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CDSCO License for Lamb feeding nipple.

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).

Device Class
Class A

Intended Use

A lamb feeding nipple is a device intended for use as a feeding nipple for infants with oral or facial abnormalities

Manufacturing License
MD5
Import License
MD15
CDSCO License for Lamb feeding nipple.

Introduction to Lamb Feeding Nipple and Its Regulatory Importance

A lamb feeding nipple is a specialized medical device designed for infants with oral or facial abnormalities to facilitate feeding. Classified under Class A (low risk) devices within the General Hospital or Orthopaedic Instruments category, it plays a critical role in neonatal care. Proper regulatory compliance through CDSCO licensing ensures both patient safety and market access in India, making it essential for manufacturers and importers to understand the regulatory landscape.

With over 25 years of experience and having assisted more than 500 companies in securing CDSCO licenses, we provide you with a comprehensive roadmap to navigate the licensing process specifically for lamb feeding nipples.

CDSCO Regulatory Framework for Lamb Feeding Nipples

The Central Drugs Standard Control Organization (CDSCO) governs the registration, manufacture, and import of medical devices in India under the Medical Device Rules, 2017. The lamb feeding nipple, notified under Notification No. 29/Misc./03/2020-DC (193)- Part-3 dated 16.03.2022, is classified as a Class A device, which is considered low risk.

Regulatory control for Class A devices is primarily managed by the State Licensing Authority, making the process more streamlined compared to higher-risk classes.

Risk Classification and License Requirements for Class A Devices

Class A devices like the lamb feeding nipple are categorized based on their intended use and minimal risk to patients. The license required for manufacturing is the MD5 License (Application Form MD3), issued by the State Authority.

For importers, the license required is MD15, granted by the Central Licensing Authority.

Understanding this classification is critical to selecting the correct application forms, documentation, and procedural steps.

Manufacturing License Process for Lamb Feeding Nipples (MD5 License)

The manufacturing license for Class A devices is granted by the State Licensing Authority and typically takes 3 to 4 months from start to finish. The process involves several key steps:

  1. Test License (Form MD13): Before applying for the manufacturing license, a test license valid for 12 months must be obtained. This step takes approximately 1.5 to 2 months.

  2. Product Testing: The device must be tested in CDSCO-approved government laboratories to ensure compliance with essential principles. You can find the list of approved testing laboratories here.

  3. Document Preparation: Complete all required documents, including Device Master File and Plant Master File.

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

  5. Audit by Notified Body: An audit of the manufacturing facility by a notified body is mandatory. Refer to the list of notified bodies for audit services.

  6. Query Resolution: Address any queries raised by the licensing authority or notified body.

  7. Grant of License (Form MD5): Upon satisfactory compliance, the license will be granted.

Manufacturing License Documents Required for Lamb Feeding Nipples

Preparing the correct documentation can be the difference between a smooth approval and delays. For lamb feeding nipples under Class A, you need:

  • Company Constitution documents (e.g., Incorporation Certificate, Partnership Deed)
  • Proof of ownership or lease agreement of manufacturing premises
  • Qualification and experience certificates of technical staff
  • Fire NOC and Pollution Control Board NOC
  • Device Master File (DMF) detailing design, specifications, and manufacturing process. Our detailed Device Master File guide can assist you.
  • Plant Master File (PMF) describing infrastructure and quality control systems. Learn how to create this with our Plant Master File guide.
  • Essential Principles Checklist confirming compliance with Indian regulations
  • Risk Management File demonstrating hazard analysis and mitigation. For practical steps, see our Risk Management resource.
  • Test Reports from government-approved labs
  • Labels and Instructions for Use (IFU)
  • Quality Management System (QMS) documents aligned with ISO 13485:2016

Import License Process for Lamb Feeding Nipples (MD15 License)

For companies intending to import lamb feeding nipples into India, an MD15 import license is mandatory and granted by the Central Licensing Authority. The process typically takes 5 to 6 months.

Steps include:

  1. Document Preparation: Compile all requisite documents including manufacturing license from the country of origin, Free Sale Certificate, ISO certification, CE certificate, and the device and plant master files.

  2. License Application (Form MD14): Submit through the CDSCO MD Online Portal with all supporting documents.

  3. Query Resolution: Address any clarifications requested by the authority.

  4. Grant of Import License (Form MD15): Upon satisfactory review, the license will be issued.

No test license is required for import applications.

Import License Documents Required for Lamb Feeding Nipples

Key documents include:

  • Valid Manufacturing License from the country of origin
  • Free Sale Certificate confirming the device is approved for sale
  • ISO 13485:2016 certification
  • CE Certificate (where applicable)
  • Device Master File and Plant Master File
  • Wholesale Drug License (if applicable)
  • Company Constitution documents

Government fees for import licenses vary by risk class and site count.

Timeline and Processing Duration

License TypeStepsApproximate Duration
Test License (MD13)Application, Testing, Issuance1.5 – 2 months
MD5 LicenseAudit, Query Resolution, Approval3 – 4 months total
MD15 Import LicenseDocument Review, Query Resolution5 – 6 months

Planning your submission with these timelines in mind helps prevent costly delays.

Government Fees and Costs

For a Class A device like the lamb feeding nipple:

  • MD5 Manufacturing License:

    • Application Fee: ₹5,000 per application
    • Per Product Fee: ₹500 per product
  • Test License (MD13): Fees vary by state but typically included in the overall application budget.

  • MD15 Import License:

    • ₹1,000 per site
    • ₹50 per product

Note that additional costs include laboratory testing, notified body audit fees, and consultancy charges, which should be budgeted accordingly.

Common Challenges and Solutions

Challenge: Delays in obtaining test reports from government-approved labs.

Solution: Initiate testing early and maintain regular communication with labs. Consider labs with quicker turnaround times listed on the CDSCO testing laboratories page.

Challenge: Incomplete or inconsistent documentation.

Solution: Use comprehensive checklists and templates for Device Master File and Plant Master File to ensure completeness. Our guides provide practical templates to avoid common pitfalls.

Challenge: Audit non-compliance findings.

Solution: Conduct internal pre-audits to identify gaps and implement corrective actions before the notified body visit.

Expert Consultation and Support

Navigating CDSCO regulations can be complex, especially for first-time applicants. We recommend engaging experienced regulatory consultants who can guide you through document preparation, audit readiness, and application submission. Our team has helped over 500 companies successfully obtain MD5, MD9, and MD15 licenses, ensuring a smoother, faster approval process.

Getting Started with Your CDSCO License Application for Lamb Feeding Nipples

To commence your licensing journey:

  1. Assess your device classification to confirm it falls under Class A.
  2. Prepare your test license application (Form MD13) and submit it via the CDSCO MD Online Portal.
  3. Schedule product testing with approved government laboratories.
  4. Compile your Device and Plant Master Files using our expert guides.
  5. Arrange for a notified body audit by selecting from the official notified bodies list.
  6. Submit your manufacturing license application (Form MD3) once testing and audit are complete.
  7. Respond promptly to authority queries to avoid delays.

By following these actionable steps and leveraging our 25+ years of regulatory expertise, you can confidently obtain your CDSCO license for lamb feeding nipples and successfully access the Indian market.

For detailed assistance, reach out to our regulatory experts and take the first step towards compliance today.

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About the Author

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Tails Azimuth
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