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CDSCO Manufacturing License for Full-body MRI system, superconductin g magnet

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Introduction

Central Drugs Standard Control Organization (CDSCO) is the chief regulatory authority for pharmaceuticals and medical devices in India. One of its major responsibilities is to standardize the medical devices market by approving the license of products. In the field of medical device production, obtaining these manufacturing licenses plays a crucial part to ensure the safety and quality of the products being supplied to the general public.

Furthermore, we are about to delve into the unique world of Full-body MRI system, superconducting magnet, a type of Class-C medical device under CDSCO's classification system. With a deep insight into the world of CDSCO and the importance of product manufacturing licensing, you can find all the needed information on CDSCO's portal here.

What is Full-body MRI system, superconducting magnet?

A full-body MRI system with a superconducting magnet is a state-of-the-art medical imaging device. This powerful tool with an entire body scanning capability uses a strong magnetic field and computer-generated radio waves to create detailed images of the body. Thanks to its high-resolution imaging feature, it allows clinicians to diagnose a plurality of medical conditions early and accurately.

It is commonly used for detecting tumors, imaging blood vessels, identifying heart conditions, visualizing spinal cord injuries, and a horde of other medical uses. Not only does it help in the diagnosis of certain conditions, but it is also instrumental in monitoring the progress of treatment for certain disorders.

The Role of CDSCO in Medical Device Regulation

Established to uphold safety, efficacy, and quality in the healthcare sector, CDSCO is the apex regulatory body for pharmaceuticals and medical devices in India. The organization administers the Drugs and Cosmetics Act, which extends to the production, sale, and distribution of drugs and medical devices.

In particular, CDSCO is responsible for the regulation and oversight of the medical device industry. It sets standards and guidelines to ensure that medical devices, such as the Full-body MRI system, superconducting magnet, are produced and distributed according to regulatory compliances, ensuring patient safety.

How to Manufacture Full-body MRI system, superconducting magnet

The Class C devices, which the Full-body MRI system falls under, requires MD9 license from CDSCO for manufacturing. Production of these devices adheres strictly to ISO 13485, which is the universally accepted standard for a quality management system in the medical device industry.

Steps involved in the manufacturing process include the following:

  1. Design and Development
  2. Manufacturing
  3. Inspection and Testing
  4. Packaging

Each step is scrutinized to ensure stringent quality control and meet international standards of production.

Fees for Manufacturing License for Full-body MRI system, superconducting magnet

The cost of obtaining an MD9 license is ₹50,000 while an additional ₹1,000 is charged for every product.

Why is a Manufacturing License Necessary for Full-body MRI system, superconducting magnet?

A manufacturing license is necessary to uphold standards of quality, safety and efficacy. Regulatory compliance is paramount in the healthcare sector, and this governs every step of the manufacturing process. Moreover, a license also helps to protect consumers and patients from substandard products, ensuring their safety and well-being.

Steps to Obtain a CDSCO Manufacturing License for Full-body MRI system, superconducting magnet

  1. Prepare and compile necessary documents such as Device Master File, Quality Management Certificate, Device Details, Site details etc.
  2. Submit the documents along with the application for manufacturing license.
  3. The application is then reviewed and inspected by relevant authorities.
  4. Upon successful review, the manufacturing license is approved.

For more details, you can visit the following link.

Frequently Asked Questions (FAQs)

Q. What is the risk class of Full-body MRI system, superconducting magnet as per Medical Device Rules, 2017?

A. The risk class of Full-body MRI system, superconducting magnet is Class C.

Q. What license is needed to manufacture Full-body MRI system, superconducting magnet?

A. MD9 license is needed for the manufacturing of Class C devices which includes Full-body MRI system, superconducting magnet.

Q. What is the fees for MD9 license for Full-body MRI system, superconducting magnet?

A. An MD9 license costs ₹50,000 and an additional ₹1,000 is charged per product.

Q. Who will issue manufacturing license for Full-body MRI system, superconducting magnet?

A. The Manufacturing license for class C devices like Full-body MRI system, superconducting magnet will be issued by CDSCO HQ in New Delhi.

Q. Is repackaging of Full-body MRI system, superconducting magnet considered manufacturing?

A. Yes, as per Drugs and Cosmetics Act's definition of manufacturing, repackaging is considered manufacturing. Hence, repackaging of Full body MRI system, superconducting magnet is also considered manufacturing requiring a license on MD9.

Conclusion

The process of obtaining a manufacturing license for medical devices can be intricate and challenging. We at Pharmadocx Consultants, with our expert knowledge and experience, can guide you smoothly through the entire process. For any further queries or consultations, visit our website "Pharmadocx Consultants", call us on "+91-7404557227", or send us an email to "[email protected]".

Remember, the safety and efficacy of medical devices are of utmost importance for the welfare of the general public, and your adherence to the regulatory norms ensures just that.

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