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

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Introduction

The medical industry is heavily regulated to ensure that the products and services that reach the end consumer maintain the highest levels of safety, efficacy, and quality. India is no different. The Central Drugs Standard Control Organization (CDSCO) is the national regulatory body for pharmaceuticals, and medical devices in India. In particular, the CDSCO oversees the licensing of medical device manufacturing.

One such regulated product is the Gastro-oesophageal pH/impedance catheter. This device is crucial to the evaluation and treatment of certain gastrointestinal conditions, such as GERD and gastric ulcers. This blog provides an understanding of the licensing process for manufacturing this device. For more detailed information, refer to the official CDSCO portal here.

What is Gastro-oesophageal pH/impedance catheter?

The Gastro-oesophageal pH/impedance catheter is a sterile flexible tube with an electrical conductor at its distal end. This device is typically inserted through the nose into the oesophagus and stomach for measuring pH and/or electrical impedance. These measurements assist in the evaluation of conditions like gastro-oesophageal reflux disease (GERD), gastric ulcers, and other gastrointestinal problems. This valuable tool is used frequently in procedures related to gastroenterology and aids doctors in accurate diagnosis and treatment planning.

The Role of CDSCO in Medical Device Regulation

The CDSCO, plays a critical role in the Indian healthcare ecosystem. Its primary mission is to safeguard and enhance public health by assuring the safety, efficacy and quality of drugs, cosmetics and medical devices. It is involved in the approval of new drugs and formulations, conducting clinical trials, laying down the standards for drugs, and regulating the market authorization of medical devices, among other responsibilities.

When it comes to medical devices, CDSCO has established a regulatory framework that categorizes devices into four classes - A, B, C and D based on the associated risks; Class A being the lowest risk and D being the highest. Each class needs a different license for manufacturing, Class A sterile and measuring devices and Class B devices require an MD5 license, and Class C and D devices require an MD9 license.

How to manufacture Gastro-oesophageal pH/impedance catheter

The manufacturing of a Gastro-oesophageal pH/impedance catheter, a Class B medical device, requires attention to its specific clinical function and the corresponding regulations. The process must comply with standards for product design, material selection, sterile production environment, quality control, and product labelling. The manufacturer must also prepare comprehensive technical documentation regarding the nature of the device, its intended use, and information on the risk management system in place.

Fees for manufacturing license for Gastro-oesophageal pH/impedance catheter

As the Gastro-oesophageal pH/impedance catheter falls under the Class B category, the necessary license required is MD5. The fee for an MD5 license is Rs. 5,000, and an additional product-specific fee of Rs. 500 is charged. For a detailed breakdown of the costs, one can refer to this article.

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

It is mandatory to acquire a manufacturing license to ensure the quality and safety of the medical device production process. Compliance with regulatory guidelines protects the healthcare sector from substandard products, mitigates risk, and enforces control over the market. Additionally, legally authorized products guarantee a greater sense of security and trust among patients and healthcare practitioners.

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

  1. Prepare the necessary documents like Device Master File, Quality Management Certificate, Device Details, Site details, etc.
  2. Submit the necessary documents for licensing.
  3. Wait for the review and approval from the licensing authority.
  4. Resolve any queries or discrepancies that arise during the application review.

Overcoming challenges in the licensing process usually involves obtaining professional advice, maintaining due diligence and quality assurance.

Frequently Asked Questions (FAQs)

Q1. What is the risk class of Gastro-oesophageal pH/impedance catheter as per Medical Device Rules, 2017?

  • The risk class for Gastro-oesophageal pH/impedance catheter as per Medical Device Rules, 2017 is 'B'.

Q2. What license is needed to manufacture Gastro-oesophageal pH/impedance catheter?

  • The required license to manufacture a Gastro-oesophageal pH/impedance catheter, a Class B medical device, is an MD5 license.

Q3. What is the fees for MD5 license for Gastro-oesophageal pH/impedance catheter?

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

Q4. Who will issue the manufacturing license for Gastro-oesophageal pH/impedance catheter?

  • For manufacturing Class B medical devices such as the Gastro-oesophageal pH/impedance catheter, the state FDA will issue the license.

Q5. Is repackaging of Gastro-oesophageal pH/impedance catheter considered manufacturing?

  • Yes, as per Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing. In the case of medical devices which are also classified as drugs, repackaging would require a license on MD5.

Conclusion

The process of obtaining a CDSCO Manufacturing License for medical devices can be a complex one. It is crucial to navigate this process correctly to ensure regulatory compliance and product safety. If you have any doubts, require consultation, or assistance for the licensing process, please feel free to reach out to Pharmadocx Consultants. Visit our website here, or call us on +91-7404557227, or mail us your queries at [email protected].

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