CDSCO License for Infant whole-body immobilizer, reusable
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 device intended to be used to temporarily render an infant's whole body immovable (strait-jacket effect) while the patient undergoes therapeutic or diagnostic interventions. It includes non-rigid fabric and/or plastic components but might also include a rigid structural component (e.g., board). This is a reusable device.
Comprehensive Guide to CDSCO Licensing for Infant Whole-Body Immobilizer (Reusable) - Class A Medical Device
As specialists with over 25 years of experience in medical device regulatory affairs and having supported 500+ companies in acquiring CDSCO licenses, we understand the nuanced requirements for devices like the Infant Whole-Body Immobilizer (reusable). This Class A pediatric device plays a crucial role in safely immobilizing infants during therapeutic or diagnostic procedures, ensuring patient safety and procedural accuracy.
Understanding the Infant Whole-Body Immobilizer and Its Regulatory Importance
The Infant Whole-Body Immobilizer is designed to temporarily restrict an infant's body movement, often referred to as a "strait-jacket effect." It may comprise non-rigid fabric, plastic components, and sometimes a rigid structural board, making it reusable and critical in Neonatology and Pediatrics. Due to its intended use and contact with patients, it falls under Class A risk category as per CDSCO classification.
Obtaining a valid CDSCO license is mandatory for manufacturing or importing this device in India, ensuring compliance with quality, safety, and efficacy standards. Without proper licensing, manufacturers or importers cannot legally market this device.
CDSCO Regulatory Framework for Infant Whole-Body Immobilizer (Class A Device)
The Central Drugs Standard Control Organization (CDSCO) regulates all medical devices in India under the Medical Device Rules (MDR) 2017. For Class A devices like the Infant Whole-Body Immobilizer, the licensing responsibility lies with the State Licensing Authority through an MD5 license.
This regulatory framework mandates:
- Compliance with Essential Principles of Safety and Performance
- Implementation of a Quality Management System (QMS), usually ISO 13485:2016
- Submission of Device Master File (DMF) and Plant Master File (PMF)
- Passing product testing through government-approved laboratories
- Successful audit by notified bodies accredited by CDSCO
Risk Classification and License Requirements for Infant Whole-Body Immobilizer
As a Class A device, the Infant Whole-Body Immobilizer requires an MD5 Manufacturing License issued by the State Licensing Authority. This license confirms your facility meets all manufacturing and quality standards to produce safe and effective medical devices.
You will need to follow a stepwise process involving:
- Obtaining a Test License (Form MD13)
- Product testing at CDSCO-approved labs
- Preparing comprehensive documentation
- Applying for MD5 license (Form MD3)
- Undergoing notified body audit
- Resolving any queries
- Final grant of license (Form MD5)
For detailed classification and guidance, refer to our Medical Device Classification resource.
Step-by-Step Manufacturing License Process (MD5) for Infant Whole-Body Immobilizer
Apply for Test License (Form MD13):
- Duration: Approximately 1.5 to 2 months
- Purpose: To obtain permission to manufacture and test the device samples
Product Testing:
- Conduct testing at government-approved labs listed on the CDSCO Testing Laboratories portal
- Testing typically includes biocompatibility, material safety, and mechanical integrity
Documentation Preparation:
- Compile Device Master File, Plant Master File, Risk Management File, Essential Principles checklist, Quality Management System documentation, and other technical files
Submit MD5 License Application (Form MD3):
- Application submitted via the CDSCO MD Online Portal
- Include test license, test reports, and all mandatory documents
Audit by Notified Body:
- Schedule audit with a notified body from the CDSCO Notified Bodies list
- Audit covers manufacturing facility, QMS, and compliance with MDR
Resolution of Queries:
- Respond promptly and comprehensively to any queries from CDSCO or the notified body
Grant of MD5 License (Form MD5):
- Upon satisfactory audit and document review, the license is issued
For a detailed overview of the MD5 license process, please consult our MD5 License Guide.
Manufacturing License Documents Required for Infant Whole-Body Immobilizer
To streamline your application, prepare the following documents meticulously:
- Company Constitution: Incorporation certificate, partnership deed, or LLP agreement
- Proof of Ownership or Lease of Premises: Sale deed, rent agreement with NOC
- Technical Staff Qualification Documents: CVs and certificates of competent personnel
- Fire NOC & Pollution Control NOC: From respective local authorities
- Device Master File (DMF): Detailed device description, specifications, manufacturing process, and validation
- Plant Master File (PMF): Infrastructure, equipment, quality control systems
- Essential Principles Checklist: Compliance summary as per MDR
- Risk Management File: Hazard analysis, risk control measures, and post-market surveillance plan
- Test Reports: From government-approved laboratories
- Labels and Instructions for Use (IFU): Drafts demonstrating compliance with labeling regulations
- Quality Management System Documents: ISO 13485:2016 certification and internal procedures
Our comprehensive Device Master File guide and Plant Master File guide can assist in preparing these critical documents.
Import License Process (MD15) for Infant Whole-Body Immobilizer
Though primarily focused on manufacturing, if you are importing this device, an MD15 Import License from CDSCO's Central Licensing Authority is mandatory. The application involves:
- Preparation of required documents including manufacturing license, Free Sale Certificate, ISO 13485:2016, CE Certificate
- Submission via the CDSCO MD Online Portal
- Resolution of any queries
The import license timeline generally extends to 5-6 months. For a detailed import process, see our Import License Guide.
Timeline and Processing Duration for Infant Whole-Body Immobilizer Licensing
| Stage | Duration |
|---|---|
| Test License (MD13) | 1.5 – 2 months |
| Product Testing | 3 – 4 weeks |
| Documentation Preparation | Variable (2 – 4 weeks recommended) |
| MD5 Application Processing | 1 – 2 months |
| Notified Body Audit | 2 – 3 weeks |
| Query Resolution and Final Grant | 2 – 3 weeks |
Total Time: Approximately 3 to 4 months from test license application to grant of MD5 license.
Government Fees and Costs for MD5 License
- Application Fee: ₹5,000 per application
- Product Fee: ₹500 per product (each variant/model)
Additional costs include:
- Testing laboratory fees (varies by test scope)
- Notified body audit fees (typically ₹50,000 – ₹1,00,000 depending on scope)
- Consultant fees if you engage professional help
Transparent budgeting and planning for these expenses will help avoid delays.
Common Challenges and Practical Solutions
- Delayed Test Reports: Engage with CDSCO-approved labs early and confirm their testing timelines.
- Incomplete Documentation: Use checklists and templates from trusted guides to ensure completeness.
- Audit Non-conformities: Conduct pre-audit internal reviews and mock audits.
- Query Delays: Prepare prompt, evidence-backed responses to CDSCO queries.
Our extensive experience allows us to anticipate and mitigate these issues effectively.
Expert Consultation and Support for Your Licensing Journey
Navigating the CDSCO licensing process for pediatric Class A devices can be complex. We offer tailored consultancy:
- Document preparation support
- Liaison with CDSCO and notified bodies
- Pre-audit readiness reviews
- Regulatory strategy and compliance planning
Partnering with experts significantly increases your chances of timely license approval.
Getting Started with Your CDSCO License Application for Infant Whole-Body Immobilizer
- Assess your device classification and confirm the license type (MD5 for Class A).
- Gather your technical and legal documents as per the checklist above.
- Apply for the Test License (MD13) through the CDSCO MD Online Portal.
- Coordinate product testing with a government-approved laboratory.
- Prepare comprehensive device and plant master files.
- Submit your manufacturing license application (Form MD3) once testing is complete.
- Schedule and prepare for the notified body audit.
- Respond promptly to any queries raised during the review.
Starting early and maintaining clear documentation practices can streamline your path to market. For personalized assistance or detailed queries, connect with our regulatory experts who have successfully guided over 500 companies through this process.
Embark on your licensing journey confidently with trusted expertise ensuring compliance and market access for your Infant Whole-Body Immobilizer in India.
