CDSCO Manufacturing License for Non-vascular catheter introduction set

Introduction

The Central Drugs Standard Control Organization (CDSCO), India's national regulatory agency for drugs and medical devices, plays a crucial role in ensuring the quality, safety, and efficacy of these products. A vital part of this process involves issuing licenses for the manufacturing of various medical devices. These licenses are critical in maintaining the standard and reliability of medical devices produced in India.

In this article, we will discuss a particular medical device – the Non-vascular catheter introduction set, a Class B Medical Device used primarily in Gastroenterology. We will also delve into the various aspects of obtaining a manufacturing license for this device from the CDSCO.

CDSCO’s official portal can be accessed here for further details.

• What is a Non-vascular catheter introduction set?
• The Role of CDSCO in Medical Device Regulation
• How to manufacture a Non-vascular catheter introduction set
• Fees for manufacturing license for a Non-vascular catheter introduction set
• Why is a Manufacturing License Necessary for a Non-vascular catheter introduction set?
• Steps to Obtain a CDSCO Manufacturing License for a Non-vascular catheter introduction set
• Frequently Asked Questions (FAQs)
• Conclusion

What is a Non-vascular catheter introduction set?

A Non-vascular catheter introduction set is a set of sterile, invasive devices designed for the percutaneous Seldinger-type introduction of a non-vascular catheter into a body cavity or lumen (for instance, the biliary tract or ureter). This device is primarily used in the field of Gastroenterology.

The Role of CDSCO in Medical Device Regulation

The CDSCO, is responsible for ensuring the safety, quality, and efficacy of drugs and medical devices in India. Over the years, CDSCO has played an integral part in the evolving healthcare sector by setting up robust regulatory frameworks for medical devices.

How to manufacture a Non-vascular catheter introduction set

To manufacture a Non-vascular catheter introduction set, a manufacturer must obtain the necessary licenses from the CDSCO. For a Class B device like the Non-vascular catheter introduction set, an MD5 license is required.

Fees for manufacturing license for a Non-vascular catheter introduction set

The licensing fee for a Class B device is Rs. 5000 for the MD5 license. Each product requires an additional processing fee of Rs. 500.

Why is a Manufacturing License Necessary for a Non-vascular catheter introduction set?

Obtaining a manufacturing license is mandatory. It ensures product quality and safety. A manufacturing license signifies regulatory compliance – an essential aspect of the healthcare sector. It also plays a crucial role in protecting patients and consumers from substandard products.

Steps to Obtain a CDSCO Manufacturing License for a Non-vascular catheter introduction set

1. Prepare the necessary documents, including the Device Master File, Quality Management Certificate, Device Details, and Site details.
2. Submit the application.
3. Wait for the approval process.
4. Overcome any common challenges that arise.

For more detailed information about the MD5 license process, refer to this article.

Frequently Asked Questions (FAQs)

1. Q. What is the risk class of a Non-vascular catheter introduction set as per Medical Device Rules, 2017?

   A. The Non-vascular catheter introduction set is classified as a Class B device.

2. Q. What license is needed to manufacture a Non-vascular catheter introduction set?

   A. An MD5 license is required to manufacture a Non-vascular catheter introduction set.

3. Q. What is the fee for an MD5 license for a Non-vascular catheter introduction set?

   A. The fee for an MD5 license is Rs. 5000, plus an additional Rs. 500 per product.

4. Q. Who will issue the manufacturing license for a Non-vascular catheter introduction set?

   A. The state FDA will issue the license for Class A sterile and measuring & Class B devices.

5. Q. Is repackaging of a Non-vascular catheter introduction set considered manufacturing?

   A. Yes, repackaging of a Non-vascular catheter introduction set is considered manufacturing, requiring an MD5 license.

Conclusion

Navigating the process for obtaining a manufacturing license can be a challenging endeavor. That’s why we at Pharmadocx Consultants are here to help. We assist in the application process, helping you understand and meet all regulatory requirements. You can reach out to us for consultation or assistance regarding the licensing process at Pharmadocx Consultants. Call us at +91-7404557227, or email us at [email protected], or visit our website here. We look forward to supporting you in your journey towards regulatory compliance in the healthcare sector.