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CDSCO Manufacturing License for Flexible ultrasound gastroduodenoscope

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Introduction

The Central Drugs Standard Control Organization (CDSCO) is a paramount regulatory organization in India. It governs the quality and safety of drugs, cosmetics, diagnostics, and medical devices, ensuring the health and well-being of consumers and patients. In the medical devices sector, manufacturing licenses are obligatory, ensuring the products' quality standards and safety.

Our focus today is on one such critical medical device, the Flexible Ultrasound Gastroduodenoscope. This gastroenterology device aids in the visual examination and treatment of the upper gastrointestinal (GI) tract, playing a vital role in diagnosing and treating several medical conditions. Instant information regarding CDSCO licenses and related details can be found on the CDSCO portal here.

What is Flexible Ultrasound Gastroduodenoscope?

A Flexible Ultrasound Gastroduodenoscope is a medical device that combines the functionality of an endoscope with an ultrasound probe. The key purpose of this instrument is to facilitate a non-invasive visualization of the upper gastrointestinal tract - including oesophagus, stomach, duodenum, pancreas, and the bile duct - with the help of ultrasound imaging.

This gastroenterology device is commonly used for diagnostic and therapeutic purposes, particularly in identifying and treating conditions related to the upper GI tract.

The Role of CDSCO in Medical Device Regulation

CDSCO has been instrumental in laying down standards and regulatory measures for the assurance of quality for drugs, cosmetics, diagnostics, and medical devices in India.

The regulatory body formulates a framework that classifies medical devices into four risk classes - A, B, C, D. The Flexible Ultrasound Gastroduodenoscope falls under Class B. Each class governs a different level of risk, where Class A signifies the lowest risk devices, and Class D refers to the highest risk devices.

How to manufacture Flexible Ultrasound Gastroduodenoscope

Manufacturing a Flexible Ultrasound Gastroduodenoscope involves stringent adherence to quality and safety standards. The manufacturing process involves various steps under different controlled environments to preserve the device's quality and safety.

Fees for manufacturing license for Flexible Ultrasound Gastroduodenoscope

Given Gastroduodenoscope's categorization in risk Class B, the necessary CDSCO license for manufacturing is the MD5 license. The MD5 licence's fee stands at Rs. 5,000 for the license and an additional Rs. 500 per product.

Why is a Manufacturing License Necessary for Flexible Ultrasound Gastroduodenoscope?

Obtaining a manufacturing license is mandatory for producing Flexible Ultrasound Gastroduodenoscope. This regulatory control ensures the quality and safety of these medical devices before their distribution and use. Patient safety and welfare are of paramount importance, and devices such as Gastroduodenoscope have direct impact on healthcare and treatment outcome.

Regulatory compliance in the healthcare sector protects consumers and patients from substandard and potentially harmful products. It is crucial for the manufacturers to understand and comply with the licensing requirements to ensure that their product is safe and effective.

Steps to Obtain a CDSCO Manufacturing License for Flexible Ultrasound Gastroduodenoscope

Gaining a manufacturing license involves meticulous documentation and a clear understanding of the regulations.

  1. Prepare Device Master File, Quality Management Certificate, Device Details, Site details, and other relevant documentation.
  2. Submit the application with appropriate details.
  3. Await approval after the verification and assessment process.
  4. Once the license is granted, commence manufacturing adhering to the specified guidelines.

You can access comprehensive consultation for the MD5 licensing process here

Frequently Asked Questions (FAQs)

1. Q. What is the risk class of the Flexible Ultrasound Gastroduodenoscope as per Medical Device Rules, 2017?

  • A. The Flexible Ultrasound Gastroduodenoscope is categorized under risk Class B.

2. Q. What license is needed to manufacture the Flexible Ultrasound Gastroduodenoscope?

  • A. The necessary license for manufacturing a Class B device like the Gastroduodenoscope is the MD5 license.

3. Q. What is the fee for the MD5 license for the Flexible Ultrasound Gastroduodenoscope?

  • A. The fee for the MD5 license is Rs. 5,000 for the license and Rs. 500 per product.

4. Q. Who will issue the manufacturing license for the Flexible Ultrasound Gastroduodenoscope?

  • A. For Class B devices like the Gastroduodenoscope, the state FDA (Central Drugs Standard Control Organization) will issue the manufacturing license.

5. Q. Is repackaging of Flexible Ultrasound Gastroduodenoscope considered manufacturing?

  • A. Yes, as per the Drugs and Cosmetics Act's definition of manufacturing, the repackaging of drugs, and by extension, medical devices, is considered manufacturing. Thus, repackaging of Flexible Ultrasound Gastroduodenoscope requires a license, in this case, the MD5.

Conclusion

Regulations in the healthcare sector are critical, serving to ensure the efficacy, safety, and quality of medical devices and drugs - protecting consumers from substandard products. Obtaining a manufacturing license from CDSCO involves multiple stages, including extensive documentation and compliance checks.

If you need guidance or consultation in this process, reach out to Pharmadocx Consultants. You can visit their website here, call directly on +91-7404557227, or email at [email protected]. They offer expert guidance to smooth your journey towards regulatory compliance, ensuring your products meet all necessary standards and requirements.

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