipment, and quality management systems. Learn more via our Plant Master File Guide.
- Essential Principles Checklist: Compliance with MDR essential principles
- Risk Management File: Hazard analysis and risk mitigation related to the device. Refer to our Risk Management resource.
- Test Reports: Results from government-approved labs confirming product safety and efficacy
- Labels and Instructions for Use (IFU): Drafts demonstrating compliance with labeling requirements
- Quality Management System (QMS) Documents: ISO 13485 certification and internal SOPs
Ensuring accuracy and completeness of these documents reduces the risk of application rejection or delays.
Import License Process (MD15) for Congenital Hip Dislocation Abduction Splints
If you intend to import this device into India, an MD15 Import License from CDSCO’s Central Licensing Authority is mandatory.
Key highlights of the import license process:
- No test license is required.
- Submit application on the CDSCO MD Online Portal using Form MD14.
- Required documents include Manufacturing License from the country of origin, Free Sale Certificate, ISO 13485:2016 certificate, CE Certificate (if applicable), Device Master File, Plant Master File, Wholesale License, and Company Constitution.
- Processing time is approximately 5 to 6 months.
- Fees vary by risk class; for Class A devices, the site fee is 50 per product.
For more details, refer to our Import License Guide.
Timeline and Processing Duration Summary
| Step | Duration |
|---|---|
| Test License (MD13) | 1.5 - 2 months |
| Product Testing | 1 month |
| Application Submission | Immediate upon docs |
| Audit and Inspection | 1 month |
| Query Resolution | 2-3 weeks |
| License Grant (MD5) | Total ~3-4 months |
Planning your application timeline with these milestones in mind helps streamline market entry.
Government Fees and Costs Breakdown
- Test License Fee: Included within application
- MD5 Manufacturing License Fee: Rs 5,000 per application
- Product Fee: Rs 500 per product
Budgeting for testing, notified body audits, and consultancy fees is also critical.
Common Challenges and Practical Solutions
Challenge 1: Delays Due to Incomplete Documentation
- Solution: Use a comprehensive document checklist early; consider professional regulatory consultation to verify completeness.
Challenge 2: Selecting Appropriate Testing Laboratories
- Solution: Always opt for CDSCO-approved labs listed on the Testing Laboratories portal.
Challenge 3: Audit Failures
- Solution: Prepare your quality management system and factory premises in advance; pre-audit mock inspections can be invaluable.
Challenge 4: Navigating Query Resolution
- Solution: Respond promptly and clearly; maintain open communication with CDSCO and notified bodies.
Expert Consultation and Support
With our extensive track record, we provide end-to-end assistance including:
- Gap analysis and readiness assessment
- Document preparation and review
- Coordination with notified bodies and testing labs
- Application submission and query handling
- Post-license compliance guidance
Our expert team ensures your congenital hip dislocation abduction splint meets all regulatory benchmarks swiftly and cost-effectively.
Getting Started with Your CDSCO License Application
Gather your internal team: Assign responsible personnel for documentation, quality, and regulatory affairs.
Preliminary Documentation: Begin compiling key documents such as your Device Master File and Plant Master File.
Initiate Test License Application: File Form MD13 via the CDSCO MD Online Portal to start the testing phase.
Schedule Testing: Coordinate with an approved testing laboratory immediately upon test license approval.
Select a Notified Body: Identify and engage a notified body from the official Notified Bodies List for your audit.
Prepare for Audit: Conduct internal pre-audit checks and rectify any compliance gaps.
Submit Manufacturing License Application: Once testing and audits are complete, submit your Form MD3 application and track status online.
Starting early and following a well-structured plan significantly reduces approval time and expenses.
For personalized assistance tailored to your congenital hip dislocation abduction splint, connect with our regulatory experts who have successfully guided over 500 manufacturers through the CDSCO licensing maze.
By following this detailed roadmap, you can confidently navigate the CDSCO regulatory landscape, ensuring your rehabilitation device reaches those in need safely and compliantly.
