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CDSCO Manufacturing License for Percutaneous biliary biopsy procedure kit

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Introduction

The Central Drugs Standard Control Organization (CDSCO) is a vital body that plays a critical role in ensuring the safety, efficacy, and quality of medical devices in India. It has set standards and controls for the development, manufacture, and sale of medical equipment and pharmaceuticals. One area where CDSCO holds utmost importance is in its role of issuing manufacturing licenses for medical devices.

One such medical device is the Percutaneous Biliary Biopsy Procedure Kit. This kit plays a pivotal role in gastroenterology, aiding in the collection of tissue specimens from within the biliary duct system. Its importance underlines the need for proper manufacturing standards and controls as governed by the CDSCO.

More detailed information can be sourced from the CDSCO's portal here.

What is Percutaneous biliary biopsy procedure kit?

The Percutaneous Biliary Biopsy Procedure Kit is precisely as its name suggests- a kit or collection of sterile devices designed to aid in the extraction of tissue samples. The particular area of focus for this medical equipment is from within the biliary duct system.

This kit has significant utility within gastroenterology, with its common uses within procedures that involve fluoroscopic visualization for histological analysis within the biliary duct system.

The Role of CDSCO in Medical Device Regulation

The formation of CDSCO marked a major milestone in the standardization of pharmaceutical and medical equipment production in India. With its mission to safeguard and enhance public health in India, CDSCO has always made it a priority to regulate the manufacture and distribution of drugs, cosmetics, and medical devices in the country.

A key aspect of CDSCO's regulatory contribution is in the implementation of its licensing system for manufacturing medical devices. Medical devices are categorized into four risk class categories: Class A, B, C, and D, with Class A being the lowest risk, and Class D being the highest.

How to manufacture Percutaneous biliary biopsy procedure kit

With its classification as a Class B medical device, the Percutaneous Biliary Biopsy Procedure Kit has specific manufacturing guidelines. To ensure safety standards, it must be produced under the watchful regulation and licensing of a governing body- in this case, the CDSCO.

Fees for manufacturing license for Percutaneous biliary biopsy procedure kit

For manufacturing the Percutaneous biliary biopsy procedure kit, a Class B device, a MD5 License is required. The fees for acquiring an MD5 license amounts to Rs. 5,000 and an additional Rs. 500 for each kit produced.

Why is a Manufacturing License Necessary for Percutaneous biliary biopsy procedure kit?

Ensuring that the Percutaneous Biliary Biopsy Procedure Kit is produced under a Manufacturing License is not only a mandatory requirement but is also vital for maintaining quality and safety.

Regulatory compliance, in this case, improves reliability and ensures that patients and consumers are protected from substandard products. It emphasizes the significance of quality assurance and safety in the medical devices industry, particularly in high-risk sectors such as gastroenterology.

Steps to Obtain a CDSCO Manufacturing License for Percutaneous biliary biopsy procedure kit

The process to obtain a CDSCO Manufacturing License involves several steps and requires specific documentation, including Device Master File, Quality Management Certificate, Device Details, Site details, among others.

The application process can be summarised in four stages:

  1. Documents submission
  2. Review by regulatory body
  3. Addressing potential issues
  4. Receiving approval

However, overcoming the common challenges involved in this process requires expert guidance and assistance.

Frequently Asked Questions (FAQs)

Q. What is the risk class of Percutaneous biliary biopsy procedure kit as per Medical Device Rules, 2017?

A. The Percutaneous biliary biopsy procedure kit is classified as a Class B medical device.

Q. What license is needed to manufacture Percutaneous biliary biopsy procedure kit?

A. A MD5 License is required to manufacture Percutaneous biliary biopsy procedure kit.

Q. What is the fees for MD5 license for Percutaneous biliary biopsy procedure kit?

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

Q. Who will issue the manufacturing license for Percutaneous biliary biopsy procedure kit?

A. The state FDA will issue the manufacturing license for Percutaneous biliary biopsy procedure kit.

Q. Is repackaging of Percutaneous biliary biopsy procedure kit 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. The Medical Device Rules have been made under the provisions of the Drug Act only and hence repackaging of Percutaneous biliary biopsy procedure kit is also considered manufacturing, requiring a license on MD5.

Conclusion

Getting a CDSCO manufacturing license for a medical device like a Percutaneous Biliary Biopsy Procedure Kit may seem complex and daunting. That's where Pharmadocx Consultants can make a difference! Our experts can guide you through the process, offer assistance, and make the path to approval smoother. To learn more about how we can help, visit here or call us at +91-7404557227. If you prefer to email, please do so at [email protected]. Feel free to reach out to us with any questions, large or small. We are here to assist you!

To learn more about the MD5 License process for Class A and B medical devices like the Percutaneous Biliary Biopsy Procedure Kit, you can check here.

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