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CDSCO Manufacturing License for Nasogastric tube holder, intranasal

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Introduction

The Central Drugs Standard Control Organization (CDSCO) is India's primary pharmaceutical and medical device regulator. This national regulatory body, supervised by the Ministry of Health & Family Welfare, operates to ensure the quality, safety, efficacy, and availability of health products in India.

Among its many responsibilities, the CDSCO regulates the manufacturing, import, conduct of clinical trials, laying down standards, sale, and distribution of medical devices under the provisions of the Drugs and Cosmetics Act, 1940, and Medical Device Rules, 2017. Having manufacturing licenses in the medical device industry plays an integral role in ensuring that the manufacturers meet the expected standards of safety and quality.

In this context, let's delve into the nuances of getting a manufacturing license for a medical device of significant medical importance – the Nasogastric Tube Holder, Intranasal. This device is an integral part of gastroenterology, being widely used to secure a nasogastric tube and prevent displacement or removal.

Interested readers can visit CDSCO's portal here.

What is Nasogastric Tube Holder, Intranasal?

The Nasogastric Tube Holder, Intranasal, is a non-sterile, non-surgically invasive device. Its role is to secure a nasogastric tube, which is inserted through the nose and goes down the esophagus into the stomach, to the nose of a patient. This application prevents any displacement or removal of the tube, ensuring the tube stays in place for smoother administration of nutritive substances or medicine.

This device finds extended use in hospitals, nursing homes, and sometimes, even domestic settings. It's a go-to, easy-use tool for securing nasogastric tubes in patients who require this facility for a prolonged period.

The Role of CDSCO in Medical Device Regulation

The creation of CDSCO traces back to the Drugs & Cosmetics Act of 1940 and the Rules thereunder, 1945. Since then, the organization has been channeling its efforts towards meeting international standards of drugs and medical devices quality control. It functions under the Director General of Health Services in the Ministry of Health and Family Welfare.

CDSCO's pivotal role in Medical Device Regulation includes eradicating subpar medical and pharmaceutical products by setting and enforcing regulations, granting licenses for manufacturing and imports, surveillance of marketed products, and more. It monitors medical device manufacturers for compliance with regulations. For Nasogastric Tube Holder, Intranasal—an integral medical device classified under Class B risk—the CDSCO has laid down specific guidelines relating to its manufacture and distribution.

How to Manufacture Nasogastric Tube Holder, Intranasal

For manufacturing this device, a license is required under the tag MD5. Firms desiring to venture into their production need to comply with the regulatory framework set by CDSCO, follow strict manufacturing practices, meet the stringent quality parameters, and more.

Fees for Manufacturing License for Nasogastric Tube Holder, Intranasal

To obtain the necessary MD5 license, there is a fee of Rs. 5,000 for the license, plus Rs. 500 per product. More details about the process and the fees can be found on this link.

Why is a Manufacturing License Necessary for Nasogastric Tube Holder, Intranasal?

Acquiring a manufacturing license from a trusted national regulatory body like CDSCO is a prerequisite for any medical device manufacturer. Firstly, the mandatory nature of this license stems from the need to uphold the safety, efficacy, and quality of these devices.

The license signifies the manufacturer's commitment to meet the set standards, thus ensuring patients are not exposed to substandard products. Furthermore, it symbolizes the manufacturer's adherence to regulatory compliance—an aspect that holds immense significance in the healthcare sector.

Steps to Obtain a CDSCO Manufacturing License for Nasogastric Tube Holder, Intranasal

  1. Pre-requisites and documentation required: A list of documents such as Device Master File, Quality Management Certificate, Device Details, Site details are required for application.
  2. The application process: The process involves submission of required documents and fees, followed by a review by CDSCO. Upon approval, the license is issued.
  3. Understanding of potential challenges and measures to overcome them: Consultation and assistance are essential for smooth navigation through the process.

Frequently Asked Questions (FAQs)

Q1. What is the risk class of the Nasogastric Tube Holder, Intranasal, as per Medical Device Rules, 2017?

  • Class B

Q2. What license is needed to manufacture Nasogastric Tube Holder, Intranasal?

  • MD5

Q3. What is the fee for an MD5 license for Nasogastric Tube Holder, Intranasal?

  • Rs. 5,000 for license, plus Rs. 500 per product

Q4. Who will issue the manufacturing license for Nasogastric Tube Holder, Intranasal?

  • For Class B devices, the state FDA will issue the license.

Q5. Is repackaging of Nasogastric Tube Holder, Intranasal considered manufacturing?

  • Yes, as per Drugs and Cosmetics Act's definition of manufacturing, repackaging of medical devices is considered manufacturing. Hence, repackaging of Nasogastric Tube Holder, Intranasal, requires a license of MD5.

Conclusion

The licensing process to manufacture medical devices in India, while rigorous, is necessary for the betterment of the healthcare sector at large. If you're considering entering the medical device industry and need guidance on obtaining your CDSCO manufacturing license for Nasogastric Tube Holder, Intranasal, reach out to Pharmadocx Consultants for expert assistance. You can also call us directly at "+91-7404557227" or email us at "[email protected]".

Remember, your commitment to the highest standards of quality and safety can bridge the gap between life and health. Let's work together towards a healthier future.

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