CDSCO License for Infant care table

Comprehensive Guide to CDSCO Licensing for Infant Care Tables (Class A Medical Devices)

As a trusted regulatory consultancy with over 25 years of experience and having successfully guided 500+ companies through the CDSCO licensing maze, we understand the critical importance of compliance and timely approvals for medical devices. Infant care tables, classified as Class A devices under the CDSCO framework, are essential pediatric products designed to provide a safe and hygienic environment for newborn care activities such as washing and changing nappies. This article provides an in-depth, practical roadmap to securing the necessary CDSCO manufacturing license (MD5) for infant care tables, helping manufacturers and importers navigate the regulatory landscape efficiently.

CDSCO Regulatory Framework for Infant Care Tables

Infant care tables fall under the pediatric and neonatology category and are regulated as Class A medical devices by the Central Drugs Standard Control Organization (CDSCO). As a Class A device, the regulatory pathway is overseen primarily by the State Licensing Authority and involves a simplified, yet thorough, compliance process aligned with the Medical Devices Rules, 2017.

The regulatory framework ensures that these devices meet safety, quality, and performance standards to protect vulnerable newborns. The notification governing infant care tables is documented under File No. 29/MiscJ03/2020-DC (150) dated 23.08.2021.

Risk Classification and License Requirements for Infant Care Tables

Under CDSCO’s risk classification:

• Class A devices are low-risk devices, including infant care tables.
• License required: MD5 Manufacturing License (Application Form MD3), issued by the State Licensing Authority.

Manufacturers must obtain a test license (MD13) before applying for the manufacturing license, ensuring product testing and compliance verification.

For a detailed understanding of device classification, visit our Medical Device Classification guide.

Manufacturing License Process for Infant Care Tables (MD5 License)

The manufacturing license process for infant care tables involves the following sequential steps:

1. Apply for Test License (Form MD13): This prerequisite license allows you to conduct mandatory product testing in government-recognized laboratories.

2. Product Testing: Testing must be completed in CDSCO-approved labs. A list of such labs is available on the CDSCO Testing Laboratories page.

3. Documentation Preparation: Compile and prepare the required documents, including Device Master File and Plant Master File.

4. License Application (Form MD3): Submit the MD5 manufacturing license application through the CDSCO MD Online Portal.

5. Audit by Notified Body: An audit is conducted by an approved notified body to verify compliance with quality and safety standards. Refer to the Notified Bodies List.

6. Response to Queries: Address any queries or deficiencies raised by CDSCO or the notified body promptly.

7. Grant of License: Upon satisfactory compliance, the State Licensing Authority issues the MD5 license.

For an in-depth stepwise guide, see our MD5 License Guide.

Manufacturing License Documents Required for Infant Care Tables

Successful application requires submission of comprehensive documentation. Key documents include:

• Company Constitution Proof: Incorporation certificate, partnership deed, or trust deed.
• Proof of Premises Ownership or Lease Agreement: Valid documents proving legal occupancy.
• Technical Staff Credentials: Qualification certificates and experience proof of technical personnel.
• Fire No Objection Certificate (NOC): From local fire department.
• Pollution Control Board NOC: Environmental clearance as applicable.
• Device Master File (DMF): Detailed product specifications, manufacturing process, and quality controls. Our Device Master File guide offers practical insights.
• Plant Master File (PMF): Details of manufacturing facility, infrastructure, and quality systems. See our Plant Master File guide for assistance.
• Essential Principles Checklist: Compliance checklist in line with the Medical Device Rules.
• Risk Management File: Documented risk assessment and mitigation strategies. Learn more about Risk Management.
• Test Reports: Laboratory test certificates evidencing conformity.
• Labels and Instructions for Use (IFU): Product labeling and user manuals.
• Quality Management System (QMS) Documents: ISO 13485 certification and internal SOPs.

Ensuring completeness and accuracy of these documents is crucial to avoid delays.

Import License Process for Infant Care Tables (MD15 License)

For importers intending to bring infant care tables into India, an MD15 import license issued by the Central Licensing Authority is mandatory. The process includes:

• Preparation of required documents including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485 certification, CE Certificate, Device and Plant Master Files, wholesale license, and company constitution.
• Application submission on the CDSCO MD Online Portal.
• Query resolution and document verification by CDSCO.
• License grant typically within 5-6 months.

Refer to our detailed Import License Guide for comprehensive support.

Import License Documents Required

Key documents include:

• Manufacturing license from the country of origin.
• Free Sale Certificate.
• ISO 13485:2016 certification.
• CE Certificate.
• Device Master File.
• Plant Master File.
• Wholesale License.
• Company Constitution documents.

Fees vary based on device class and number of products.

Timeline and Processing Duration for Infant Care Table Licensing

For MD5 Manufacturing License (Class A devices):

• Test License (MD13): Approximately 1.5 to 2 months.
• Product Testing: 3-4 weeks depending on lab capacity.
• Audit and Application Processing: 1.5 to 2 months.

Total estimated time: 3 to 4 months from test license application to final license grant.

For MD15 Import License: Typically takes 5 to 6 months.

Government Fees and Costs

For manufacturing infant care tables (Class A devices) via MD5 license:

• Application fee: Rs. 5,000 per application.
• Per product fee: Rs. 500 per product.

Additional costs include testing fees at government-approved labs and audit fees payable to notified bodies.

Budgeting for these costs upfront helps prevent surprises during the process.

Common Challenges and Practical Solutions

Challenge 1: Delays in Product Testing

Testing backlogs at government laboratories often cause delays.

Solution: Engage with multiple CDSCO-approved testing labs early and schedule tests promptly. Utilize the Testing Laboratories list to select a lab with availability.

Challenge 2: Incomplete Documentation

Incomplete or inaccurate documents lead to repeated queries and delays.

Solution: Adhere strictly to document checklists. Utilize expert guides like our Device Master File guide and Plant Master File guide to prepare robust submissions.

Challenge 3: Audit Non-compliance

Failing audits due to quality system gaps or infrastructure issues.

Solution: Conduct internal audits before notified body visits and implement corrective actions. Maintain updated QMS documents and ensure facility readiness.

Expert Consultation and Support

Navigating the CDSCO regulatory process for infant care tables can be complex, especially for first-time applicants. Our extensive experience supporting over 500 companies means we provide:

• Customized regulatory strategy aligned with your product and business model.
• Comprehensive document preparation and review services.
• Coordination with testing labs, notified bodies, and CDSCO officials.
• Training and support for audit readiness and QMS implementation.

Partnering with seasoned consultants reduces risk, accelerates approval timelines, and ensures regulatory compliance.

Getting Started with Your CDSCO License Application for Infant Care Tables

1. Assess Device Classification: Confirm your infant care table falls under Class A.
2. Register on the CDSCO MD Online Portal: Create your account here.
3. Prepare Test License Application (Form MD13): Gather basic company and product information.
4. Select Testing Laboratory: Choose from CDSCO-approved labs to submit samples.
5. Compile Required Documentation: Use our guides for Device and Plant Master Files.
6. Submit Test License Application: Await approval to begin testing.
7. Complete Product Testing: Obtain test reports.
8. Prepare Manufacturing License Application (Form MD3): Organize all compliance documents.
9. Engage Notified Body for Audit: Schedule and prepare for audit.
10. Submit Application and Follow Up: Monitor application status and respond to queries promptly.

Starting early and maintaining clear communication with all stakeholders will smooth your path to licensing success.

For personalized assistance or to discuss your infant care table's regulatory strategy, please contact our expert team.

By following this comprehensive guide, manufacturers and importers can confidently approach the CDSCO licensing process for infant care tables, ensuring timely market entry and regulatory compliance in India.