CDSCO License for Infant limb 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 non-rigid device, usually made of a fabric and/or plastic materials, used to temporarily render parts of an infant's body immovable, e.g., the arms and/or feet while the patient undergoes therapeutic or diagnostic interventions. It will typically be used to prevent the patient from interrupting an intravenous (IV) infusion, pulling out a catheter, or interfering with wound care. This is a reusable device.
Comprehensive Guide to CDSCO Licensing for Infant Limb Immobilizer (Reusable) - Class A Medical Device
Introduction: Understanding the Infant Limb Immobilizer and Its Regulatory Importance
The Infant Limb Immobilizer, designed for pediatric and neonatology use, is a reusable device intended to temporarily immobilize infant limbs to prevent interference with therapeutic or diagnostic procedures. Given its critical role in ensuring patient safety during intravenous infusions, catheter care, and wound management, stringent regulatory compliance is essential. As a Class A medical device under CDSCO regulations, the Infant Limb Immobilizer mandates obtaining a manufacturing or import license to legally enter the Indian market.
With over 25 years of experience and having assisted 500+ companies in navigating the CDSCO licensing landscape, we provide you with a detailed roadmap to secure your MD5 manufacturing license efficiently.
CDSCO Regulatory Framework for Infant Limb Immobilizer (Reusable)
The Central Drugs Standard Control Organization (CDSCO) governs the regulatory framework for medical devices in India. The Infant Limb Immobilizer falls under the Class A (low risk) category as per CDSCO’s risk classification system. This classification impacts the licensing authority, documentation, audit requirements, and timelines.
The regulatory process for Class A devices is managed primarily by the State Licensing Authority through the MD5 license application (Form MD3). To ensure compliance:
- Manufacturers must obtain a test license (Form MD13) before applying for the manufacturing license.
- Product testing must be conducted at CDSCO-approved laboratories.
- An audit by a notified body is mandatory to assess QMS and manufacturing compliance.
You can submit all applications and track the status through the CDSCO MD Online Portal.
Risk Classification and License Requirements for Infant Limb Immobilizer
The Infant Limb Immobilizer is classified as a Class A device due to its low-risk profile:
- Risk Class: A (Low Risk)
- License Required: MD5 Manufacturing License (Form MD3)
- Authority: State Licensing Authority
Understanding the risk classification is vital as it determines the licensing process, fees, and timelines.
Manufacturing License Process (MD5) for Infant Limb Immobilizer
The manufacturing license process for Class A devices such as the Infant Limb Immobilizer involves several key steps:
- Test License Application (Form MD13): Apply for a test license which allows sample product testing.
- Product Testing: Get the device tested at CDSCO-approved laboratories. Approved testing labs can be found on the CDSCO Testing Laboratories list.
- Documentation Preparation: Compile all required documents including Device Master File, Plant Master File, Risk Management File, and Quality Management System (QMS) documents.
- Application for MD5 License (Form MD3): Submit the application along with the audit report.
- Audit by Notified Body: A notified body conducts an on-site audit; you can check the list of notified bodies here.
- Query Resolution: Address any queries raised by the State Licensing Authority or notified body.
- License Grant: Upon satisfactory review, the MD5 license is issued.
The entire process typically takes 3 to 4 months from test license application to license grant.
Manufacturing License Documents Required for Infant Limb Immobilizer
Accurate and complete documentation is crucial to avoid delays. For the Infant Limb Immobilizer, you must prepare the following:
- Company Constitution Documents: Certificate of Incorporation, Memorandum & Articles of Association
- Proof of Ownership or Lease of Manufacturing Premises
- Technical Staff Details: Qualification certificates and experience
- No-Objection Certificates (NOCs): Fire and Pollution NOCs
- Device Master File (DMF): Detailed device description, specifications, manufacturing process, and validation. Refer to our Device Master File guide.
- Plant Master File (PMF): Details of manufacturing site, infrastructure, equipment, and utilities. For help, review our Plant Master File guide.
- Essential Principles Checklist: Compliance with Indian Medical Device Rules
- Risk Management File: Hazard analysis and mitigation strategies as per ISO 14971. Learn more at our Risk Management resource.
- Product Test Reports: From CDSCO-approved labs
- Labels and Instructions for Use (IFU): As per regulatory requirements
- Quality Management System (QMS) Documents: ISO 13485 certification and internal SOPs
Import License Process (MD15) for Infant Limb Immobilizer
If you plan to import the Infant Limb Immobilizer into India, the MD15 import license is mandatory. This process is managed by the Central Licensing Authority and generally takes 5 to 6 months.
Key steps include:
- Preparation of import license documents (see below)
- Submission of application on the CDSCO MD Online Portal
- Resolution of queries from the authorities
- License grant on Form MD15
Unlike manufacturing, test licenses are not required for import applications.
Import License Documents Required for Infant Limb Immobilizer
Importers must submit the following documents:
- Valid Manufacturing License from the country of origin
- Free Sale Certificate from the country of origin
- ISO 13485:2016 Certification
- CE Certificate (if applicable)
- Device Master File and Plant Master File
- Wholesale License
- Company Constitution Documents
Government fees vary by device class and number of products imported.
Timeline and Processing Duration
| Process Step | Duration |
|---|---|
| Test License (Form MD13) | 1.5 to 2 months |
| Product Testing | 2 to 3 weeks (varies) |
| Audit & Documentation Review | 1 to 1.5 months |
| Query Resolution | 2 to 4 weeks |
| Total for MD5 License | 3 to 4 months approx. |
For import license (MD15), the total duration is approximately 5 to 6 months.
Government Fees and Costs
For the Infant Limb Immobilizer (Class A device):
- MD5 Manufacturing License:
- Application Fee: Rs 5,000
- Per Product Fee: Rs 500
- Test License (MD13): No separate fee mentioned but required before MD5
Additional costs include product testing fees charged by approved laboratories and notified body audit charges which vary by agency.
Common Challenges and Solutions
Challenge 1: Incomplete Documentation
- Solution: Use detailed checklists and templates for Device and Plant Master Files. Engage experts early to review documents.
Challenge 2: Delays in Product Testing
- Solution: Schedule testing with CDSCO-approved labs well in advance. Keep backup labs in consideration.
Challenge 3: Audit Non-Conformities
- Solution: Conduct internal audits and gap assessments before notified body audits. Address QMS weaknesses proactively.
Challenge 4: Query Management
- Solution: Respond promptly with clear, evidence-backed explanations. Maintain open communication with licensing authorities.
Expert Consultation and Support
Navigating CDSCO licensing can be complex. Our 25+ years of experience have equipped us to assist manufacturers and importers with:
- Preparing robust Device and Plant Master Files
- Coordinating product testing and audit schedules
- Liaising with CDSCO and notified bodies
- Streamlining document submissions and query responses
Our proven track record includes supporting over 500 companies in securing timely licenses for pediatric medical devices like the Infant Limb Immobilizer.
Getting Started with Your CDSCO License Application
To initiate your licensing journey for the Infant Limb Immobilizer:
- Register on the CDSCO MD Online Portal: Create your account and familiarize yourself with the platform.
- Prepare Test License Application (Form MD13): Gather preliminary documents and submit the test license application.
- Plan Product Testing: Identify and coordinate with CDSCO-approved testing laboratories.
- Develop Master Files and QMS Documents: Use our comprehensive guides to compile accurate and compliant documents.
- Engage a Notified Body Early: Schedule your audit to align with license application timelines.
- Submit MD5 License Application (Form MD3): Ensure all test reports and audit certificates are in place.
Starting early and maintaining organized documentation will significantly reduce approval timelines.
For personalized assistance and to ensure a seamless licensing process, contact our expert regulatory consultants today. With our experience and dedication, we make your regulatory journey straightforward and successful.
