CDSCO License for Infant-hammock bed mattress

Comprehensive Guide to CDSCO Licensing for Infant-Hammock Bed Mattress (Class A Medical Device)

As seasoned regulatory consultants with over 25 years of experience supporting 500+ companies in India, we understand the critical importance of securing timely and compliant CDSCO licenses for innovative pediatric medical devices like the Infant-hammock bed mattress. This Class A device, designed with breathable netting to cradle infants safely during sleep, plays a vital role in reducing infant injuries and disorders such as SIDS and plagiocephaly. Navigating the CDSCO regulatory landscape efficiently ensures you can confidently bring this life-enhancing product to the Indian market.

CDSCO Regulatory Framework for Infant-Hammock Bed Mattress

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices under the Medical Device Rules (MDR) 2017, amended periodically. The Infant-hammock bed mattress falls under the Pediatrics and Neonatology category and is classified as a Class A (low-risk) device, per the official notification (File No. 29/MiscJ03/2020-DC (150), dated 23.8.2021).

Class A devices require licensing through state-level authorities, making the process more streamlined compared to higher-risk classes. Understanding this framework ensures you follow the right procedural steps for manufacturing or importing licensing.

Risk Classification and License Requirements

The Infant-hammock bed mattress is a Class A device, indicating low risk to patients. CDSCO mandates manufacturers of Class A devices to obtain the MD5 manufacturing license, issued by the State Licensing Authority. This license guarantees compliance with quality, safety, and performance standards.

Key highlights:

• License Type: MD5 (Manufacturing License for Class A & B devices)
• Governing Authority: State Licensing Authority
• Application Form: MD3
• Average Timeline: 3-4 months end-to-end
• Cost: ₹5,000 per application + ₹500 per product

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

Manufacturing License Process (MD5) for Infant-Hammock Bed Mattress

Obtaining the MD5 license involves several sequential steps:

1. Test License (Form MD13): Before manufacturing, apply for a Test License to allow trial production. This takes approximately 1.5-2 months.

2. Product Testing: Get the Infant-hammock mattress tested at government-approved laboratories to verify compliance with applicable standards. Refer to the List of Testing Laboratories.

3. Documentation Preparation: Assemble comprehensive technical and quality documents including Device Master File (DMF), Plant Master File (PMF), Risk Management File, and Essential Principles Checklist.

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

5. Audit by Notified Body: Undergo a mandatory audit by a notified body to assess manufacturing premises and QMS compliance. Check the Notified Bodies list for authorized entities.

6. Queries Resolution: Address any clarifications or deficiencies raised by CDSCO or the notified body.

7. Grant of License (Form MD5): Once all requirements are satisfactorily met, the MD5 license is issued.

For a stepwise walkthrough, our MD5 License Guide is an excellent resource.

Manufacturing License Documents Required

For Infant-hammock bed mattress manufacturing license application, prepare the following documents meticulously:

• Company Constitution (Incorporation Certificate, MOA/AOA)
• Proof of Ownership or Lease Agreement of Manufacturing Premises
• Details and Qualification Certificates of Technical Staff
• Fire No-Objection Certificate (NOC)
• Pollution Control Board NOC (if applicable)
• Device Master File (DMF) detailing design, materials, and manufacturing processes (Device Master File Guide)
• Plant Master File (PMF) outlining factory layout, equipment, and quality systems (Plant Master File Guide)
• Essential Principles Checklist confirming compliance with MDR requirements
• Risk Management File showcasing hazard analysis and mitigation (Risk Management Guide)
• Test Reports from accredited labs
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) Documents (e.g., ISO 13485:2016 certification if available)

Attention to detail in documentation significantly reduces processing time and audit queries.

Import License Process (MD15) - Relevant for Importers

If you intend to import the Infant-hammock bed mattress into India, you must obtain the MD15 import license issued by the Central Licensing Authority (CDSCO HQ). Key points include:

• Application on Form MD14 via the CDSCO MD Online Portal
• No test license required but product testing may be requested
• Review of documents such as Free Sale Certificate, ISO 13485, CE Certificate, Device & Plant Master Files
• Processing duration: 5-6 months
• Government fees vary by device risk class and number of products

For more, see our detailed Import License Guide.

Import License Documents Required

Importers must compile the following:

• Manufacturing License of the foreign manufacturer
• Free Sale Certificate or equivalent from country of origin
• ISO 13485:2016 or equivalent QMS certificate
• CE Marking Certificate (if applicable)
• Device Master File and Plant Master File
• Wholesale Drug License in India
• Company Constitution documents

Timeline and Processing Duration

Total Estimated Duration: Approximately 3 to 4 months from start to finish.

Planning well in advance and prompt submission of complete documents can favorably impact timelines.

Government Fees and Costs

For the Infant-hammock bed mattress (Class A):

• Test License Fee: ₹5,000
• Manufacturing License (MD5) Application Fee: ₹5,000
• Per Product Fee: ₹500
• Notified Body Audit Fees: Variable (typically ₹50,000 - ₹1,00,000 depending on scope)
• Testing Laboratory Charges: ₹20,000 - ₹50,000 depending on tests

Budgeting realistically for these expenses will avoid surprises.

Common Challenges and Solutions

• Incomplete Documentation: Double-check all files against the checklist. Use templates from our DMF and PMF guides.
• Delayed Testing Results: Engage accredited labs early and confirm turnaround times.
• Audit Non-Compliance: Conduct internal mock audits to identify gaps before notified body inspection.
• Queries from CDSCO: Respond promptly and comprehensively to avoid prolonged processing.

Our experience shows proactive communication with CDSCO and notified bodies greatly smoothens the licensing journey.

Expert Consultation and Support

With decades of regulatory expertise, we offer end-to-end assistance—from initial classification and documentation to audit readiness and final license grant. Our team ensures your Infant-hammock mattress meets all Indian regulatory norms swiftly and compliantly.

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm Class A status and licensing requirements.
2. Prepare Initial Documentation: Compile company and technical files, focusing on Device and Plant Master Files.
3. Apply for Test License (MD13): Submit online via the CDSCO MD Online Portal.
4. Schedule Product Testing: Book slots with notified testing labs early.
5. Develop Quality Management System: Align with ISO 13485 standards.
6. Plan for Notified Body Audit: Choose an appropriate notified body from the official list.

Taking these practical steps will set your Infant-hammock bed mattress manufacturing or import venture on a path to success in the Indian market.

For personalized guidance or to initiate your CDSCO license application, contact our expert regulatory team today.