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CDSCO Manufacturing License for Flexible video gastroduodenoscope

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Introduction

The Central Drugs Standard Control Organisation or CDSCO is India's national regulatory body for pharmaceuticals and medical devices. Acquiring a manufacturing license is crucial for those involved in the production of medical devices. It ensures the quality and safety of products, adherence to the essential regulatory standards, and prevents the sale and distribution of substandard items that could pose health risks.

We are going to discuss one such important medical device, the Flexible Video Gastroduodenoscope, and its role in improving patient outcomes in gastroenterology. For further information on CDSCO, its regulatory guidelines, and application procedures, visit the official CDSCO portal here.

What is a Flexible Video Gastroduodenoscope?

A flexible video gastroduodenoscope is a medical device designed for visual examination and treatment of the upper gastrointestinal (GI) tract. This includes the oesophagus, stomach, duodenum, pancreas, and bile duct. The inserted portion of the gastroduodenoscope is flexible, aiding physicians in performing complex diagnostic procedures with increased precision and minimal discomfort to the patient.

The Role of CDSCO in Medical Device Regulation

Established with the objective to control and supervise the quality of drugs and medical devices in India, CDSCO plays a significant role in regulating the manufacturing, import, sale, and distribution of medical devices. The regulatory framework of CDSCO promotes the production of safe, effective, and qualitative medical devices.

How to manufacture a Flexible Video Gastroduodenoscope

The manufacturing process of a flexible video gastroduodenoscope involves precision engineering and strict quality checks. It is essential that the manufacturer adheres to the guidelines laid by CDSCO and follow the medical device manufacturing standards to ensure product safety and efficiency.

Fees for manufacturing license for a Flexible Video Gastroduodenoscope

As a Class B medical device, the license required to manufacture a Flexible Video Gastroduodenoscope is MD5. The fees for obtaining an MD5 license is Rs. 5,000, along with an additional Rs. 500 per product.

Why is a Manufacturing License Necessary for a Flexible Video Gastroduodenoscope?

Manufacturing licenses are mandatory to maintain the highest level of quality and safety in medical device production. It emphasizes the significance of regulatory compliance in the healthcare sector, ensuring patient safety, preventing health complications that could arise from utilizing substandard products.

Steps to Obtain a CDSCO Manufacturing License for a Flexible Video Gastroduodenoscope

Getting a manufacturing license from CDSCO involves the following steps:

  1. Submission of necessary documents that include the Device Master File, Quality Management Certificate, Device Details, Site details, among others.
  2. The application is thoroughly reviewed by the CDSCO.
  3. If compliant with CDSCO's standards, the license is issued.
  4. The manufacturer can then proceed with making the device.

Frequently Asked Questions (FAQs)

  1. Q: What is the risk class of a Flexible Video Gastroduodenoscope as per Medical Device Rules, 2017?
    A: The Flexible Video Gastroduodenoscope falls under Risk Class B as per Medical Device Rules, 2017.
  2. Q: What license is needed to manufacture a Flexible Video Gastroduodenoscope?
    A: The MD5 license is required to manufacture a Flexible Video Gastroduodenoscope.
  3. Q: What is the fee for MD5 license for a Flexible Video Gastroduodenoscope?
    A: The fee for an MD5 license is Rs. 5,000 and an additional Rs. 500 per product.
  4. Q: Who will issue the manufacturing license for a Flexible Video Gastroduodenoscope?
    A: For a Flexible Video Gastroduodenoscope, which is a Class B device, the state FDA issues the license.
  5. Q:Is repackaging of a Flexible Video Gastroduodenoscope considered manufacturing?
    A: Yes, as per the Drugs and Cosmetics Act's definition of manufacturing, repackaging of medical devices is also considered manufacturing. The Flexible Video Gastroduodenoscope requires an MD5 license for repackaging.

For a detailed explanation on obtaining an MD5 license, refer to this article - MD5 License

Conclusion

Understanding the regulations and guidelines for obtaining a manufacturing license can seem overwhelming. However, by collaborating with trustworthy consultants like Pharmadocx, you can make the licensing process smooth and hassle-free. For more information or assistance, visit Pharmadocx Consultants, or call at +91-7404557227, or send an email to [email protected].

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