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CDSCO Manufacturing License for Full-body MRI system, resistive magnet

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Introduction

The Central Drugs Standard Control Organization (CDSCO) is the apex regulatory body for maintaining the safety, efficacy, and quality of medical devices in India. The organization ensures that medical devices meet the approved standards before reaching the patients, thereby safeguarding the health and wellbeing of the country. One of the vital roles of CDSCO is issuing manufacturing licenses to various medical devices which ensure their quality and safety. A manufacturing license not only abides by the regulatory standards but also builds trust among the consumers about the safety and effectiveness of the medical device. One such significant medical device is the Full-body MRI system, resistive magnet.

The Full-body MRI system has proven to be one of the remarkable inventions in the field of medical science. It has a pivotal role in diagnosing various diseases by scanning any targeted area of the body with full-body imaging capabilities. For a detailed analysis of CDSCO's regulatory norms or to initiate the process of obtaining a manufacturing license, check out the CDSCO portal.

What is Full-body MRI system, resistive magnet?

The Full-body MRI system with resistive magnet is a diagnostic general-purpose magnetic resonance imaging (MRI) system. It is designed to scan any targeted area of the body providing a full-body imaging facility. The emphasis here is on a resistive magnet assembly, significant for high-resolution imaging. This system has transformed the diagnostic process by providing detailed images, aiding in the early detection and effective treatment of various medical conditions.

The Role of CDSCO in Medical Device Regulation

The CDSCO, under the Ministry of Health and Family Welfare, is known for the regulation of medical devices in India. It establishes directives, guidelines, and comprehensive regulatory frameworks for medical devices to ensure their quality, safety, and efficacy. The medical devices like Full-body MRI system, resistive magnet, classified under Class C are governed by the regulatory framework ensuring their proper manufacture, sale and distribution.

How to manufacture Full-body MRI system, resistive magnet?

To manufacture a full-body MRI system, a company has to apply for the MD9 license from the CDSCO. This is because the Full-body MRI system belongs to the class C risk category, which suggests that it could potentially cause significant harm to the patient if not used correctly. Therefore, strict regulatory measures are necessary to ensure proper quality control.

Fees for manufacturing license for Full-body MRI system, resistive magnet

The manufacturing license fee for a Class C device such as the Full-body MRI system, a resistive magnet, is Rs. 50,000 for the MD9 license, along with an additional Rs. 1,000 per product.

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

Acquiring a manufacturing license is mandatory for all medical devices, including the Full-body MRI System. It ensures safety and quality standards facilitating the production of reliable and efficient medical devices. It also reinforces the importance of regulatory compliance in healthcare which is critical in protecting patients from substandard products and maintaining their trust in the healthcare system.

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

Obtaining a manufacturing license involves several steps:

  1. The submission of required documents such as a Device Master File, Quality Management Certificate, Device Details, and Site details.
  2. Applying for the license via the CDSCO online portal.
  3. The application undergoes various checks for validation and approval.
  4. Once approved, the manufacturing license is issued.

Frequently Asked Questions (FAQs)

Q1. What is the risk class of the Full-body MRI system, resistive magnet, as per Medical Device Rules, 2017?

  • The Full-body MRI system, resistive magnet is a Class C device as per Medical Device Rules, 2017.

Q2. What license is needed to manufacture the Full-body MRI system, resistive magnet?

  • An MD9 license is required to manufacture the Full-body MRI system, resistive magnet.

Q3. What is the fees for an MD9 license for a Full-body MRI system, resistive magnet?

  • The fees for an MD9 license for a Full-body MRI system, resistive magnet is Rs. 50,000 plus Rs. 1,000 per product.

Q4. Who will issue the manufacturing license for a Full-body MRI system, resistive magnet?

  • The CDSCO HQ in New Delhi will issue the manufacturing license for a Full-body MRI system, resistive magnet.

Q5. Is repackaging of Full-body MRI system, resistive magnet considered manufacturing?

  • Yes, as per the Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing and by further definitions, medical devices are also drugs. Hence repackaging of Full-body MRI system, resistive magnet is also considered manufacturing requiring a license.

Conclusion

The CDSCO plays a pivotal role in ensuring the safety and efficacy of medical devices in India. While obtaining the manufacturing license for medical devices like Full-body MRI system, resistive magnet might seem challenging, it is essential for quality assurance. If you need assistance in understanding the regulatory norms or licensing process, feel free to reach out to Pharmadocx Consultants. Alternatively, you can call us on +91-7404557227 or write to us at [email protected].

For a detailed explanation of the MD9 License Procedure, visit MD9 License Consultation.

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