CDSCO License for Infant limb immobilizer, single- use
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 single-use device.
Comprehensive Guide to CDSCO Licensing for Infant Limb Immobilizer (Class A Medical Device)
As a medical device manufacturer or importer aiming to introduce the Infant Limb Immobilizer—a single-use, non-rigid device designed specifically for pediatrics and neonatology—into the Indian market, securing the appropriate CDSCO license is essential. This device, classified as Class A (low risk), requires adherence to regulatory frameworks designed to ensure safety, quality, and compliance.
With over 25 years of experience and having supported 500+ companies in navigating the CDSCO licensing process, we provide you with a detailed roadmap tailored specifically for the Infant Limb Immobilizer.
CDSCO Regulatory Framework for Infant Limb Immobilizer
The Central Drugs Standard Control Organization (CDSCO) governs the import and manufacture of medical devices in India under the Medical Device Rules, 2017. Your Infant Limb Immobilizer falls under Class A, indicating a low-risk device category.
Per CDSCO guidelines, Class A devices are regulated by the State Licensing Authority, and manufacturers need to secure the MD5 manufacturing license (application on Form MD3). Importers must apply for the MD15 import license if bringing this device into India.
This regulatory framework ensures that all medical devices meet the Essential Principles of safety and performance, with appropriate documentation, testing, and quality management systems in place.
Risk Classification and License Requirements for Infant Limb Immobilizer
- Risk Class: Class A
- Regulatory Authority: State Licensing Authority
- License Type for Manufacture: MD5 (Application Form MD3)
- License Type for Import: MD15 (Application Form MD14)
Class A devices require a test license (MD13) before full manufacturing license issuance. This test license allows you to produce limited quantities for testing and validation.
For detailed classification criteria, you can refer to the Medical Device Classification guide.
Manufacturing License Process (MD5) for Infant Limb Immobilizer
Obtaining the MD5 manufacturing license involves several well-defined steps:
Apply for MD13 Test License: Submit an application for the test license on Form MD13 via the CDSCO MD Online Portal. This license permits manufacturing of limited units for testing.
Product Testing: Conduct product testing at CDSCO-approved laboratories. Testing ensures compliance with safety and performance standards. You can find a list of Testing Laboratories approved by CDSCO.
Document Preparation: Compile essential documents such as Device Master File, Plant Master File, Essential Principles Checklist, Risk Management File, and Quality Management System (QMS) documents.
Application for MD5 License: Submit the manufacturing license application on Form MD3 through the CDSCO portal.
Audit by Notified Body: The State Licensing Authority will appoint a notified body to conduct a thorough audit of your manufacturing facility and QMS. A list of Notified Bodies is available for reference.
Resolution of Queries: Address any queries raised by the department or notified body promptly.
Grant of License: Upon satisfactory review and audit, the MD5 manufacturing license will be granted.
Manufacturing License Documents Required for Infant Limb Immobilizer
To ensure a smooth application process, prepare the following documents meticulously:
- Company Constitution (e.g., Certificate of Incorporation)
- Proof of ownership or lawful possession of manufacturing premises
- Details and qualifications of technical staff
- Fire NOC and Pollution Control NOC
- Device Master File (DMF): Detailed technical specifications, design, and production processes (Device Master File Guide)
- Plant Master File (PMF): Description of manufacturing facilities and quality controls (Plant Master File Guide)
- Essential Principles Checklist confirming compliance with Indian Medical Device Rules
- Risk Management File demonstrating risk analysis and mitigation (Risk Management)
- Test Reports from approved laboratories
- Product labels and Instructions for Use (IFU)
- Quality Management System documents, preferably ISO 13485:2016 certification
Import License Process (MD15) for Infant Limb Immobilizer
For importers, the MD15 license from the Central Licensing Authority is mandatory before marketing the Infant Limb Immobilizer in India.
The import license process includes:
Document Preparation: Gather necessary documents such as the manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certificate, CE certificate (if applicable), Device and Plant Master Files, wholesale license, and company constitution.
Application Submission: Submit the application on Form MD14 for MD15 license via the CDSCO MD Online Portal.
Query Resolution: Promptly address any departmental queries during the review process.
License Grant: Upon successful evaluation, the MD15 import license will be issued.
Import License Documents Required for Infant Limb Immobilizer
Key documents for import licensing include:
- Valid manufacturing license from the country of origin
- Free Sale Certificate confirming market approval
- ISO 13485:2016 certification
- CE Certificate (if marketed in Europe)
- Device Master File and Plant Master File
- Wholesale Drug License
- Company Constitution and ownership proof
Timeline and Processing Duration
| License Type | Process Duration |
|---|---|
| MD13 Test License | 1.5 to 2 months |
| MD5 Manufacturing License | 3 to 4 months (including MD13) |
| MD15 Import License | 5 to 6 months |
Typically, for your Infant Limb Immobilizer, expect the full MD5 manufacturing license process to complete in approximately 3 to 4 months, including the test license, product testing, document preparation, audit, and query resolution.
Government Fees and Costs
For Class A devices like the Infant Limb Immobilizer, the government fees are as follows:
MD5 Manufacturing License:
- Application fee: Rs 5000
- Per product fee: Rs 500
MD13 Test License:
- Fees included in MD5 process
MD15 Import License:
- Site fee: Approximately $1000
- Per product fee: $50
Budget for additional costs such as product testing fees at government-approved labs and audit expenses by notified bodies.
Common Challenges and Solutions
Delayed Testing Results: Testing in government-approved labs can be time-consuming. To mitigate this, submit samples early and choose labs with faster turnaround times.
Incomplete Documentation: Missing or inconsistent documents often lead to query delays. Use comprehensive checklists and consult guides like our Device Master File guide to ensure completeness.
Audit Non-Compliance: Prepare your facility and quality management system according to notified body expectations. Conduct internal audits beforehand.
Query Management: Quickly and accurately respond to departmental queries to avoid processing delays.
Expert Consultation and Support
Navigating CDSCO licensing can be complex. Our decades of experience and successful track record mean we provide:
- Expert review of your technical documentation
- Assistance with submission on the CDSCO MD Online Portal
- Coordination with notified bodies and labs
- Training and readiness support for audits
- Query handling and liaison with CDSCO officials
Engaging expert consultants early can significantly reduce timelines and improve approval success rates.
Getting Started with Your CDSCO License Application for Infant Limb Immobilizer
Classify Your Device: Confirm your device’s classification as Class A using official guidelines.
Prepare Documentation: Begin compiling your Device Master File, Plant Master File, Risk Management File, and QMS documents.
Apply for MD13 Test License: Initiate manufacturing authorization for testing purposes via the CDSCO portal.
Submit Samples for Testing: Send samples to CDSCO-approved labs promptly.
Plan for Audit: Engage with a notified body early, schedule pre-audit readiness checks.
Apply for MD5 Manufacturing License: Once testing completes, submit Form MD3 with all required documents.
Respond to Queries Promptly: Maintain open communication channels with CDSCO and the notified body.
By following these practical steps and leveraging expert support, manufacturers and importers of Infant Limb Immobilizers can streamline their pathway to CDSCO licensing and successful market entry.
For more detailed insights, explore our MD5 License Guide and reach out to experienced consultants who understand the nuances of pediatric device regulation in India.
