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CDSCO Manufacturing License for Diskectomy system, percutaneous, automatic

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Introduction

Accomplishing excellent healthcare services and developing medical technology are significant factors in the rapidly evolving healthcare industry. The Central Drugs Standard Control Organization (CDSCO), India's principal drug regulation body, plays an essential role in ensuring safety and efficacy in medicines, vaccines, and other health products, including medical devices.

One such medical device that plays a pivotal role in the medical sector is a Diskectomy system, percutaneous, automatic. Before we dive into the specifics of this device, we recommend the readers acquaint themselves with the plethora of information present on the CDSCO's portal. You can visit their official website here.

What is Diskectomy System, Percutaneous, Automatic?

A Diskectomy System, Percutaneous, Automatic, is a surgical device utilized by surgeons to remove the damaged part of a herniated disc in your spine. This system is often used in procedures that involve the removal of the nucleus pulposus from the lumbar disc, often with the objective to relieve pressure off a nerve root or the spinal cord.

This device proves to be crucial as it provides an invasive solution to offer relief to patients suffering from severe back pain or other debilitating symptoms caused by a disc herniation that hasn't responded to conservative treatments.

The Role of CDSCO in Medical Device Regulation

CDSCO's primary mission includes ensuring that the drugs, vaccines, and medical devices available to the nation are safe, effective, and conform to accepted standards of quality. It protects the nation's health care system by implementing the Drugs and Cosmetics Act, 1940.

An integral part of the regulatory framework CDSCO follows is the classification of medical devices based on their associated risk and specific controls necessary to ensure safety and effectiveness.

How to manufacture Diskectomy System, Percutaneous, Automatic

The manufacturing of Diskectomy System, Percutaneous, Automatic involves complex procedures that adhere to medical standards. Each part of the system must be appropriately assembled to ensure the safety and effectiveness of the device.

Fees for manufacturing license for Diskectomy System, Percutaneous, Automatic

Given that the Diskectomy System, Percutaneous, Automatic falls under the Class-D risk category, it requires an MD9 license for manufacturing. The license fees for MD9 are Rs.50,000, and an additional Rs.1,000 is charged per product.

For more detailed information on the licensing procedure, follow this link.

Why is a Manufacturing License Necessary for Diskectomy System, Percutaneous, Automatic?

Manufacturing licenses are mandatory for ensuring quality control and maintaining high safety standards in the production of medical devices. The CDSCO and state FDA closely monitor this to prevent substandard products in the market. It also helps maintain regulatory compliance, thereby promoting public health and consumer protection.

Steps to Obtain a CDSCO Manufacturing License for Diskectomy System, Percutaneous, Automatic

Obtaining a license can be daunting. However, knowing some pre-requisites and the application process can make this easier:

  1. Prepare the necessary documents, which include a Device Master File, Quality Management Certificate, Device and Site Details, etc.
  2. Submission of the application and the prepared documents
  3. Wait for approval by authorities.
  4. Overcome challenges with professional guidance.

Frequently Asked Questions (FAQs)

  1. Q: What is the risk class of Diskectomy System, Percutaneous, Automatic as per Medical Device Rules, 2017? The Diskectomy System, Percutaneous, Automatic, falls under Risk Class D.

  2. Q: What license is needed to manufacture Diskectomy System, Percutaneous, Automatic? An MD9 license is required to manufacture Diskectomy System, Percutaneous, Automatic.

  3. Q: What is the fee for an MD9 license for Diskectomy System, Percutaneous, Automatic? The fee for an MD9 License is Rs.50,000, with an additional charge of Rs.1,000 per product.

  4. Q: Who will issue the manufacturing license for Diskectomy System, Percutaneous, Automatic? The manufacturing license for Class D devices like the Diskectomy System, Percutaneous, Automatic, is issued by the CDSCO HQ in New Delhi.

  5. Q: Is the repackaging of Diskectomy System, Percutaneous, Automatic considered manufacturing? Yes, the repackaging of Diskectomy System, Percutaneous, Automatic, is considered manufacturing and requires an MD9 license according to the risk class.

Conclusion

Navigating complex regulations to obtain licenses can be challenging. However, the experts at Pharmadocx Consultants simplify this process. You can reach out to Pharmadocx Consultants via their website, call at "+91-7404557227" or email at [email protected] for assistance or consultation.

Remember, manufacturing a medical device is not only about adhering to stringent medical standards and regulations but also defines the health and wellbeing of numerous individuals relying on it.

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