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CDSCO Manufacturing License for Gastrostomy aspiration system stomach tube

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Introduction

The Central Drugs Standard Control Organization (CDSCO) is the central drug authority in India. It functions under the aegis of the Ministry of Health & Family Welfare, Government of India. Being India's national regulatory body for pharmaceuticals and medical devices, it plays an instrumental role in safeguarding and promoting public health by ensuring the quality, safety, and efficacy of drugs, cosmetics, and medical devices. CDSCO is responsible for approval of new drugs, conducting clinical trials, laying down the standards for drugs, control over the quality of imported drugs, coordination of the activities of State Drug Control Organizations and providing expert advice to bring about uniformity in the enforcement of the Drugs and Cosmetics Act.

The importance of manufacturing licenses in the medical device industry cannot be understated. The medical device industry is a highly regulated industry. The manufacturers of medical devices are required to meet stringent regulatory requirements and obtain licenses to ensure safety, quality, and efficacy of their devices. This is where a CDSCO License comes into play for Indian manufacturers.

In the next sections, we will discuss the Gastrostomy aspiration system stomach tube and its medical significance. For more details, you can visit CDSCO's portal here.

What is Gastrostomy aspiration system stomach tube?

The Gastrostomy aspiration system stomach tube can be described as a sterile, thin, flexible, hollow cylinder which is intended to be percutaneously implanted in the stomach of a morbidly obese (bariatric) patient. The tube aids in the removal of a portion of stomach contents after meals in conjunction with a dedicated gravity kit, constituting the external portion of a gastrostomy aspiration system.

This medical device has various applications such as facilitating weight loss, managing obesity and associated health conditions.

The Role of CDSCO in Medical Device Regulation

Since its inception, CDSCO has been driven by the mission to effectively regulate medical devices by implementing standards, conducting inspections, and providing licensing. Over the years, CDSCO has played a crucial role in the regulation of medical devices, ensuring that they meet the required safety and efficacy standards.

To achieve this, CDSCO has laid down a comprehensive regulatory framework for medical devices. This framework ensures that manufacturers meet stringent standards and adhere to best practices during the manufacturing process.

How to manufacture Gastrostomy aspiration system stomach tube

The manufacturing of a Gastrostomy aspiration system stomach tube involves several critical steps adhering to regulatory guidelines provided by CDSCO to ensure safety and efficacy.

Fees for manufacturing license for Gastrostomy aspiration system stomach tube

Given that the Gastrostomy aspiration system stomach tube falls under Class C of medical devices, it requires an MD9 license for manufacturing. The total fee for the MD9 license is Rs. 50,000, alongside Rs. 1,000 per product.

Why is a Manufacturing License Necessary for Gastrostomy aspiration system stomach tube?

Obtaining a manufacturing license is not optional but mandatory for the production of the Gastrostomy aspiration system stomach tube. This ensures that manufacturers follow established guidelines thereby ensuring the quality and safety of their product. Regulatory compliance is a key aspect of the healthcare sector, helping protect consumers and patients against substandard products.

Steps to Obtain a CDSCO Manufacturing License for Gastrostomy aspiration system stomach tube

The procedure for obtaining a CDSCO manufacturing license involves several stages. The manufacturer needs to submit the required documentation including Device Master File, Quality Management Certificate, Device Details, Site details among others.

The application process includes submission, review, and approval stages. Though the process may seem daunting, with the right knowledge and assistance, many of the common challenges can be overcome.

Frequently Asked Questions (FAQs)

Q1: What is the risk class of Gastrostomy aspiration system stomach tube as per Medical Device Rules, 2017? Answer: The risk class of Gastrostomy aspiration system stomach tube as per Medical Device Rules, 2017 is Class C.

Q2: What license is needed to manufacture Gastrostomy aspiration system stomach tube? Answer: The Gastrostomy aspiration system stomach tube requires an MD9 license for manufacturing.

Q3: What are the fees for the MD9 license for the manufacture of Gastrostomy aspiration system stomach tube? Answer: The fee for the MD9 license is Rs. 50,000 for the license and Rs. 1,000 per product.

Q4: Who will issue the manufacturing license for Gastrostomy aspiration system stomach tube? Answer: For class C medical devices such as the Gastrostomy aspiration system stomach tube, the CDSCO HQ in New Delhi will issue the manufacturing license.

Q5: Is repackaging of Gastrostomy aspiration system stomach tube considered manufacturing? Answer: Yes, as per the Drugs and Cosmetics Act's definition of manufacturing, repackaging of medical devices is considered manufacturing. Therefore, repackaging of Gastrostomy aspiration system stomach tube is also considered manufacturing requiring an MD9 license.

For more detailed information about the MD9 licensing process, you can refer to this article.

Conclusion

If you are a manufacturer requiring a CDSCO license for Gastrostomy aspiration system stomach tube or any other medical device, you may need professional assistance in understanding and dealing with the licensing process and overcoming the challenges. At Pharmadocx Consultants, we are ready to provide you comprehensive consultation and assistance. Please feel free to reach out to us on our website, call at +91-7404557227 or email at [email protected].

Remember, getting a manufacturing license for your medical device is not just a regulatory requirement, but also a step towards providing a safer and qualitative healthcare environment. Make sure you entrust the right consultants to ensure a smooth license obtaining process.

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