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CDSCO Manufacturing License for Flexible fibreoptic gastroduodenoscope

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Introduction

The Central Drugs Standard Control Organization (CDSCO) plays a quintessential role in India's healthcare system, largely by overseeing the quality of drugs and medical devices available in the Indian market. The medical device industry, a major part of the healthcare sector, relies heavily on licenses granted by the CDSCO for manufacturing various medical devices.

One such crucial medical device in the realm of gastroenterology is the Flexible fiberoptic gastroduodenoscope. This medical device serves as a crucial tool for examining and treating the upper gastrointestinal (GI) tract, ensuring steady health progression for patients with gastric complications. For more about CDSCO and its regulations, one can visit CDSCO's official portal here.

What is Flexible fibreoptic gastroduodenoscope?

A Flexible fiberoptic gastroduodenoscope, an innovative marvel in the medical device industry, is an endoscope with a flexible insertion portion. Its primary purpose is to visually examine and treat the upper gastrointestinal (GI) tract like the oesophagus, stomach, and duodenum (the first part of the small intestine), including the pancreas and the bile duct. This precision device is critical to gastroenterology, ensuring optimal patient health.

The Role of CDSCO in Medical Device Regulation

Since its inception, CDSCO has marked its presence with a crucial mission – to uphold the quality of drug and medical devices in India. The vision further extends to ensuring the safety and effectiveness of these products. In abiding by its mission, CDSCO forms a robust regulatory framework for regulating medical devices.

How to manufacture Flexible fibreoptic gastroduodenoscope

Creating a Flexible fibreoptic gastroduodenoscope involves complex precision and stringent regulatory compliance, ensuring its safe and effective use for the end customer. Manufacturing this medical device necessitates a manufacturing license from the CDSCO, which falls under risk class B—thus requiring an MD5 license.

Fees for manufacturing license for Flexible fibreoptic gastroduodenoscope

For the production of a Flexible fibreoptic gastroduodenoscope, an MD5 license is mandatory. The fee for the MD5 license is Rs. 5,000, and for each product, the charge is Rs. 500.

Why is a Manufacturing License Necessary for Flexible fibreoptic gastroduodenoscope?

Manufacturing licenses are crucial for medical devices to assure the quality and safety of the products. Compliance with regulations protects consumers and patients from substandard products, keeping their safety and health at the forefront. As such, producing a Flexible fibreoptic gastroduodenoscope demands a manufacturing license from the CDSCO.

Steps to Obtain a CDSCO Manufacturing License for Flexible fibreoptic gastroduodenoscope

  1. Gather necessary pre-requisites like Device Master File, Quality Management Certificate, Device Details, Site details, among others.
  2. Submit the application to the CDSCO.
  3. Await approval post submission.
  4. Tackle challenges that arise during the process, using insights and expert guidance.

With the application process streamlined, you can soon embark on your manufacturing journey with the right license in hand. Further information about obtaining an MD5 license can be found here.

Frequently Asked Questions (FAQs)

Q1. What is the risk class of Flexible fibreoptic gastroduodenoscope as per Medical Device Rules, 2017?

The risk class of Flexible fibreoptic gastroduodenoscope is class B.

Q2. What license is needed to manufacture Flexible fibreoptic gastroduodenoscope?

To manufacture Flexible fibreoptic gastroduodenoscope, an MD5 license is required.

Q3. What is the fee for the MD5 license for Flexible fibreoptic gastroduodenoscope?

The fee for the MD5 license is Rs. 5,000. Additionally, Rs. 500 is charged per product.

Q4. Who will issue the manufacturing license for Flexible fibreoptic gastroduodenoscope?

For class B medical devices like Flexible fibreoptic gastroduodenoscope, the state FDA will issue the license.

Q5. Is repackaging of Flexible fibreoptic gastroduodenoscope 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 a Flexible fibreoptic gastroduodenoscope is also considered manufacturing requiring an MD5 license.

Conclusion

Navigating the intricacies of the licensing process can be intimidating, but you don't have to do it alone. Pharmadocx Consultants are here to guide you through every step, ensuring you meet not only CDSCO's regulatory compliance but also excel in your medical device production endeavor. Feel free to reach out, call at +91-7404557227 or shoot an email at [email protected] for consultation or assistance.

With the right information, expert guidance, and compliance with regulatory norms, manufacturing Flexible fibreoptic gastroduodenoscope would be a clear vision.

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