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CDSCO Manufacturing License for Six axis correction apparatus with software

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Introduction

The Central Drugs Standard Control Organization (CDSCO) plays a multifaceted role in the Indian healthcare sector. It is responsible for setting the guidelines for drug safety, approving new drugs and pharmaceuticals, drafting the standards for drugs, regulating the market to ensure the availability of quality medical products and controlling over-the-counter medications and medical devices in India.

Manufacturing licenses are a significant aspect of the medical device industry. The license serves as a guarantee of safety and quality, ensuring the product is manufactured following the required standard. The process is legally binding for manufacturers, making it crucial for you to obtain a license if you plan to manufacture a medical device in India.

We will now introduce the Six axis correction apparatus with software, a Class B medical device. This apparatus and the accompanying software serve as a multi-planar correction system for deformities or fractures. This medical device has a notable impact on the orthopedic field, providing effective solutions for complex problems.

Detailed information about the device and its licensing process can be found on CDSCO's portal here.

What is a Six Axis Correction Apparatus with Software?

This medical device comprises struts, C/Y plate connector, labels for struts, clamps, rings, wires, and screws. It is designed and used for the correction of multi-plane deformities or fractures involving bone structures.

The software accompanying the apparatus navigates the correction process, providing an interface for data entry, generation of treatment plans, and more. This combination provides an effective solution to some of the most challenging problems in orthopedics and contributes significantly to patient recovery and the quality of life post the operation.

The Role of CDSCO in Medical Device Regulation

The CDSCO has a critical role to ensure the safety and efficacy of various healthcare products, including drugs, vaccines, and medical devices. Its mission focuses on the provision of affordable healthcare, access to quality drugs and medical devices, and promoting public health.

A significant part of CDSCO's work involves the regulation of medical devices. They assess the risks associated with new devices, approve them for use, monitor their safety, and control their market availability. CDSCO underlines the importance of manufacturing licenses for these devices, ensuring that quality and safety standards are met.

How to Manufacture a Six Axis Correction Apparatus with Software?

The manufacture of a Six-axis correction apparatus with software involves a range of steps including designing the product, material selection, manufacturing the hardware components, development of software, stringent testing of components and the software functionality, assembly, and packaging.

In addition, manufacturers must comply with the regulations set forth by CDSCO, including applying for a manufacturing license and ensuring the quality of their product meets the appropriate standards.

Fees for Manufacturing License for Six Axis Correction Apparatus with Software

As a Class B device, the manufacturing license required is MD5. The fees associated with MD5 are Rs. 5,000 for the license and an additional Rs. 500 per product item.

Why is a Manufacturing License Necessary for a Six Axis Correction Apparatus with Software?

Acquiring a manufacturing license is mandatory under Indian law for any company manufacturing medical devices. The license acts as a guarantee of quality and safety in medical device production and ensures the manufacturer's compliance with regulatory norms.

Obtaining this license is particularly significant in the healthcare sector, as it protects consumers and patients from substandard products that could potentially cause harm.

Steps to Obtain a CDSCO Manufacturing License for a Six Axis Correction Apparatus with Software

  1. Prepare all requisite documentation, including Device Master File, Quality Management Certificate, Device Details, Site Details, etc.
  2. Compile all requisite information and submit it to the relevant authority.
  3. Follow the defined process and comply with the rules and regulations set by the CDSCO.
  4. After successful validation and review of the application, the license approval is granted.

It's worth noting that there might be challenges during the application process; however, most of these can be overcome with the right guidance and advice.

Frequently Asked Questions (FAQs)

Q1. What is the risk class of a Six Axis Correction Apparatus with Software as per Medical Device Rules, 2017?

The Six Axis Correction Apparatus with Software is classified as a Class B device.

Q2. What license is needed to manufacture a Six Axis Correction Apparatus with Software?

The manufacturing license required for this device is MD5.

Q3. What are the fees for an MD5 license for the Six Axis Correction Apparatus with Software?

The fees for an MD5 license are Rs. 5,000, with an additional Rs. 500 per product.

Q4. Who will issue the manufacturing license for a Six Axis Correction Apparatus with Software?

For Class B devices like the Six Axis Correction Apparatus with Software, the state FDA will issue the license.

Q5. Is repackaging of the Six Axis Correction Apparatus with Software considered manufacturing?

Yes. As per the Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing, and by extension, medical devices are also drugs. Therefore, repackaging the Six Axis Correction Apparatus with Software is considered manufacturing and will require an MD5 license.

Conclusion

As briefly outlined in this blog post, obtaining a CDSCO manufacturing license for medical devices like the Six Axis Correction Apparatus with Software can be a meticulous process. Proper guidance and legal expertise are crucial to navigate this process seamlessly.

Pharmadocx Consultants offers such guidance and assistance. Feel free to reach out to them via their website, call them at "+91-7404557227", or send an email to "[email protected]" for expert advice.

Also, you can read more about the MD5 License for Class B devices on this page on the Pharmadocx website.

Remember, navigating regulatory paths might seem daunting, but with the right advice, it doesn't have to be. Let experts help you ensure that you are compliant and that your product can be used to make the world better.

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