CDSCO License for Infant resuscitation table
Medical Device Information
Intended Use
A flat surface fixed on legs and on which newborn infants who do not breathe spontaneously at birth and are oxygen deficient are placed for emergency resuscitation. It is typically equipped with a heating lamp and sometimes a supplemental heating pad, a low- pressure suction system, an oxygen (O2) supply, a gas mixer (oxygen/air), and a resuscitator. It may be supplied with the resuscitation devices or not, in which case the resuscitation devices are fitted by another party (e.g., hospital clinical engineer, device supplier). This device is typically fixed in one place.
Comprehensive Guide to CDSCO Licensing for Infant Resuscitation Tables (Class B Medical Device)
Infant resuscitation tables are critical pediatric and neonatology devices designed to support newborns who do not breathe spontaneously at birth. These tables provide a stable, heated surface equipped with essential life-supporting features such as oxygen supply, suction systems, and resuscitation devices. Given their vital role in emergency care, ensuring regulatory compliance via the Central Drugs Standard Control Organization (CDSCO) is paramount for manufacturers and importers aiming to market these devices in India.
Understanding the CDSCO Regulatory Framework for Infant Resuscitation Tables
As a Class B medical device, infant resuscitation tables fall under moderate risk according to the CDSCO’s classification system. The licensing and regulatory oversight for such devices are managed primarily at the State level through the MD5 manufacturing license, which mandates strict adherence to quality, safety, and performance standards.
The regulatory notification governing infant resuscitation tables is File No. 29/MiscJ03/2020-DC (150), dated August 23, 2021, which defines the device’s intended use and classification.
Risk Classification and License Requirements for Infant Resuscitation Tables
- Risk Class: B (Moderate Risk)
- Regulatory License: MD5 Manufacturing License (Form MD3)
- Issuing Authority: State Licensing Authority
Class B devices require a comprehensive process that includes product testing, documentation, audits, and compliance with the Essential Principles checklist.
Step-by-Step Manufacturing License Process (MD5) for Infant Resuscitation Tables
Test License Application (Form MD13): Initiate by applying for a test license to manufacture the device for testing and evaluation. This license typically takes 1.5 to 2 months to be granted.
Product Testing: Conduct mandatory product testing in government-approved laboratories to verify compliance with Indian standards. You can find a detailed list of approved Testing Laboratories here.
Document Preparation: Compile essential documents including Device Master File, Plant Master File, Risk Management File, and QMS documents.
MD5 License Application (Form MD3): Submit the manufacturing license application through the CDSCO MD Online Portal.
Audit by Notified Body: Undergo facility and quality system audits by a notified body. Refer to the current list of notified bodies authorized for MD5 audits.
Resolution of Queries: Address any queries or observations raised by the CDSCO or notified body promptly.
Grant of License (Form MD5): Upon successful audit and document verification, the MD5 license is issued.
Manufacturing License Documents Required for Infant Resuscitation Tables
- Constitution of the company or firm
- Proof of ownership or valid lease of manufacturing premises
- Technical staff qualifications and experience details
- Fire safety NOC
- Pollution control NOC
- Device Master File (DMF): Detailed design, specifications, and manufacturing process (see our Device Master File guide)
- Plant Master File (PMF): Facilities, equipment, and quality control measures (refer to our Plant Master File guide)
- Essential Principles Compliance Checklist
- Risk Management File (per ISO 14971 standards; learn more about Risk Management)
- Product test reports from government-approved labs
- Labels and Instructions for Use (IFU)
- Quality Management System (QMS) documentation, typically ISO 13485:2016 certification
Import License Process (MD15) for Infant Resuscitation Tables
If you are an importer, the MD15 import license is mandatory and is issued by the Central Licensing Authority. The process includes:
- Preparation of documents including manufacturing license, Free Sale Certificate, ISO 13485:2016, CE Certificate, DMF, PMF, and wholesale license.
- Application submission using Form MD14 via the CDSCO MD Online Portal.
- Query resolution and final license issuance on Form MD15.
Import licenses generally take 5-6 months for completion.
Import License Documents Required
- Valid manufacturing license of the foreign manufacturer
- Free Sale Certificate from the country of origin
- ISO 13485:2016 certification
- CE Certificate (if applicable)
- Device Master File and Plant Master File
- Wholesale drug license for the importer
- Company constitution and address proof
Timeline and Processing Duration
| Process Step | Approximate Duration |
|---|---|
| Test License (MD13) | 1.5 – 2 months |
| Product Testing | 1 – 1.5 months |
| Document Preparation | 2 – 3 weeks |
| MD5 License Application & Audit | 1.5 – 2 months |
| Query Resolution & License Grant | 3 – 4 weeks |
Total estimated time: Approximately 3 to 4 months for manufacturing license.
Government Fees and Costs
- MD5 License Application Fee: ₹5,000 per application
- Product Fee: ₹500 per product
Additional costs include fees for notified body audits, product testing, and preparation of technical documentation.
Common Challenges and Practical Solutions
Delayed Testing Reports: Partner only with government-approved and reputed laboratories to avoid delays. Plan testing schedules well in advance.
Incomplete Documentation: Use comprehensive checklists and expert review to ensure all files like DMF, PMF, and Risk Management are thorough and compliant.
Audit Non-Compliance: Conduct pre-audit internal assessments to identify and rectify gaps in manufacturing and quality systems.
Query Handling: Respond promptly and clearly to CDSCO queries, providing supporting documents and clarifications without delay.
Expert Consultation and Support
With over 25 years of experience and having assisted 500+ companies, we specialize in streamlining the CDSCO licensing process for infant resuscitation tables and similar Class B devices. Our services include:
- End-to-end license application management
- Document preparation and review
- Coordination with notified bodies and testing labs
- Pre-audit readiness assessments
- Regulatory strategy and compliance consulting
Getting Started with Your CDSCO License Application
Assess your device classification: Confirm your infant resuscitation table is Class B per Medical Device Classification.
Prepare your documentation: Begin compiling your Device Master File and Plant Master File following industry best practices.
Apply for test license (MD13): Submit your application via the CDSCO MD Online Portal.
Schedule product testing: Engage with accredited government labs early to align testing timelines.
Plan for notified body audit: Select a notified body from the official list of notified bodies and schedule your audit.
Submit manufacturing license application (MD3) and follow through: Monitor application status regularly and address any queries swiftly.
Embarking on the CDSCO licensing pathway for infant resuscitation tables can seem complex, but with meticulous preparation and expert guidance, manufacturers and importers can achieve timely compliance and successful market entry. Contact us today to leverage our regulatory expertise and ensure your infant resuscitation tables meet all CDSCO requirements efficiently.
