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CDSCO Manufacturing License for Radiological computer aided triage and notification software

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Introduction

The Central Drugs Standard Control Organization (CDSCO) plays a pivotal role in ensuring the quality, safety, and efficacy of medical devices. This organization governs the standards for medical products and oversees the compliance of manufacturing processes with these standards. Furthermore, it ensures the protection of public health by regulating the marketing of medical devices in India.

Manufacturing licenses are critical in the medical device industry. Not only do they serve as a quality assurance measure but they also lay the foundation required for meeting various regulatory standards.

In this article, we will delve into the intricacies of manufacturing licenses specifically for Radiological Computer Aided Triage and Notification Software, a class C device under the purview of CDSCO. This software is profound in its medical significance, particularly aiding in the prioritization and triage of radiological medical images.

You can find more information on the CDSCO's official portal here

What is Radiological Computer Aided Triage and Notification Software?

Radiological Computer Aided Triage and Notification Software is an image processing prescription device. It is designed to assist clinicians in prioritizing and triaging radiological medical images. The software performs a computer-aided analysis of the images and notifies a pre-determined list of clinicians about the availability of these images for review.

Common uses of this software include diagnosis support for a variety of medical conditions, such as assessing severity and tracking changes over time.

The Role of CDSCO in Medical Device Regulation

CDSCO plays an integral role in ensuring the quality, safety, and effectiveness of medical devices. It oversees the implementation of the regulatory framework for medical devices and enforces compliance with these regulations.

How to manufacture Radiological Computer Aided Triage and Notification Software

The software falls under the Class C category, which means manufacturing it requires an MD9 license, following the CDSCO guidelines. This process involves ensuring that the software complies with the necessary regulations, meets the quality standards, and ultimately serves its medical purpose without compromising user safety.

Fees for manufacturing license for Radiological Computer Aided Triage and Notification Software

Given that the software is a Class C medical device, it requires an MD9 license. The fees for an MD9 license are Rs. 50,000 for the license and Rs. 1,000 per product.

Why is a Manufacturing License Necessary for Radiological Computer Aided Triage and Notification Software

Manufacturing licenses are mandatory for Class C devices like this one. They not only validate the integrity of the product but also ensure the safety of the end-user. Furthermore, the regulatory compliance contributes significantly to the healthcare sector's robustness and credibility by deterring substandard products from entering the market.

Steps to Obtain a CDSCO Manufacturing License for Radiological Computer Aided Triage and Notification Software

Obtaining a manufacturing license from CDSCO involves the following steps:

  1. Collect the necessary documents: Device Master File, Quality Management Certificate, Device Details, Site details, etc.
  2. Submit your application
  3. Await review and feedback
  4. Finally, approval

For more detailed understanding of the MD9 process, you can read here.

Frequently Asked Questions (FAQs)

  1. What is the risk class of Radiological Computer Aided Triage and Notification Software as per Medical Device Rules, 2017? It falls under Class C as per the Medical Device Rules, 2017.

  2. What license is needed to manufacture Radiological Computer Aided Triage and Notification Software? An MD9 license is required for manufacturing the software.

  3. What are the fees for an MD9 license for Radiological Computer Aided Triage and Notification Software? The fees are Rs. 50,000 for the license and Rs. 1,000 per product.

  4. Who will issue a manufacturing license for Radiological Computer Aided Triage and Notification Software? The CDSCO HQ in New Delhi issues the license.

  5. Is repackaging of Radiological Computer Aided Triage and Notification Software considered manufacturing? 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 formulated under the provisions of the Drug Act. Hence, repackaging of the software also requires a license, specifically an MD9 for Class C devices.

Conclusion

Navigating through the intricate process of obtaining a manufacturing license for Class C medical devices like the Radiological Computer Aided Triage and Notification Software can be challenging. However, getting professional assistance can streamline the process and ease the complexity. Feel free to reach out to us at Pharmadocx Consultants for consultation or assistance regarding the licensing process. Visit our website here, call us at +91-7404557227, or drop an email to [email protected] for consultation or enquiries.

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