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CDSCO Manufacturing License for Transenteric drainage tube

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Introduction

The Central Drugs Standard Control Organization (CDSCO) is an esteemed institution responsible for the regulation and quality control of drugs and medical devices in India. This includes the formulation of policies, setting standards, and outlining protocols for the efficient conduct of research and development in addition to manufacturing and import/export of drugs and medical devices. One of the key roles of CDSCO includes issuing manufacturing licenses for medical devices, ensuring the production and availability of quality medical equipment in the healthcare sector.

The medical device under consideration for this article is the Transenteric Drainage Tube, an essential piece of equipment in the realm of gastroenterology. Its significance and constructive purpose will be elucidated in this post. For more primary information and related resources, consider visiting the CDSCO's portal here.

What is a Transenteric Drainage Tube?

A Transenteric Drainage Tube is a sterile, non-bioabsorbable tube intended to be endoscopically implanted for transmural drainage. Implicated mainly in gastroenterology, the tube is used for transmural drainage between the gastrointestinal (GI) tract and a pancreatic pseudocyst or the biliary tract. Endoscopic transmural drainage is a procedure used to drain cystic lesions that have formed a strong adhesion to the GI tract.

The Role of CDSCO in Medical Device Regulation

The CDSCO, with its mission for ensuring the availability, accessibility, and quality of drugs and medical devices in India, plays a critical role in the medical device regulation. It has a regulatory framework in place to establish protocols for medical device manufacturers. This framework ensures the quality, safety and efficacy of devices including our Transenteric Drainage Tube.

How to Manufacture a Transenteric Drainage Tube

By adhering to verified and accepted manufacturing protocols as directed by CDSCO and other international standards, a Transenteric Drainage Tube can be manufactured. The manufacturer needs to ensure that the process is suited to the design and material of the tube to maintain its sterility and functionality.

Fees for Manufacturing License for Transenteric Drainage Tube

Being a Class C medical device, the license required to manufacture a Transenteric Drainage Tube is the MD9 license. The licensure fee for MD9, as stipulated by the CDSCO is Rs. 50,000 and there is an additional fee of Rs. 1,000 per product.

Why is a Manufacturing License Necessary for Transenteric Drainage Tube?

Obtaining a manufacturing license for a medical device like the Transenteric Drainage Tube is crucial. It ensures the quality and safety of the product which is critical especially considering that it is used for patient care. Regulatory compliance is not only a legal necessity but also a moral obligation for manufacturers to prevent substandard products reaching out to patients.

Steps to Obtain a CDSCO Manufacturing License for Transenteric Drainage Tube

To obtain a manufacturing license, there are certain prerequisites that need to be fulfilled. Essential documents that must be submitted include the Device Master File, Quality Management Certificate, device and site details. After the submission of these, there is an application review phase until the final approval. Challenges encountered during this process can be overcome by meticulous preparation and understanding of all requirements. For detailed information, visit this article

Frequently Asked Questions (FAQs)

  • Q: What is the risk class of Transenteric Drainage Tube as per Medical Device Rules, 2017?
    A: The Transenteric Drainage Tube falls under Class C according to the Medical Device Rules, 2017.

  • Q: What license is needed to manufacture Transenteric Drainage Tube?
    A: The manufacture of a Transenteric Drainage Tube requires an MD9 license.

  • Q: What is fees for MD9 license for Transenteric Drainage Tube?
    A: The fee for an MD9 license which is required for Class C medical devices is Rs. 50,000 and there is an additional cost of Rs. 1000 per product.

  • Q: Who will issue manufacturing license for Transenteric Drainage Tube?
    A: For Class C medical device like Transenteric Drainage Tube, the CDSCO headquarters in New Delhi will issue the manufacturing license.

  • Q: Is repackaging of Transenteric Drainage Tube considered manufacturing?
    A: Yes, as per the Drugs and Cosmetics Act’s definition, repackaging of drugs is considered manufacturing and since medical devices are categorized as drugs, the repackaging of Transenteric Drainage Tube would also require a license; specifically, an MD9 license in this case.

Conclusion

The importance of obtaining a manufacturing license for medical devices is paramount. It ensures that the device is safe for use, and meets the necessarily stipulated quality standards. If you need further consultation or assistance regarding the licensing process, feel free to get in touch with Pharmadocx Consultants or call on +91-7404557227 or email at [email protected].

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