Published on

CDSCO Manufacturing License for Catheter-balloon inflator, single-use

Authors
  • avatar
    Name
    CDSCO Licenses Blog
    Twitter

Introduction

The Central Drugs Standard Control Organization (CDSCO) plays a crucial role in the healthcare system of India. It regulates the approval and circulation of medications, medical devices, clinical trials, and more to ensure their safety and effectiveness. Among these responsibilities, providing manufacturing licenses for medical devices is a critical task performed by the CDSCO. Manufacturing licenses ensure that the production of medical devices adheres to the quality guidelines and best practices, safeguarding the health and wellbeing of patients.

The medical device we are discussing here is the Catheter-balloon inflator, a Class B risk device used predominantly in Gastroenterology. This single-use device manually inflates and regulates the pressure of a balloon catheter during a medical procedure. This blog post will delve into the purpose, manufacturing, and licensing of the Catheter-balloon inflator as guided by the CDSCO. To know more about the CDSCO and its activities, visit here.

What is a Catheter-Balloon Inflator?

A Catheter-balloon inflator is a sterile device designed to manually inflate and regulate the pressure of a balloon catheter (e.g., by injecting and aspirating fluid or air within the balloon). It is also used to deflate the balloon during a medical procedure. Due to its critical nature in certain surgical procedures, it is categorized under a Class B risk device in India, whereby stringent manufacturing procedures and licenses are required.

The Role of CDSCO in Medical Device Regulation

CDSCO plays a fundamental role in regulating the sale and manufacture of drugs and medical devices in India. The rights and responsibilities have expanded over the years, and it now also oversees clinical trials, sets quality standards, and ensures the safety of drugs and devices reaching the market. Its regulatory framework ensures that the production of medical devices like the Catheter-balloon inflator maintain high standards of quality, thereby safeguarding patient safety and product effectiveness.

How to Manufacture a Catheter-Balloon Inflator

The manufacturing of a Catheter-balloon inflator involves meticulous processes considering its Class B risk categorization. A legitimate and stringent production process is essential to maintain the device's quality and safety. The manufacturing of these devices involves a multi-step process, which includes the creation of the balloon, the creation of the catheter, and the assembly of these components into the final product.

Fees for Manufacturing License for a Catheter-Balloon Inflator

As a Class B risk device, the manufacture of a Catheter-balloon inflator requires an MD5 license. The fee for obtaining this license is Rs. 5,000, and an additional Rs. 500 per product is charged.

Why is a Manufacturing License Necessary for a Catheter-Balloon Inflator?

As a medical device used in crucial medical procedures, it is mandatory to have a manufacturing license for a Catheter-balloon inflator to ensure its safety and effectiveness. A license ensures that the manufacturer follows the best practices and maintains high-quality standards in the production process. Additionally, it ensures that manufacturers comply with necessary regulations, thus protecting the patients from substandard products.

Steps to Obtain a CDSCO Manufacturing License for a Catheter-Balloon Inflator

Obtaining a manufacturing license involves certain pre-requisites, such as a Device Master File, Quality Management Certificate, Device Details, Site details, etc. The application process starts with submission and evolves with several approving stages, making it a test of the manufacturer's credentials. For a detailed outlook on the process do refer to this article.

Frequently Asked Questions (FAQs)

Q1. What is the risk class of Catheter-Balloon Inflator as per Medical Device Rules, 2017?

  • A. The Catheter-Balloon Inflator falls under Class B.

Q2. What license is needed to manufacture Catheter-Balloon Inflator?

  • A. An MD5 license is required to manufacture a Catheter-Balloon Inflator.

Q3. What is the fees for MD5 license for Catheter-Balloon Inflator?

  • A. The fees for MD5 license is Rs. 5,000, along with an additional Rs. 500 per product.

Q4. Who will issue the manufacturing license for Catheter-Balloon Inflator?

  • A. For Class B devices like the Catheter-Balloon Inflator, the state FDA will issue the license.

Q5. Is repackaging of Catheter-Balloon Inflator 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 Catheter-Balloon Inflator is also considered manufacturing requiring a license on MD5.

Conclusion

Proper licensing is crucial in the medical device industry. It ensures the safety, quality, and effectiveness of medical devices like the Catheter-Balloon Inflator. The process may seem daunting but reaching out to experts can simplify the course for you.

Pharmadocx Consultants can provide guidance and assistance throughout the licensing process or answer any further queries. Feel free to reach out via their website, call on +91-7404557227, or email at [email protected] for a comprehensive consultation.

cdsco import license in india banner
cdsco manufacturing license in india banner