CDSCO Manufacturing License for Radiological computer- assisted diagnostic software for lesions suspicious of cancer

Introduction

The Central Drugs Standard Control Organization (CDSCO) is the national regulatory authority, which oversees the safety, efficacy, and quality of medical devices in India. It is the central regulatory body for pharmaceuticals and medical devices, responsible for stringent monitoring and control over the manufacturing, sale, and distribution of both the pharmaceutical and medical devices. The Organization plays an essential role in safeguarding public health.

Manufacturing licenses hold significant importance in the medical device industry. Obtaining necessary licenses for medical devices ensures adherence to defined regulatory standards which further establish safety, effectiveness, and quality performance. The license acquisition process necessitates strict abidance by the rules and guidelines set forth by the CDSCO.

Today, our focus is on "Radiological computer-assisted diagnostic software for lesions suspicious of cancer". It's a high-functioning medical device with paramount importance in oncology diagnostics. It has been designed to assist radiologists in accurately diagnosing the presence of potentially cancerous lesions.

For more information, please visit the CDSCO's official portal here.

• What is Radiological Computer-Assisted Diagnostic Software for Lesions Suspicious of Cancer?
• The Role of CDSCO in Medical Device Regulation
• How to Manufacture Radiological Computer-Assisted Diagnostic Software for Lesions Suspicious of Cancer
• Fees for Manufacturing License for Radiological Computer-Assisted Diagnostic Software for Lesions Suspicious of Cancer
• Why is a Manufacturing License Necessary for Radiological Computer-Assisted Diagnostic Software for Lesions Suspicious of Cancer?
• Steps to Obtain a CDSCO Manufacturing License for Radiological Computer-Assisted Diagnostic Software for Lesions Suspicious of Cancer
• Frequently Asked Questions (FAQs)
• Conclusion

What is Radiological Computer-Assisted Diagnostic Software for Lesions Suspicious of Cancer?

Radiological computer-assisted diagnostic software for lesions suspicious of cancer is an image processing prescription device. Its primary purpose is to aid in the characterizing of lesions as suspicious for cancer, identified on acquired medical images like magnetic resonance, mammography, radiography, or computed tomography.

This diagnostic software extracts features or information from these images and provides comprehensive information about the possible cancerous lesion(s). Consequently, it helps in implementing an effective and prompt therapeutic plan.

The Role of CDSCO in Medical Device Regulation

The foundation of CDSCO aims to bring effectiveness, safety, and quality in the country's healthcare services. It's equally essential to understand the role of CDSCO in the medical device regulation.

CDSCO governs the medical device sector by implementing a regulatory framework. The regulatory framework comprises the Medical Device Rules, 2017 (India MDR), which segregate medical devices into four classes—A, B, C, and D, according to the level of associated risk—A being the lowest and D being the highest.

How to Manufacture Radiological Computer-Assisted Diagnostic Software for Lesions Suspicious of Cancer

The manufacturing or production of Radiological Computer-Assisted Diagnostic Software for Lesions Suspicious of Cancer is a process that necessitates strict adherence to CDSCO guidelines and norms. An application for a manufacturing license should be submitted to the appropriate authority based on its risk category.

Fees for Manufacturing License for Radiological Computer-Assisted Diagnostic Software for Lesions Suspicious of Cancer

Being a Class C device, a MD9 license is needed for the manufacture of Radiological Computer-Assisted Diagnostic Software for Lesions Suspicious of Cancer. The fee for an MD9 license is Rs. 50,000, along with Rs. 1,000 per product. For detailed information please visit this link

Why is a Manufacturing License Necessary for Radiological Computer-Assisted Diagnostic Software for Lesions Suspicious of Cancer?

A manufacturing license is mandatory to ensure the quality, effectiveness, and safety in medical device production. The primary purpose is to maintain regulatory compliance in the healthcare sector and protect consumers and patients from receiving substandard products.

Steps to Obtain a CDSCO Manufacturing License for Radiological Computer-Assisted Diagnostic Software for Lesions Suspicious of Cancer

The procedure to obtain the manufacturing license would essentially involve these steps:

• Necessary documentation submission, such as Device Master File, Quality Management Certificate, Device Details, Site details, among others.
• Submission of the application to the appropriate regulatory body.
• Thorough verification and review by the officials.
• Approval of the submission and issuance of the manufacturing license.

Frequently Asked Questions (FAQs)

1. Q. What is the risk class of Radiological Computer-Assisted Diagnostic Software for Lesions Suspicious of Cancer as per Medical Device Rules, 2017?

   The Radiological Computer-Assisted Diagnostic Software for Lesions Suspicious of Cancer falls under the risk class C as per Medical Device Rules, 2017.

2. Q. What license is needed to manufacture Radiological Computer-Assisted Diagnostic Software for Lesions Suspicious of Cancer?

   A Class C medical device requires an MD9 license for manufacturing.

3. Q. What is the fee for an MD9 license for Radiological Computer-Assisted Diagnostic Software for Lesions Suspicious of Cancer?

   The fee for an MD9 license is Rs. 50,000, and Rs. 1,000 per product.

4. Q. Who will issue the manufacturing license for Radiological Computer-Assisted Diagnostic Software for Lesions Suspicious of Cancer?

   For class C medical devices, the CDSCO HQ in New Delhi will issue the license.

5. Q. Is repackaging of Radiological Computer-Assisted Diagnostic Software for Lesions Suspicious of Cancer 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. Medical Device Rules have been made under the provisions of Drug Act only, and hence repackaging of Radiological Computer-Assisted Diagnostic Software for Lesions Suspicious of Cancer is also considered manufacturing requiring a license on MD9.

Conclusion

The process of acquiring a manufacturing license for medical devices involves multiple procedures and close adherence to regulations. Pharmadocx Consultants offer consultancy services to assist you through the licensing process. Connect with us through our website or call us at +91-7404557227 or mail us at [email protected] for consultations or assistance. Your journey of medical device manufacturing license procurement is now just a click or a call away.