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CDSCO Manufacturing License for Gastric tonometry catheter

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Introduction

The Central Drugs Standard Control Organization (CDSCO) takes the helm in ensuring the safety, efficacy and quality of medical devices that are widely used in the healthcare industry in India. It is an Indian national regulatory authority that regulates the manufacture, import, distribution and sale of medical devices under the purview of Ministry of Health and Family Welfare, Government of India. In the ever-evolving medical device industry, it's of paramount importance to acquire manufacturing licenses for ethical operation and ensuring public safety.

In this blog, we delve into the intricacies of manufacturing a Gastric tonometry catheter, a gastroenterology medical device falling under the Category B risk class. This device plays a significant role in the medical realm, facilitating the critical diagnosis of mensenteric ischemia. You can know more about the CDSCO and its activities on their portal here.

What is a Gastric Tonometry Catheter?

A Gastric tonometry catheter is a sterile, medical-grade, flexible tube. It is designed explicitly for orogastric, nasogastric, or rectal insertion to sample carbon dioxide (CO2) from the mucosal vasculature of the stomach or sigmoid colon. The primary functionality of a Gastric tonometry catheter lies in its ability to measure the partial pressure (i.e., tonometry) of CO2 (pCO2), playing a crucial role in the diagnosis of mensenteric ischemia.

The Role of CDSCO in Medical Device Regulation

Established over a century ago, CDSCO has been diligently performing its mission to safeguard and enhance the public health in India. It oversees medical device regulations, ensuring their safety and efficacy. The medical devices are categorized into four risk classes A, B, C, and D - A being the lowest risk and D being the highest. The regulatory framework for these classes is streamlined that manufacturers abide by these regulations to maintain high quality standards.

How To Manufacture a Gastric Tonometry Catheter

To manufacture a Gastric tonometry catheter, a medical license is required as per the class stipulations by the CDSCO. The process of manufacturing involves stages of development, quality control, and regulation compliance.

Fees For Manufacturing License For Gastric Tonometry Catheter

As the Gastric tonometry catheter falls under Class B, the required medical license is MD5. The license fee for manufacturing this device is Rs. 5,000, with an additional Rs. 500 per product.

Why Is A Manufacturing License Necessary For Gastric Tonometry Catheter?

Acquiring a manufacturing license is a mandatory process for all manufacturers. It drives quality assurance, safety procedures and regulatory compliance in the production of medical devices. It safeguards consumers and patients against substandard or harmful devices, ensuring their well-being. It's within this framework that the Gastric tonometry catheter’s significance in healthcare shines, requiring a stringent production processes.

Steps To Obtain A CDSCO Manufacturing License For Gastric Tonometry Catheter

To obtain a CDSCO Manufacturing License, essential prerequisites and specific documentation are required, including Device Master File, Quality Management Certificate, Device Details, Site details, etc. Then comes the application process, which involves careful submission and anticipation for approval. There might be several common challenges faced during this process which can be overcome with proper planning and guidance.

Frequently Asked Questions (FAQs)

Q1: What is the risk class of Gastric Tonometry Catheter as per Medical Device Rules, 2017?

A: The Gastric Tonometry Catheter comes under risk class B as per Medical Device Rules, 2017.

Q2: What license is needed to manufacture Gastric Tonometry Catheter?

A: Manufacturing of Gastric Tonometry Catheter requires a MD5 license.

Q3: What is the fee for MD5 license for Gastric Tonometry Catheter?

A: The license fee for manufacturing Gastric Tonometry Catheter is Rs. 5000 for the license and Rs. 500 per product.

Q4: Who will issue the manufacturing license for Gastric Tonometry Catheter?

A: For Class B devices such as the Gastric Tonometry Catheter, the state FDA will issue the license.

**Q5: Is the repackaging of Gastric Tonometry Catheter considered manufacturing?

A: 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 Gastric Tonometry Catheter is also considered manufacturing requiring a license on MD5.

Conclusion

Navigating through the complex processes and technicalities of obtaining a manufacturing license for a Gastric tonometry catheter can be a daunting task. If you need assistance or have more queries regarding the licensing process, reach out to Pharmadocx Consultants. You can call us at "+91-7404557227" or send us an email at "[email protected]".

If you require an MD5 license for your medical device, visit our blog here for guidance. We are here to assist and empower businesses in the healthcare sector.

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