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CDSCO Manufacturing License for Radionuclide dose calibrator

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Introduction

The Central Drugs Standard Control Organization (CDSCO) is India's national regulatory authority for pharmaceuticals and medical devices. The organization's core function involves the approval of new drugs and clinical trials, laying down standards for drugs, control over the quality of drugs and cosmetics, implementation of a robust medical device licensing and regulatory regime, among others.

An essential component of the medical device industry is the requisite manufacturing licenses, which are vital in determining the safety, efficacy, and quality of these devices. Amongst these, is the Radionuclide dose calibrator, a device of crucial medical significance. A direct link to the CDSCO's portal, which provides detailed information pertaining to the organization and its operations, can be found here

What is a Radionuclide dose calibrator?

A radionuclide dose calibrator is a radiation detection device aimed at measuring the radioactivity levels of radionuclides before they are administered to patients. Its primary purpose is to ensure precise dosage of radioactive drugs. The device is an indispensable instrument in nuclear medicine departments and radiation therapy centres where it primarily aids in cancer treatments by ensuring patients receive the correct dosage of radiopharmaceuticals.

The Role of CDSCO in Medical Device Regulation

CDSCO is instrumental in laying down the standards and regulatory framework for medical devices in the country. It ensures that these devices conform to international standards of safety and efficiency. For instance, the medical devices are segregated into four risk classes - A, B, C, D, where Class A is the lowest risk, and Class D is the highest.

How to manufacture a Radionuclide dose calibrator

The manufacturing of a Radionuclide dose calibrator involves specific and intricate steps, adhering to stringent standards set by the CDSCO.

Fees for manufacturing license for Radionuclide dose calibrator

As per the risk classification, a Radionuclide dose calibrator falls under Class B risk. Therefore, an MD5 license is needed to manufacture it. The fee for obtaining an MD5 license is Rs. 5,000 and Rs. 500 per product. For detailed information on MD5 licenses follow this link

Why is a Manufacturing License Necessary for a Radionuclide dose calibrator?

Procuring a manufacturing license is mandatory in order to ensure the quality and safety of medical device production. The license guarantees that the medical devices produced adhere to the rigorous standards established by regulatory bodies. This safeguards patients and consumers from substandard products and institutes responsibility and compliance among manufacturers in the healthcare sector.

Steps to Obtain a CDSCO Manufacturing License for a Radionuclide dose calibrator

For procuring a license, the following requisites and documentation are needed - Device Master File, Quality Management Certificate, Device Details, Site details, etc.

The application process is a streamlined procedure that involves submission of the necessary documentation, following which, the approval process is undertaken.

Certain challenges may arise during this process. However, with appropriate planning and adherence to guidance, these challenges can be handled effectively.

Frequently Asked Questions (FAQs)

Q.1. What is the risk class of a Radionuclide dose calibrator as per Medical Device Rules, 2017?

The Radionuclide dose calibrator falls under Class B as per the Medical Device Rules, 2017.

Q2. What license is needed to manufacture a Radionuclide dose calibrator?

The MD5 license is required to manufacture a Radionuclide dose calibrator.

Q3. What is the fee for an MD5 license for a Radionuclide dose calibrator?

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

Q4. Who will issue the manufacturing license for a Radionuclide dose calibrator?

The manufacturing license for a Class B device like a Radionuclide dose calibrator will be issued by the state FDA.

Q5. Is repackaging of a Radionuclide dose calibrator considered as manufacturing?

Yes, repackaging of a Radionuclide dose calibrator is considered manufacturing as per the Drugs and Cosmetics Act's definition. It requires an MD5 license.

Conclusion

Acquiring a manufacturing license for medical devices is a complex procedure that requires thorough understanding and adherence to regulatory guidelines. Therefore, it's highly recommended to consult with experts who can ease the process. Pharmadocx Consultants are readily available to assist you in navigating the application procedure and provide consultation. You can reach out online, call "+91-7404557227", or send an email to "[email protected]".

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