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CDSCO Manufacturing License for Gastrostomy aspiration system gravity set

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Introduction

The Central Drugs Standard Control Organization (CDSCO) plays a pivotal role in protecting and promoting public health in India. The organization's immense responsibilities include regulating drug safety, approval of new drugs, and oversight of clinical trials. Equally crucial is its regulatory control over medical devices in the healthcare sector.

Manufacturing licenses are a vital element in the medical device industry. They ensure that the medical devices produced adhere to the required quality standards and are safe for use. This is where CDSCO steps in with its scientifically designed risk classification, mandatory to obtain a manufacturing license.

One such medical device that has been profoundly impacting the lives of bariatric patients is the Gastrostomy aspiration system gravity set. This article will shed light on the significance of this medical device, the role of CDSCO in regulating its manufacturing and license process, and the necessary steps to obtain the license. In-depth knowledge about the required license, the fees, and the necessity for this license will also be detailed.

To know more about CDSCO and its regulations, please visit this link.

What is Gastrostomy aspiration system gravity set?

The Gastrostomy aspiration system gravity set is a collection of non-sterile devices. It is designed as the external part of a gastrostomy aspiration system. This medical device is aimed for use by post-surgical patients, precisely those who have undergone the implantation of the stomach tube.

The sole purpose of the system is to remove a specific portion of stomach contents post meals, through aspiration. This is particularly significant in the case of morbidly obese (bariatric) patients who are aged 18 or above. The aspiration system helps to achieve portion control, subsequently aiding weight loss in these patients.

The Role of CDSCO in Medical Device Regulation

Throughout its existence, CDSCO's mission has been to continually raise the standard of quality and safety of drugs and medical devices in India. It specializes in the regulatory framework for medical devices, ensuring they adhere to the top-notch quality and safety standards.

The regulatory framework, put forth by CDSCO, divides medical devices into different risk classes- A, B, C, and D. The objective of this stratification is to make the licensing process more defined and unambiguous.

How to manufacture Gastrostomy aspiration system gravity set

The manufacturing process of the Gastrostomy aspiration system gravity set should abide by the guidelines laid by the CDSCO. In the case of a Class C medical device like the Gastrostomy aspiration system gravity set, the required license is MD9.

Fees for manufacturing license for Gastrostomy aspiration system gravity set

The fees for the MD9 license is Rs. 50,000 for the license and Rs. 1,000 per product.

Why is a Manufacturing License Necessary for Gastrostomy aspiration system gravity set?

Obtaining a manufacturing license is mandatory for the Gastrostomy aspiration system gravity set. This is not just a formality but ensures quality and safety in the production of the medical device. This regulatory compliance is of immense significance in the healthcare sector.

Furthermore, it protects consumers and patients from substandard products, ensuring that they receive medical devices of the highest quality.

Steps to Obtain a CDSCO Manufacturing License for Gastrostomy aspiration system gravity set

The process of obtaining a CDSCO Manufacturing License is a stepwise procedure. The necessary prerequisites include the Device Master File, Quality Management Certificate, Device Details, and Site details. Upon the acquisition of these documents, the application process commences, from submission to approval. Certain challenges might arise during the process, yet they can be overcome with the right guidance.

Frequently Asked Questions (FAQs)

Q. What is the risk class of Gastrostomy aspiration system gravity set as per Medical Device Rules, 2017?

The Gastrostomy aspiration system is classified under risk class C category.

Q. What license is needed to manufacture Gastrostomy aspiration system gravity set?

The MD9 license is required to manufacture the Gastrostomy aspiration system gravity set.

Q. What is the fee for an MD9 license for the Gastrostomy aspiration system gravity set?

The fees for the MD9 license are Rs. 50,000 for the license and Rs. 1,000 per product.

Q. Who will issue the manufacturing license for the Gastrostomy aspiration system gravity set?

The manufacturing license for the Class C devices such as the Gastrostomy aspiration system gravity set is issued by CDSCO HQ in New Delhi.

Q. Is the repackaging of Gastrostomy aspiration system gravity set considered manufacturing?

Yes, as per the Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing. Medical devices are also considered drugs. Thus, repackaging the Gastrostomy aspiration system gravity set is considered manufacturing in the eyes of CDSCO regulations, requiring an MD9 license.

Conclusion

The process of obtaining a license for manufacturing a medical device can be an uphill task, filled with complex procedures and documentation. This is where our team of professionals at Pharmadocx Consultants comes into the picture. We offer comprehensive consultation and assistance regarding the licensing process.

Please feel free to visit "Pharmadocx Consultants" for further details. You can also call us at "+91-7404557227" or email us at "[email protected]" for a comprehensive discussion regarding the process. To read about the license process in detail, visit this link.

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