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CDSCO Manufacturing License for Gastrointestinal manometric catheter, non- electronic

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Introduction

The Central Drugs Standard Control Organization (CDSCO) plays an instrumental role in maintaining the safety, quality and efficacy of medicinal products and devices in India. Like any other country, manufacturing licenses are of great significance in the Indian medical device industry. They reflect the regulatory compliance of a manufacturer and signify the quality of the produced devices.

In this blog post, we are going to discuss the Gastrointestinal manometric catheter, non- electronic, a Class B medical device, predominantly utilized in gastroenterology. This device aids in the diagnosis and evaluation of diverse gastrointestinal disorders. We'll be discussing more in-depth about its intended use, manufacturing requirements, regulation, license costs and more. Please make sure to check the CDSCO's portal here for additional details.

What is Gastrointestinal manometric catheter, non- electronic?

A Gastrointestinal manometric catheter, non- electronic is a flexible tube, which is inserted either through nose or rectum into the gastrointestinal (GI) tract. This device measures the pressure and assesses the peristaltic motility in the GI tract. It is commonly employed to evaluate a variety of GI disorders like gastro-oesophageal reflux disease (GERD), faecal incontinence. Furthermore, this catheter helps in the assessment of rectal musculature and anal sphincter functions.

The Role of CDSCO in Medical Device Regulation

The Central Drugs Standard Control Organization (CDSCO) was set up with a mission to safeguard public health by ensuring the safety, efficacy, and quality of the medical devices and drugs. CDSCO's regulatory framework for medical devices is built on robust principles, which assure the manufacturing and circulation of safe medical devices.

How to manufacture Gastrointestinal manometric catheter, non- electronic

The manufacturing process of a Gastrointestinal manometric catheter involves precise steps for ensuring the quality and safety. For Class B device like this, an MD5 license is mandatory.

Fees for manufacturing license for Gastrointestinal manometric catheter, non- electronic

As per the CDSCO guidelines for a Class B medical device, the required licensing fee is Rs. 5,000 and additional Rs. 500 per product for the MD5 license. You can find more about MD5 license here

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

It's mandatory to obtain a manufacturing license. It's crucial for maintaining product quality and safety in medical device production. Adherence to regulations is of fundamental importance in healthcare. It protects consumers and patients against substandard devices.

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

  1. Compile the necessary documentation including Device Master File, Quality Management Certificate, Device Details and Site details.
  2. Submit your application to the relevant authority following the defined procedures.
  3. Await approval, which might require meeting specific criteria and possibly overcoming common challenges.
  4. Receive the license upon successful approval of the application.

Frequently Asked Questions (FAQs)

Q1. What is the risk class of Gastrointestinal manometric catheter, non- electronic as per Medical Device Rules, 2017? Answer: The risk class of Gastrointestinal manometric catheter, non- electronic is Class B.

Q2. What license is needed to manufacture Gastrointestinal manometric catheter, non- electronic? Answer: To manufacture Gastrointestinal manometric catheter, non- electronic, an MD5 license is required.

Q3. What is the fee for MD5 license for Gastrointestinal manometric catheter, non- electronic? Answer: The fee for MD5 license is Rs. 5,000 and an additional Rs. 500 per product.

Q4. Who will issue the manufacturing license for Gastrointestinal manometric catheter, non- electronic? Answer: The state FDA will issue the license for Class B devices like Gastrointestinal manometric catheter, non- electronic.

Q5. Is repackaging of Gastrointestinal manometric catheter, non- electronic considered manufacturing? Answer: Yes, as per the Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing and by further definitions, medical devices are also considered drugs. Hence, it requires an MD5 license.

Conclusion

Navigating the licensing process for medical devices can be complex and time-consuming. If you are looking for consultation or assistance in this matter, don't hesitate to reach out to Pharmadocx Consultants or call on +91-7404557227 or you can email to [email protected]. Their expert team can guide you in the right direction, ensuring a smoother approval process.

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