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CDSCO Manufacturing License for Gastrointestinal endoscopic clip, long-term

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Introduction

Welcome to this comprehensive guide on the intricacies of obtaining a CDSCO Manufacturing License for Gastrointestinal Endoscopic Clip, Long-term. The Central Drugs Standard Control Organization (CDSCO) is India's National Regulatory Authority (NRA), which is entrusted with the responsibility of ensuring the quality and safety of medical devices manufactured in India. As we delve into the details of manufacturing licenses, it's essential to understand their significant role in the medical device industry.

The manufacturing license is a vital document that signifies a manufacturer's permission to produce a specific type of medical device, such as the Gastrointestinal Endoscopic Clip, Long-term. This specialized and highly useful medical device has a prominent place in the field of Gastroenterology. You can learn more about the CDSCO and its functions from their official portal here.

What is Gastrointestinal Endoscopic Clip, Long-term?

A Gastrointestinal Endoscopic Clip, long-term, is a sterile medical device that's designed to stay implanted within the gastrointestinal tract for more than 30 days. Its main functions include endoscopic marking, haemostasis, tissue approximation, closure of luminal perforations, and treating mucosal/submucosal defects during an endoscopic procedure.

This medical device finds common use in gastroenterology, where it plays a crucial part in the detection, prevention and treatment of various gastrointestinal conditions.

The Role of CDSCO in Medical Device Regulation

The CDSCO, under the Ministry of Health and Family Welfare, is primarily entrusted with establishing standards and regulatory measures for drugs, cosmetics, and medical devices alike. Its mission is to safeguard and enhance public health by assuring the safety, efficacy, and quality of these products.

The CDSCO has a well-defined regulatory framework for medical devices, classified into four risk categories - A, B, C, and D, each requiring specific types of manufacturing licenses.

How to Manufacture a Gastrointestinal Endoscopic Clip, Long-term

Manufacturing a Gastrointestinal Endoscopic Clip, long-term, involves a thorough process that must comply with the standards and recommendations set out by the CDSCO.

Fees for Manufacturing License for a Gastrointestinal Endoscopic Clip, Long-term

As per the CDSCO, a Risk Class C medical device like a Gastrointestinal Endoscopic Clip, long-term, requires an MD9 license. The fees for MD9 are Rs. 50,000 for license and Rs. 1,000 per product. You can learn more about the MD9 license here.

Why is a Manufacturing License Necessary for Gastrointestinal Endoscopic Clip, Long-term

Securing a manufacturing license is a necessary condition to fulfill before producing any medical device in India. This enforces quality and safety in medical device production, promoting regulatory compliance in the healthcare sector, and protecting consumers and patients from substandard products.

Steps to Obtain a CDSCO Manufacturing License for Gastrointestinal Endoscopic Clip, Long-term

To secure a CDSCO Manufacturing License, you would need to:

  1. Gather necessary documents like Device Master File, Quality Management Certificate, Device Details, Site details, etc.
  2. Submit the application
  3. Await the approval process
  4. Overcome any potential challenges in the process

Frequently Asked Questions (FAQs)

Q1. What is the risk class of Gastrointestinal Endoscopic Clip, Long-term as per Medical Device Rules, 2017?

The risk class of Gastrointestinal Endoscopic Clip, Long-term, is Class C.

Q2. What license is needed to manufacture Gastrointestinal Endoscopic Clip, Long-term?

An MD9 license is needed to manufacture Gastrointestinal Endoscopic Clip, Long-term.

Q3. What are the fees for an MD9 license for Gastrointestinal Endoscopic Clip, Long-term?

The fees for MD9 are Rs. 50,000 for license and Rs. 1,000 per product.

Q4. Who will issue manufacturing license for Gastrointestinal Endoscopic Clip, Long-term?

For Class C devices like Gastrointestinal Endoscopic Clip, Long-term, CDSCO HQ in New Delhi will issue the license.

Q5. Is repackaging of Gastrointestinal Endoscopic Clip, Long-term considered manufacturing?

Yes, as per the Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs and by extension medical devices, is considered manufacturing. Thus, repackaging of Gastrointestinal Endoscopic Clip, Long-term is also considered manufacturing and requires an MD9 license.

Conclusion

We hope that this guide has provided some clarity on the process of obtaining a manufacturing license for a Gastrointestinal Endoscopic Clip, Long-term. If you need further consultation or assistance regarding the licensing process, the experts at Pharmadocx Consultants would be more than happy to help. You can reach them at +91-7404557227 or via email at [email protected].

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