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CDSCO Manufacturing License for Gastro-oesophageal pH/impedance catheter, non-sterile

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Introduction

The Central Drugs Standard Control Organization (CDSCO) is India's paramount pharmaceutical and medical device regulatory authority that ensures the safety, efficacy, and quality of drugs and medical devices in the country. Manufacturing licenses are integral to the medical device industry, permitting businesses to produce, sell, and distribute high-quality medical devices legally. Today, we will delve into the CDSCO's manufacturing license for the Gastro-oesophageal pH/impedance catheter, non-sterile, a vital device in gastroenterology. Its importance lies in its usage in diagnosing gastro-oesophageal reflux disease (GERD), gastric ulcers, and other gastrointestinal conditions. Log onto CDSCO's portal for more information.

What is a Gastro-oesophageal pH/impedance catheter, non-sterile?

A Gastro-oesophageal pH/impedance catheter is a non-sterile, flexible tube equipped with electronic sensors at its end. It's designed to be inserted through the nose into the oesophagus and stomach. The device measures pH and electrical impedance, essential indicators in evaluating gastrointestinal conditions like GERD and gastric ulcers.

The Role of CDSCO in Medical Device Regulation

Established under the Drugs and Cosmetics Act, 1940, CDSCO has been championing the cause of safeguarding public health in India for decades. CDSCO regulates the standards and quality of medical devices through a well-defined regulatory framework, ensuring safe and effective medical devices are available to citizens.

How to manufacture a Gastro-oesophageal pH/impedance catheter, non-sterile

The processes involved in the manufacturing of any medical device are impacted by a host of factors such as the type of device, materials used, production methods, and quality control measures. As a Class B risk device, the manufacturing process of a Gastro-oesophageal pH/impedance catheter, non-sterile, needs to adhere to specific guidelines and protocols to maintain the safety and reliability of the device.

Fees for manufacturing license for a Gastro-oesophageal pH/impedance catheter, non-sterile

A manufacturing license for a Class B medical device such as a Gastro-oesophageal pH/impedance catheter, non-sterile, requires an MD5 license. The fees for an MD5 license are Rs. 5000 for the license and an additional Rs. 500 per product.

Why is a Manufacturing License Necessary for a Gastro-oesophageal pH/impedance catheter, non-sterile?

Securing a manufacturing license ensures adherence to strict standards of quality and safety—a crucial requirement in the dynamic medical device production landscape. Moreover, regulatory compliance in the healthcare sector is a critical component and helps protect consumers from substandard products.

Steps to Obtain a CDSCO Manufacturing License for a Gastro-oesophageal pH/impedance catheter, non-sterile

To obtain a manufacturing license, the following steps should be taken:

  1. Ensure all pre-requisites are complete and necessary documents, including the Device Master File, Quality Management Certificate, Device Details, Site details, etc., are in place.
  2. Complete the application process, which involves submission and obtaining approval.
  3. Be aware of common challenges and understand how to overcome them.

Frequently Asked Questions (FAQs)

Q: What is the risk class of a Gastro-oesophageal pH/impedance catheter, non-sterile as per Medical Device Rules, 2017?

A: As per the Medical Device Rules, 2017, a Gastro-oesophageal pH/impedance catheter, non-sterile is categorised as a Class B risk device.

Q: What license is needed to manufacture a Gastro-oesophageal pH/impedance catheter, non-sterile?

A: The manufacture of a Gastro-oesophageal pH/impedance catheter, non-sterile requires an MD5 license.

Q: What is the fee for an MD5 license for a Gastro-oesophageal pH/impedance catheter, non-sterile?

A: The fees for an MD5 license are Rs. 5,000 for the license and an additional Rs. 500 per product.

Q: Who will issue the manufacturing license for a Gastro-oesophageal pH/impedance catheter, non-sterile?

A: For the Class B device, the state FDA will issue the license.

Q: Is repackaging of a Gastro-oesophageal pH/impedance catheter, non-sterile considered manufacturing?

A: Yes, repackaging of a Gastro-oesophageal pH/impedance catheter, non-sterile is considered manufacturing. As such, it requires an MD5 license.

Conclusion

Navigating the complex terrain of CDSCO medical device regulation and licensing can be challenging. However, with sound knowledge and valuable consultation, you can steer your way through the complexities of regulatory compliance. For assistance regarding all aspects of the licensing process or any queries, don't hesitate to reach out to Pharmadocx Consultants. Feel free to call on "+91-7404557227" or send an email to "[email protected]" for further assistance.

For detailed license procedure, please follow this link.

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