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CDSCO Manufacturing License for Biliary manometric catheter

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Introduction

CDSCO or the Central Drugs Standard Control Organization is a body under the Ministry of Health and Family Welfare which regulates the standards and safety of drugs and medical devices in India. Manufacturing licenses, authorized by the CDSCO, are crucial to gauge the reliability and safety of these medical devices. One such critical medical device is the Biliary manometric catheter, integral to the field of gastroenterology. You can get detailed information from the official CDSCO portal at https://cdscomdonline.gov.in/NewMedDev/Homepage

What is a Biliary Manometric Catheter?

A Biliary manometric catheter is a sterile, non-electrical flexible tube used for measuring pressures within the ducts of the biliary tree. It is especially significant to evaluate sphincter Oddi function. These catheters are commonly used in several diagnostic procedures in the field of gastroenterology.

The Role of CDSCO in Medical Device Regulation

The Central Drugs Standard Control Organization (CDSCO) is responsible for setting the safety standards and regulations for drugs and medical devices in India. It provides an organized framework for overseeing medical devices, including licenses and guidelines for manufacturing such devices.

How to Manufacture a Biliary Manometric Catheter

Manufacturing medical devices like a Biliary manometric catheter requires a Class B risk license as they are categorized as the medium risk devices. Sterile production environments, refining and assembly processes, testing for safety and functionality, and quality assurance are essential elements in the production process.

Fees for the Manufacturing License for a Biliary Manometric Catheter

The fees for MD5 license required to manufacture a Biliary Manometric Catheter is Rs. 5,000 for the license and Rs. 500 per product.

Why is a Manufacturing License Necessary for a Biliary Manometric Catheter?

Obtaining a manufacturing license is mandatory by law for medical devices. It ensures that quality and safety measures are adhered to in the manufacturing process. Regulatory compliance is essential in health-care sectors to protect consumers and patients from subpar products.

Steps to Obtain a CDSCO Manufacturing License for a Biliary Manometric Catheter

The prerequisites involves documentation including Device Master File, Quality Management Certificate, Device Details, Site details and others. Follow a four-step process which includes preparing required documents, application submission, review and reply to inquiries, and finally, license approval. More details can be found in the linked article.

Frequently Asked Questions (FAQs)

  1. What is the risk class of a Biliary Manometric Catheter as per the Medical Device Rules, 2017?
    A Biliary Manometric Catheter falls under the Class B risk class.
  2. What license is needed to manufacture a Biliary Manometric Catheter? The MD5 license is needed for manufacturing a Biliary Manometric Catheter.
  3. What is the fees for MD5 license for a biliary manometric catheter?
    The fee is Rs.5000 for the license and Rs. 500 per product.
  4. Who will issue the manufacturing license for a Biliary Manometric Catheter? For Class A sterile and measuring & Class B devices like the Biliary Manometric Catheter, the license is granted by the state FDA.
  5. Is repackaging of a Biliary Manometric Catheter considered manufacturing? Yes, repackaging of Biliary Manometric Catheter, alike other medical devices, is considered manufacturing. It requires an MD5 license as per the Drugs and Cosmetics Act and the Medical Device Rules.

Conclusion

Completing the procedure for a manufacturing license can be a daunting task. Pharmadocx Consultants are ready to guide you through this process. Reach out for consultation via our website "https://www.pharmadocx.com", or call "+91-7404557227" or email to "[email protected]".

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