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CDSCO Manufacturing License for Gastrostomy tube Y-piece connector

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Introduction

The Central Drugs Standard Control Organization (CDSCO) is India's national regulatory authority for pharmaceuticals and medical devices. As the central drug authority, CDSCO is responsible for approving new drugs, conducting pre-clinical and clinical trials, laying down the standards for drugs, control over the quality of imported drugs, and coordination of the activities of State Drug Control Organizations. In the medical device industry, manufacturing licenses play a crucial role in maintaining standards and safety.

This post focuses on the Gastrostomy tube Y-piece connector, a medical device that falls within risk class B. Its importance in healthcare is undeniable as it enables the administration of nutrient liquids and/or medication through a gastrostomy tube effortlessly, enhancing the care provided to patients with gastroenterology issues.

For more information about CDSCO or its processes, visit CDSCO's portal.

What is a Gastrostomy tube Y-piece connector?

This medical device is a sterile connecting device shaped in the form of a Y. It's designed for the connection to the proximal end of a gastrostomy tube, enabling the administration of nutrient liquids and/or medication. It’s a commonly used piece of equipment in gastroenterology procedures, supplementing patient feeding procedures and easing medicine administration.

The Role of CDSCO in Medical Device Regulation

CDSCO maintains a comprehensive framework for regulating medical devices in India. This includes setting guidelines, granting licenses, and overseeing production. CDSCO's regulatory framework manages the risk associated with the use of medical devices through a classification system where Class A signifies the lowest risk while class D represents the highest risk.

How to manufacture a Gastrostomy tube Y-piece connector

It's crucial to adhere to the regulatory framework while manufacturing any medical device, including the Gastrostomy tube Y-piece connector. Starting from design to sterilization, it requires expert knowledge, precision, and quality control to ensure that the product complies with all the necessary guidelines and standards for safety and efficacy.

Fees for manufacturing license for Gastrostomy tube Y-piece connector

As the Gastrostomy tube Y-piece connector falls within risk class B, the required license is MD5. MD5 license for manufacturing requires a payment of Rs. 5,000 with the license and an additional Rs. 500 per product. Further details and methods of payment are outlined in this PharmaDocx article.

Why is a Manufacturing License Necessary for a Gastrostomy tube Y-piece connector?

The manufacturing license is vital in assuring the quality and safety of the medical device production. Additionally, regulatory compliance in the healthcare sector protects consumers and patients from substandard products. It's mandatory for every manufacturer to obtain these licenses before initiating the manufacturing process.

Steps to Obtain a CDSCO Manufacturing License for a Gastrostomy tube Y-piece connector

The licensing process involves several steps and requires multiple documents such as Device Master File, Quality Management Certificate, Device Details, Site Details, etc. The process ranges from submission to approval and may present some challenges which can be overcome with expert guidance.

Frequently Asked Questions (FAQs)

Q1. What is the risk class of a Gastrostomy tube Y-piece connector as per Medical Device Rules, 2017?

The Gastrostomy tube Y-piece connector falls within Risk Class B.

Q2. What license is needed to manufacture a Gastrostomy tube Y-piece connector?

The required license to manufacture a Gastrostomy tube Y-piece connector is MD5.

Q3. What are the fees for the MD5 license for a Gastrostomy tube Y-piece connector?

The fees for the MD5 license include Rs. 5,000 for the license and Rs. 500 per product.

Q4. Who will issue the manufacturing license for a Gastrostomy tube Y-piece connector?

For Class A sterile and measuring & Class B devices, the state FDA will issue the license.

Q5. Is repackaging of a Gastrostomy tube Y-piece connector considered manufacturing?

Yes, as per the Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing. Medical devices, including a Gastrostomy tube Y-piece connector, are also classified as drugs. Hence, repackaging of this medical device is considered manufacturing requiring a license on MD5.

Conclusion

Venturing into the medical device manufacturing industry is not simple; it involves obtaining the right licenses, complying with regulations, and maintaining high production quality. If you have questions or need assistance in obtaining your manufacturing licenses, feel free to reach out to Pharmadocx Consultants or call "+91-7404557227" or email at [email protected]. Their expert team can help guide you through the process and ensure you meet all the necessary requirements.

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