Published on

CDSCO Manufacturing License for Pancreatic stent

Authors
  • avatar
    Name
    CDSCO Licenses Blog
    Twitter

Introduction

CDSCO (Central Drugs Standard Control Organization) is India's central regulatory body for pharmaceuticals and medical devices. Its key function is to ensure that the drugs and medical devices available to the public meet the necessary standards of safety, efficacy, and quality. The making, selling, and distribution of medical devices require a license issued by this organization, a step that signifies the device's quality and safety. One such significant device is the Pancreatic stent, a key tool in gastroenterology. CDSCO has a user-friendly portal to facilitate seamless interactions between the manufacturers and the regulatory body. Visit CDSCO's portal for more information.

What is the Pancreatic Stent?

A pancreatic stent is a small tube made of plastic or metal that is inserted into the pancreatic duct to keep it open. It is commonly used in procedures involving the pancreas, especially in patients suffering from chronic pancreatitis and other pancreatic conditions.

The Role of CDSCO in Medical Device Regulation

Historically, CDSCO has played a pivotal role in healthcare regulation in India. Its mission to safeguard and enhance public health by assuring safety, efficacy, and quality of drugs, cosmetics, and medical devices is unwavering. It has a comprehensive regulatory framework for medical devices, in which the quality and safety of these devices are ensured through rigorous testing and approval processes.

How to Manufacture Pancreatic Stent

This section is retained for later updates.

Fees for Manufacturing License for Pancreatic Stent

As a Class C device, to manufacture a Pancreatic stent a MD9 license is required. The fee for MD9 is Rs. 50,000 for license and Rs. 1,000 per product. For more details please visit MD9 License details

Why is a Manufacturing License Necessary for Pancreatic Stent?

Acquiring a manufacturing license is not only a mandatory requirement but it's also a reflection of commitment to quality and safety in medical device production. This adherence to regulatory compliance plays a major role in the healthcare sector. Without such regulations, consumers and patients can be exposed to substandard and potentially harmful products.

Steps to Obtain a CDSCO Manufacturing License for Pancreatic Stent

This includes certain Pre-requisites and documentations like Device Master File, Quality Management Certificate, Device Details, Site details, etc. Further, the application process involves submission to approval projected in a four-step succinct path to be followed for efficiency. Challenges are expected, but they can be resolved with the right resources and guidance.

Frequently Asked Questions (FAQs)

  1. What is the risk class of Pancreatic Stent as per Medical Device Rules, 2017? The pancreatic stent falls under risk Class C.

  2. What license is needed to manufacture Pancreatic Stent? To manufacture Pancreatic Stent, a MD9 license is needed.

  3. What are the fees for MD9 license for Pancreatic Stent? The fees for MD9 license is Rs. 50,000 for the license and Rs. 1,000 per product.

  4. Who will issue the manufacturing license for Pancreatic Stent? The CDSCO HQ in New Delhi will issue the manufacturing license for Pancreatic Stent.

  5. Is repackaging of Pancreatic Stent considered manufacturing? Yes, as per Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing and by further definitions, medical devices are also drugs. Medical Device Rules have been made under the provisions of Drug Act only and hence repackaging of Pancreatic Stent is also considered manufacturing requiring a license on MD9.

Conclusion

Obtaining a CDSCO Manufacturing License can seem like a daunting process. It's a path riddled with numerous procedures, documentation, and regulatory hurdles. However, you're not alone in this journey; experts at Pharmadocx Consultants are always ready to assist. Reach out for consultation or assistance regarding the licensing process at "Pharmadocx Consultants" or give us a call at "+91-7404557227"or you can also drop us an email at "[email protected]". We're here to ensure your path to obtaining your CDSCO manufacturing license is smooth and hassle-free.

Note: This blog post is written considering SEO best practices and incorporates considerable use of keywords relating to CDSCO and medical devices.

cdsco import license in india banner
cdsco manufacturing license in india banner