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CDSCO Manufacturing License for Gastrointestinal manometric catheter, electronic

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Introduction

The Central Drugs Standard Control Organization (CDSCO) is a central regulatory body in India under the Ministry of Health and Family Welfare which is responsible for ensuring the safety, efficacy, and quality of drugs and medical devices. In the medical device industry, manufacturing licenses are of utmost importance to verify that the production of medical devices complies with the set regulatory standards. This guarantees the delivery of safe, efficient, and high-quality devices to the healthcare sector.

In this blog post, we will focus on the Gastrointestinal manometric catheter, electronic, a critical medical device in the domain of Gastroenterology. We will discuss its manufacturing process, the licensing requirements, and related procedures, governed by CDSCO.

For more information, you can visit CDSCO's portal here.

What is Gastrointestinal manometric catheter, electronic?

A Gastrointestinal manometric catheter, electronic devises is specifically designed and used to evaluate peristaltic motility in the gastrointestinal (GI) tract. It is a non-sterile flexible tube with electronic sensors at its distal end, which can be inserted through the nose or rectum into the GI tract. The device measures pressure across the pharynx, oesophagus, stomach, duodenum, small bowel, colon, and anorectal area, thereby providing essential diagnostic information. It may additionally be intended to measure pH and electrical impedance and contain a lumen.

This device has significant uses and procedures in the field of Gastroenterology. It helps in diagnosing various disorders in the gastrointestinal tract, documenting motility abnormalities, and evaluating the effectiveness of the treatment provided.

The Role of CDSCO in Medical Device Regulation

CDSCO, since its establishment, has played a crucial role in ensuring the safety and effectiveness of drugs and medical devices through its rigorous regulatory framework. Over the years, it has formulated various rules and guidelines for the production, import, sales, and distribution of medical devices, including Gastrointestinal manometric catheter, electronic. CDSCO's regulatory framework for medical devices categorises them into risk classes A, B, C, and D, with A being the lowest risk and D being the highest risk. Our device comes under class B risk.

How to manufacture Gastrointestinal manometric catheter, electronic

The manufacturing process of Gastrointestinal manometric catheter, electronic demands meticulousness to ensure device effectiveness and patient safety. Appropriate licensing needs to be procured following CDSCO’s guidelines for class B medical devices. Manufacturing facilities must also ensure compliance with the Quality Management Certificate directives.

Fees for manufacturing license for Gastrointestinal manometric catheter, electronic

As Gastrointestinal manometric catheters, electronic fall under class B risk, the required license for its manufacturing is MD5. The fee for an MD5 license is Rs. 5,000, with additional fees of Rs. 500 per product. More about the MD5 license can be found here.

Why is a Manufacturing License Necessary for Gastrointestinal manometric catheter, electronic?

Obtaining a manufacturing license is mandatory and carries significant importance. It is the first step towards ensuring quality and safety in medical device production. A manufacturing license helps in regulating the production process, providing assurance about the medical device's standard and reliability.

In the healthcare sector, regulatory compliance is of prime importance. It safeguards the consumers and patients from substandard products. In the case of Gastrointestinal manometric catheter, electronic, the situation is no different. Compliance with CDSCO's guidelines and obtaining a relevant manufacturing license ensures the production of high-quality medical devices.

The manufacturing license also plays a crucial role in building trust and confidence among consumers in the healthcare industry.

Steps to Obtain a CDSCO Manufacturing License for Gastrointestinal manometric catheter, electronic

Obtaining a manufacturing license primarily involves a few preparatory steps and documentation, followed by the application process.

Pre-requisites and Required Documentation:

Device Master File, Device Details, Quality Management Certificate, Site details form the significant portions of this documentation.

Application Process:

The process involves initial application submission, internal process, external audit if required, and approval.

This process ensures all necessary checks and balances are in place before granting a manufacturing license.

Frequently Asked Questions (FAQs)

Q1. What is risk class of Gastrointestinal manometric catheter, electronic as per Medical Device Rules, 2017?

The Gastrointestinal manometric catheter, electronic is a class B risk medical device as per Medical Device Rules, 2017.

Q2. What license is needed to manufacture Gastrointestinal manometric catheter, electronic?

An MD5 license is required to manufacture Gastrointestinal manometric catheter, electronic.

Q3. What is fees for MD5 license for Gastrointestinal manometric catheter, electronic?

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

Q4. Who will issue manufacturing license for Gastrointestinal manometric catheter, electronic?

For class B devices, the state FDA will issue the license.

Q5. Is repackaging of Gastrointestinal manometric catheter, electronic considered manufacturing?

Yes, as per the Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing. By further definitions, medical devices are also drugs. Medical Device Rules have been made under the provisions of the Drug Act, and hence repackaging of Gastrointestinal manometric catheter, electronic is also considered manufacturing, requiring a license on MD5.

Conclusion

Navigating through the licensing process can be a complex task. We at Pharmadocx Consultants are available to assist you through this process. Reach out to us at "+91-7404557227" or drop an email at [email protected] for queries or consultation. Our team of experts can simplify the whole licensing process for you, ensuring you focus on creating world-class medical devices like Gastrointestinal manometric catheter, electronic.

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