CDSCO Manufacturing License for Laparoscopic cholangiography catheter/needle

Introduction

The Central Drugs Standard Control Organization (CDSCO) plays an integral role in instilling quality, safety, and efficacy in healthcare, ensuring that the medical devices available in the market match the international standards of quality and reliability. The extensive regulatory framework of CDSCO guides and oversees the process from the inception of manufacturing a medical device, estabilishing rules and regulations, and setting the standards, through their implementation and to the release of these products in the market.

In this light, the importance of CDSCO manufacturing licenses in the medical device industry cannot be understated. They serve as a proof of compliance with the stringent quality and safety measures set by CDSCO, certifying the medical device as fit for use.

In this article, we will look into one such device, the Laparoscopic Cholangiography Catheter/Needle, delving into its medical significance and its place within CDSCO's regulatory tapestry. Visit CDSCO's portal for deeper insights.

What is a Laparoscopic Cholangiography Catheter/Needle?

Laparoscopic Cholangiography Catheter/Needle is a sterile, flexible, single-lumen tube, equipped with a distal needle. Its intended use is to puncture the neck of the gallbladder (Hartmann’s pouch) during a laparoscopic cholangiography, a medical procedure that allows the injection of contrast media to visualize structures in the body.

Common uses of this device include gallstone diagnosis, removal surgeries, and other medical procedures involving visualization of the gallbladder or related structures.

The Role of CDSCO in Medical Device Regulation

The CDSCO's journey started with the objective to ensure that drugs and medical devices in India meet the required safety, efficacy and quality standards. Today, the CDSCO stands tall in its mission, setting and regulating the standards for drugs and medical devices, making its certification a hallmark of quality and safety.

When it comes to medical devices, factors such as risk class, category, and intended use, obtain their rightful importance under CDSCO's regulatory framework. A thorough understanding of these is necessary for the manufacturing license process.

How to Manufacture Laparoscopic Cholangiography Catheter/Needle

The manufacturing process involves specialized machines and techniques. In addition to the physical manufacturing process, compliance with CDSCO regulations is of paramount importance.

Fees for Manufacturing License for Laparoscopic Cholangiography Catheter/Needle

As it falls under risk class B, the license required for manufacturing Laparoscopic Cholangiography Catheter/Needle is MD5. The fees for MD5 is Rs. 5,000 for license and Rs. 500 per product.

Why is a Manufacturing License Necessary for Laparoscopic Cholangiography Catheter/Needle?

Obtaining a manufacturing license isn't just mandatory - it also serves several crucial purposes in the healthcare sector. First, it helps maintain quality assurance. The stringent guidelines by CDSCO ensure that every product that reaches the market is safe and efficacious.

A valid manufacturing license also helps protect consumers and patients from receiving substandard products. Compliance with the regulatory framework set in place by the CDSCO thus promotes patient safety.

Steps to Obtain a CDSCO Manufacturing License for Laparoscopic Cholangiography Catheter/Needle

The prerequisites for obtaining a manufacturing license include documentation like Device Master File, Quality Management Certificate, Device Details, Site details, etc.

The application process involves submission of these documents and ends with approval from CDSCO. Despite several challenges, with the right guidance, one can smoothly navigate through the process.

Frequently Asked Questions (FAQs)

Q. What is risk class of Laparoscopic Cholangiography Catheter/Needle as per Medical Device Rules, 2017? The risk class of Laparoscopic Cholangiography Catheter/Needle is B.

Q. What license is needed to manufacture Laparoscopic Cholangiography Catheter/Needle? The license needed to manufacture Laparoscopic Cholangiography Catheter/Needle is MD5.

Q. What is the fees for MD5 license for Laparoscopic Cholangiography Catheter/Needle? The fees for MD5 license is Rs. 5,000 for license and Rs. 500 per product.

Q. Who will issue the manufacturing license for Laparoscopic Cholangiography Catheter/Needle? For Class B devices, the state FDA will issue the license.

Q. Is repackaging of Laparoscopic Cholangiography Catheter/Needle considered manufacturing? Yes, as per the Drugs and Cosmetics Act's definition of manufacturing, repackaging is considered manufacturing. Likewise, the repackaging of Laparoscopic Cholangiography Catheter/Needle is also considered manufacturing, requiring an MD5 license.

Conclusion

The process to obtain a CDSCO Manufacturing license may seem daunting, but don't worry! Help is just a click away. Reach out for consultation or assistance regarding the licensing process to Pharmadocx Consultants or call +91-7404557227 or email to [email protected]. For more details on MD5, read our article here. We are here to make your journey to success smoother and easier!