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CDSCO Manufacturing License for Coma-arousal vagus nerve electrical stimulation system

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Introduction

The Central Drugs Standard Control Organization (CDSCO) forms the bedrock of India's healthcare and medical sector. Regulating not just the pharmaceutical domain, CDSCO offers a safety blanket in scrutinizing the introduction and circulation of medical devices used for different health conditions. The importance of manufacturing licenses in the medical device industry can hardly be overstated. It ensures that only those devices that meet the stringent quality standards set by CDSCO circulate in local markets, thereby safeguarding people's health.

One such medical device, critical to many patients' lives, is the Coma-arousal vagus nerve electrical stimulation system. This device holds significant medical importance, playing a crucial role in assisting patients suffering in a vegetative state and providing a possible way of regaining consciousness. Interested parties can find more information regarding the CDSCO regulations on its portal here.

What is Coma-arousal vagus nerve electrical stimulation system?

The Coma-arousal vagus nerve electrical stimulation system is a medical tool designed specifically to stimulate arousal from a deep coma or a vegetative state. This device applies periodic stimuli to the vagus nerve, an integral part of our brain responsible for consciousness. The purpose of these stimuli is to enable the patient to revive from their comatose state and thus improving their condition.

Common uses of this device are typically seen in severe neurological cases where the patient, due to significant brain damage, slips into a deep coma or a vegetative state. This tool plays an instrumental role in providing some chance of revival for these patients.

The Role of CDSCO in Medical Device Regulation

The Central Drugs Standard Control Organization (CDSCO) stands as the citadel of healthcare regulation in India. Over the years, CDSCO has continually strived to fortify, streamline, and regulate Indian healthcare, making it safer and ensuring that it meets international standards.

CDSCO's regulatory framework for medical devices is designed to ensure that all devices, including the Coma-arousal vagus nerve electrical stimulation system, meet rigorous safety and efficacy standards. This framework necessitates medical device manufacturers to attain manufacturing licenses, such as MD5 for Class B and MD9 for Class D devices, ensuring the upholding of stringent quality checks.

How to manufacture Coma-arousal vagus nerve electrical stimulation system

The manufacturing of Coma-arousal vagus nerve electrical stimulation system involves a methodical and stringent manufacturing process, adhering to the high-quality standards and guidelines laid down by CDSCO. It mandates obtaining a manufacturing license, in this case, an MD9 license, owing to the device's Class D risk classification.

Fees for manufacturing license for Coma-arousal vagus nerve electrical stimulation system

Given that the Coma-arousal vagus nerve electrical stimulation system is a Class D medical device, it requires an MD9 license for manufacturing. The fees for acquiring this license is Rs. 50,000, plus an additional Rs.1,000 per product.

Why is a Manufacturing License Necessary for Coma-arousal Vagus Nerve Electrical Stimulation System?

The necessity of a manufacturing license for Coma-arousal vagus nerve electrical stimulation system stems from the imperative need to ensure quality, safety, and efficacy of the device, given its high-risk nature. Regulatory compliance in the healthcare sector is paramount for consumer protection from substandard products. It helps in documenting the quality and performance of the device, safeguarding patients' interests.

Steps to Obtain a CDSCO Manufacturing License for Coma-arousal vagus nerve electrical stimulation system

The process of obtaining a CDSCO manufacturing license involves the following steps:

  1. Satisfying the pre-requisites like Device Master File, Quality Management Certificate, Device Details, Site details etc.
  2. Submitting the application for the license through the online portal.
  3. Awaiting approval, usually communicated through email.
  4. Addressing any issues or queries raised during the review process.

Frequently Asked Questions (FAQs)

Q. What is the risk class of Coma-arousal vagus nerve electrical stimulation system as per Medical Device Rules, 2017?
A. It is classified as Risk Class D, the highest risk category, as per the Medical Device Rules, 2017.

Q. What license is needed to manufacture Coma-arousal vagus nerve electrical stimulation system?
A. An MD9 license is required to manufacture Coma-arousal vagus nerve electrical stimulation system.

Q. What is the fee for an MD9 license for a Coma-arousal vagus nerve electrical stimulation system?
A. The fee for obtaining an MD9 license is Rs. 50,000 for the license and Rs.1,000 per product.

Q. Who will issue the manufacturing license for Coma-arousal vagus nerve electrical stimulation system?
A. The CDSCO HQ in New Delhi will issue the license for manufacturing such this device.

Q. Is repackaging of Coma-arousal vagus nerve electrical stimulation system considered manufacturing?
A. 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. Medical Device Rules have been made under the provisions of Drug Act only, and hence repackaging of Coma-arousal vagus nerve electrical stimulation system is also considered manufacturing requiring an MD9 license.

Conclusion

It is clear that getting a CDSCO Manufacturing License for a medical device such as the Coma-arousal vagus nerve electrical stimulation system involves several crucial steps, each having its significance. It is recommended to seek expert consultation or assistance regarding the licensing process to ensure a seamless and hassle-free experience. We encourage you to reach out to us at Pharmadocx Consultants for any help or queries regarding the licensing process. Feel free to navigate our site here, give us a call directly via "+91-7404557227", or email us at "[email protected]". Remember, we are always ready to help you!

For further information on the MD9 licensing process, make sure to read our detailed article here.

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