CDSCO Manufacturing License for Urinary stone retrieval basket

Introduction

The Central Drugs Standard Control Organization (CDSCO) is a central regulatory body working under the Ministry of Health & Family Welfare, Government of India. It is India's national authority responsible for enhancing public health by ensuring the quality, safety, efficacy, and performance of medical devices and drugs.

In the medical device industry, acquiring relevant manufacturing licenses is of paramount importance. It not only enables legal manufacturing operations but also guarantees adherence to set quality standards, thereby ensuring patient safety and device effectiveness.

This blog will delve into the world of Urinary Stone Retrieval Basket, a crucial device in the field of Nephrology and Renal Care. Curious about how to manufacture it, or are you wondering about the license fees? Keep reading to find out, or visit the CDSCO portal here to access their official website.

What is the Urinary Stone Retrieval Basket?
The Role of CDSCO in Medical Device Regulation
How to manufacture Urinary Stone Retrieval Basket
Fees for a manufacturing license for Urinary Stone Retrieval Basket
Why is a Manufacturing License Necessary for Urinary Stone Retrieval Basket
Steps to Obtain a CDSCO Manufacturing License for Urinary Stone Retrieval Basket
Frequently Asked Questions (FAQs)
Conclusion

What is the Urinary Stone Retrieval Basket?

The Urinary Stone Retrieval Basket is a specialized medical device used to remove urinary stones (renal calculi) from the body during an endoscopic procedure.

Having been widely adopted in the field of Nephrology and Renal Care, the Urinary Stone Retrieval Basket serves an essential purpose in minimally invasive surgical procedures. It plays a significant role in ensuring patient comfort, reducing recovery periods, and significantly increasing the success rate in removing urinary stones.

The Role of CDSCO in Medical Device Regulation

The CDSCO was established with the mission to safeguard and enhance public health in India. Since its inception, CDSCO regulates the manufacture, sale, and distribution of drugs, ensuring they are safe and effective for their intended use.

CDSCO has a comprehensive regulatory framework for medical devices, thoroughly regulating their classification, licensing, device standards, clinical trials, manufacturing, sales and distribution, labeling, and product recall processes.

How to manufacture Urinary Stone Retrieval Basket

According to CDSCO standards, to manufacture a Urinary Stone Retrieval Basket, you must first acquire the necessary manufacturing license. For a class B risk urinary stone retrieval basket, an MD5 license is required.

Fees for a manufacturing license for Urinary Stone Retrieval Basket

For a Class B risk medical device such as the Urinary Stone Retrieval Basket, the relevant license is MD5. The fee for securing an MD5 license is Rs. 5,000, with an additional fee of Rs. 500 per product.

Why is a Manufacturing License Necessary for Urinary Stone Retrieval Basket

A manufacturing license is crucial for producing any medical device, including the Urinary Stone Retrieval Basket. It is:

Legally mandatory.
Essential for ensuring quality and safety in medical device productions.
Critical for maintaining regulatory compliance within the healthcare sector.
A measure to protect consumers and patients from substandard products.

Steps to Obtain a CDSCO Manufacturing License for Urinary Stone Retrieval Basket

Prepare the necessary documents such as the Device Master File, Quality Management Certificate, Device Details, Site details, etc.
The application process spans from submission to approval.
Overcome common challenges by understanding expected obstacles and preparing accordingly.

Detailed information about a Class B MD5 license can be found here.

Frequently Asked Questions (FAQs)

Q1: What is the risk class of Urinary Stone Retrieval Basket as per Medical Device Rules, 2017?

The Urinary Stone Retrieval Basket is classified as a Class B risk medical device.

Q2: What license is needed to manufacture Urinary Stone Retrieval Basket?

The required license for manufacturing Urinary Stone Retrieval Basket is MD5.

Q3: What is the fee for an MD5 license for Urinary Stone Retrieval Basket?

The fee for an MD5 license is Rs 5,000 for a license and Rs 500 per product.

Q4: Who will issue the manufacturing license for Urinary Stone Retrieval Basket?

The State FDAs are responsible for issuing licenses for Class B devices like the Urinary Stone Retrieval Basket.

Q5: Is repackaging of Urinary Stone Retrieval Basket considered manufacturing?

Yes, as per the Drugs and Cosmetics Act's definition of manufacturing, repackaging is considered manufacturing. Therefore, repackaging of the Urinary Stone Retrieval Basket also requires an MD5 license.

Conclusion

Understanding the CDSCO manufacturing license process for a medical device like the Urinary Stone Retrieval Basket can be understandably complex. However, expert assistance can make this journey smoother.

For consultation or assistance regarding the licensing process, do not hesitate to reach out to Pharmadocx Consultants, call us at +91-7404557227 or email us at [email protected]. We are here to help guide you through the journey to successful licensing, allowing you to focus on your mission of enhancing healthcare.