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CDSCO Manufacturing License for Diagnostic somatosensory tactile stimulation system

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Introduction

The Central Drugs Standard Control Organization (CDSCO) plays a pivotal role in public health protection by ensuring the quality, safety, and efficacy of medical devices in India. In the dynamic and ever-evolving medical device industry, possessing the necessary manufacturing licenses is crucial. Today, we delve into the Diagnostic somatosensory tactile stimulation system - an invaluable tool in the neurological domain. We'll dive deep into its role, its CDSCO classification, manufacturing license requirements, and more. Please refer to CDSCO's portal here for more detailed information.

What is a Diagnostic Somatosensory Tactile Stimulation System?

The Diagnostic somatosensory tactile stimulation system is a medical device primarily used to apply tactile stimuli to the human body. This is generally done through pneumatic activation applied to highly sensitive body parts, like the fingers and lips - primarily for evoked response procedures that investigate the functions and potential issues in the brain.

The Role of CDSCO in Medical Device Regulation

The Central Drugs Standard Control Organization (CDSCO) is India's premier national regulatory body for medical devices, responsible for approving licenses for the manufacture, sale and distribution of medical devices. Specifically, the CDSCO dictates regulatory frameworks, based on risk classes, for the manufacture of medical devices including the Diagnostic somatosensory tactile stimulation system.

How to Manufacture a Diagnostic Somatosensory Tactile Stimulation System

For Class B devices, like the Diagnostic somatosensory tactile stimulation system, the necessary license for manufacturing is MD5, as per CDSCO guidelines.

Fees for Manufacturing License for Diagnostic Somatosensory Tactile Stimulation System

The fees for an MD5 license is Rs 5,000 for the license and an additional Rs 500 per product.

Why is a Manufacturing License Necessary for a Diagnostic Somatosensory Tactile Stimulation System?

Gaining a manufacturing license is a mandatory process as it maintains safety and quality standards in medical device production. Having a license ensures that the manufacturer has followed regulatory compliance, safeguarding consumers and patients against substandard products.

Steps to Obtain a CDSCO Manufacturing License for Diagnostic Somatosensory Tactile Stimulation System

Here are the requisites to obtain a manufacturing license -

  • Submission of necessary documents like the Device Master File, Quality Management Certificate, Device Details, Site details, etc.
  • Following the application process from submission to approval.
  • Overcoming common challenges that may arise during the process.

For more details on how to get an MD5 License for class A and B devices like the Diagnostic somatosensory tactile stimulation system, please refer to this article

Frequently Asked Questions (FAQs)

  • Q.1 What is the risk class of Diagnostic somatosensory tactile stimulation system as per Medical Device Rules, 2017?

    The Diagnostic somatosensory tactile stimulation system falls under Class B as per the Medical Device Rules, 2017.

  • Q.2 What license is needed to manufacture Diagnostic somatosensory tactile stimulation system?

    An MD5 license is required for the manufacture of Diagnostic somatosensory tactile stimulation system.

  • Q.3 What is the fees for MD5 license for Diagnostic somatosensory tactile stimulation system?

    The fees for an MD5 license is Rs 5,000 for the license and an additional Rs 500 per product.

  • Q.4 Who will issue the manufacturing license for Diagnostic somatosensory tactile stimulation system?

    For Class B devices like the Diagnostic somatosensory tactile stimulation system, the state FDA will issue the MD5 license.

  • Q.5 Is repackaging of Diagnostic somatosensory tactile stimulation system considered manufacturing?

    Yes, as per Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing and by further definitions, medical devices are also drugs. Hence repackaging of Diagnostic somatosensory tactile stimulation system is considered manufacturing requiring a license on MD5.

Conclusion

Navigating the intricate process of obtaining manufacturing licenses may pose certain challenges. Don't hesitate to seek help. To ease this process, consider reaching out to the Pharmadocx Consultants. You can visit their website, call them directly at +91-7404557227, or send an email to [email protected]. They provide professional consultation and assistance regarding the licensing process, thus ensuring smooth sailing.

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