CDSCO License for Neonatal kangaroo care garment
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-sterile, upper body garment intended to allow a parent to safely carry/support their premature, dysmature, and/or sick infant in a manner which enables skin-to-skin contact between parent and infant (kangaroo care). It typically consists of a wrap/sweater with a variety of straps, and pockets to accommodate ventilation, monitoring, feeding, and warming devices. This is a reusable garment.
Introduction to Neonatal Kangaroo Care Garment and Regulatory Importance
The Neonatal Kangaroo Care Garment is a vital pediatric medical device designed to facilitate skin-to-skin contact between parents and their premature or sick infants. This non-sterile, reusable upper-body garment supports safe carrying while accommodating essential medical apparatus such as ventilators and monitors. Given its critical role in neonatal care, obtaining the appropriate regulatory clearance from the Central Drugs Standard Control Organization (CDSCO) is essential for manufacturers and importers aiming to market this device in India.
Navigating the CDSCO licensing process can be complex, especially for first-time applicants. With over 25 years of experience and having assisted 500+ companies in achieving regulatory compliance, we provide comprehensive insights to help you secure your CDSCO license swiftly and efficiently.
CDSCO Regulatory Framework for Neonatal Kangaroo Care Garment
As per the CDSCO guidelines, the Neonatal Kangaroo Care Garment falls under the Pediatrics and Neonatology category and is classified as a Class A medical device, which denotes a low-risk category. This classification determines the type of license required and the regulatory pathway to follow. The device is regulated under the Medical Device Rules (MDR) 2017, and compliance with these rules ensures market access and patient safety.
For Class A devices like the Kangaroo Care Garment, the license is granted by the State Licensing Authority under the MD5 license framework.
Risk Classification and License Requirements
The Neonatal Kangaroo Care Garment's classification as a Class A device means it is considered low risk, but adherence to quality and safety standards remains paramount. The risk classification dictates that manufacturers must obtain an MD5 license (manufacturing license for Class A and B devices).
Key Points:
- Risk Class: A
- License Required: MD5 License (Form MD3 application)
- Regulatory Authority: State Licensing Authority
- Reference Notification: File No. 29/MiscJ03/2020-DC (150), dated 23.08.2021
For a deeper dive into device classification, you can consult the Medical Device Classification guide.
Manufacturing License Process (MD5)
Securing an MD5 manufacturing license involves several critical steps:
Test License (Form MD13): Initially, you must apply for a test license, which typically takes about 1.5 to 2 months. This license allows you to manufacture the device for testing purposes.
Product Testing: Conduct product testing at CDSCO-approved government laboratories. Tests verify compliance with essential performance and safety parameters. You can find a list of CDSCO-approved testing laboratories here.
Document Preparation: Assemble all required documentation, including technical files, quality management system (QMS) documents, and proof of premises.
License Application (Form MD3): Submit the manufacturing license application through the CDSCO MD Online Portal.
Audit by Notified Body: A notified body will audit your manufacturing facility. Check the list of notified bodies to select an appropriate auditor.
Query Resolution: Address any queries raised by the licensing authority or notified body promptly.
License Grant: Upon successful audit and document verification, the MD5 license is issued.
The entire process generally takes 3 to 4 months.
For detailed guidance, explore our comprehensive MD5 License Guide.
Manufacturing License Documents Required
To streamline your application, ensure you have the following documentation ready:
- Company Constitution: Incorporation certificate, memorandum, and articles of association.
- Proof of Ownership or Lease of Premises: Rent agreement or ownership documents.
- Technical Staff Documents: Qualification certificates and experience proof of key personnel.
- Fire NOC: No-objection certificate from the fire department.
- Pollution Control NOC: Clearance certificate from pollution control authorities.
- Device Master File (DMF): Detailed technical specifications and design data for the garment. Refer to our Device Master File guide for best practices.
- Plant Master File (PMF): Details of manufacturing processes and quality control measures. Our Plant Master File guide can assist you.
- Essential Principles Checklist: Compliance checklist aligned with MDR 2017.
- Risk Management File: Documentation of identified risks and mitigation strategies. Learn more about Risk Management.
- Test Reports: Certificates from CDSCO-approved laboratories.
- Labels and Instructions for Use (IFU): Compliant labeling and user manuals.
- Quality Management System (QMS) Documents: ISO 13485 certification and SOPs.
Ensuring completeness and accuracy of these documents significantly reduces processing delays.
Import License Process (MD15)
If you are an importer of the Neonatal Kangaroo Care Garment, the relevant license is the MD15 import license, issued by the Central Licensing Authority.
Key steps for MD15 license:
- Document Preparation: Compile necessary documents such as manufacturing license of the exporter, Free Sale Certificate, ISO 13485:2016 certification, CE marking, DMF and PMF, and wholesale license.
- Application Submission: File your application via the CDSCO MD Online Portal using Form MD14.
- Query Resolution: Address any clarifications from the licensing authority.
- Grant of License: After review, the MD15 license is issued.
The import license process typically spans 5 to 6 months.
For a detailed walkthrough, consult our Import License Guide.
Import License Documents Required
Essential documentation for import license application includes:
- Manufacturing License of the foreign manufacturer
- Free Sale Certificate from the country of origin
- ISO 13485:2016 certification
- CE Certificate or equivalent
- Device Master File and Plant Master File
- Wholesale license of the importer
- Company Constitution and registration
Timeline and Processing Duration
| License Type | Processing Time |
|---|---|
| Test License (MD13) | 1.5 to 2 months |
| MD5 Manufacturing License | 3 to 4 months (including test license and audit) |
| MD15 Import License | 5 to 6 months |
Planning your project timeline around these durations is crucial to avoid market entry delays.
Government Fees and Costs
For the Neonatal Kangaroo Care Garment (Class A device), the fees are as follows:
- MD5 License Application Fee: Rs 5,000 per application
- Product-wise Fee: Rs 500 per product
Additional costs include expenses for testing, notified body audits, and documentation preparation.
Our practical experience suggests budgeting an extra 20-30% for unforeseen regulatory expenses.
Common Challenges and Solutions
Challenge: Delays in document verification and audit scheduling.
Solution: Prepare a thorough documentation checklist and proactively schedule audits with notified bodies well in advance.
Challenge: Non-compliance during product testing.
Solution: Conduct pre-testing audits and internal quality checks to ensure readiness.
Challenge: Misclassification of device risk leading to incorrect license applications.
Solution: Consult the official CDSCO classification or seek expert advice early in the process.
Expert Consultation and Support
Given the intricate regulatory landscape, engaging with experienced consultants can expedite approvals and mitigate compliance risks. Our team has supported over 500 companies, providing:
- Comprehensive gap analysis
- Document preparation assistance
- Liaison with CDSCO authorities and notified bodies
- Post-approval compliance training
Getting Started with Your CDSCO License Application
Assess Your Device Classification: Confirm the Neonatal Kangaroo Care Garment as Class A.
Prepare Documentation: Begin compiling your Company Constitution, Device Master File, Plant Master File, and QMS documents.
Apply for Test License (MD13): Submit via the CDSCO MD Online Portal.
Schedule Product Testing: Coordinate with CDSCO-approved laboratories early.
Engage a Notified Body: Select from the list of notified bodies for the audit.
Submit MD5 Application (Form MD3): After successful testing and audit readiness.
Address Queries Promptly: Maintain open communication with authorities to avoid delays.
Embarking on this process with a clear roadmap and expert guidance will enhance your chances of timely approval and successful market entry.
For personalized assistance, feel free to reach out to our regulatory experts who specialize in pediatric and neonatal medical devices.
