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CDSCO Manufacturing License for Stereotactic radiosurgical system

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Introduction

The Central Drugs Standard Control Organization (CDSCO) plays an indispensable role in the Indian healthcare ecosystem. Tasked with ensuring the quality of medical devices manufactured and sold in India, CDSCO's responsibilities extend across multiple facets of the health and medical spectrum. A primary facet of CDSCO's oversight involves the licensing of medical device manufacturing processes.

The medical device manufacturing industry is one of the most critical sectors in healthcare, providing indispensable tools and equipment for diagnostics, treatment, and patient care. Amongst the plethora of medical devices, Stereotactic radiosurgical system stands tall in terms of its medical importance.

The Stereotactic radiosurgical system is revolutionizing how tumors in the brain, neck, breast, and spine are treated, allowing physicians to deliver powerful therapeutic radiation doses with unbelievable accuracy. For information on CDSCO regulations pertaining to this device, visit the CDSCO's portal here CDSCO Portal.

What is Stereotactic radiosurgical system?

The Stereotactic radiosurgical system is a high-tech medical equipment designed to deliver therapeutic radiation doses to a specified region in an individual's anatomy. The system operates with multiple radionuclide sources that are arranged in a fixed focal point collimated array. This sophisticated arrangement is designed to target tumors with extreme precision.

Common procedures involving the Stereotactic radiosurgical system include treatments for brain, neck, breast, and spinal tumors where traditional surgical techniques may not be feasible or effective. In these cases, the Stereotactic radiosurgical system provides an efficient alternative treatment method.

The Role of CDSCO in Medical Device Regulation

Established as India's apex pharmaceutical and medical devices regulation organization, CDSCO's mission lies in ensuring quality and safety standards. Part of its mandate revolves around the structured regulation of medical devices.

CDSCO's regulatory framework for medical devices is comprehensive and designed to cater to varying levels of risks associated with different devices. It ensures that manufacturers adhere to stringent standards to ensure patient safety and the overall efficacy of these devices.

How to manufacture Stereotactic radiosurgical system

Fees for manufacturing license for Stereotactic radiosurgical system

As a Class D medical device, the manufacturing license required is MD9. The fees for this license is Rs. 50,000, with an additional Rs. 1,000 per product.

Why is a Manufacturing License Necessary for Stereotactic radiosurgical system?

Obtaining a manufacturing license for Stereotactic radiosurgical system is mandatory. It serves as a measure to ensure the quality and safety of the device and its manufacturing standards. The regulation is also critical in protecting consumers and patients, ensuring they do not fall prey to substandard products.

Compliance with regulatory standards plays a significant role in the healthcare sector. Following these ensures public trust and maintains the credibility of the medical industry.

Steps to Obtain a CDSCO Manufacturing License for Stereotactic radiosurgical system

Acquiring a CDSCO Manufacturing License comprises several steps which include:

  1. Preparation of required documentation such as the Device Master File, Quality Management Certification, detailed information about the device, and site particulars.
  2. Submitting the application and related documents.
  3. Navigating the approval process.
  4. Confronting and overcoming potential challenges in the approval process.

Frequently Asked Questions (FAQs)

Q1. What is risk class of Stereotactic radiosurgical system as per Medical Device Rules, 2017?

A1. Stereotactic radiosurgical system falls under the risk class D category.

Q2. What license in needed to manufacture Stereotactic radiosurgical system?

A2. The MD9 license is required to manufacture Stereotactic radiosurgical system.

Q3. What is fees for MD9 license for Stereotactic radiosurgical system?

A3. The fee for an MD9 license for Stereotactic radiosurgical system is Rs. 50,000, with an additional Rs. 1,000 per product.

Q4. Who will issue manufacturing license for Stereotactic radiosurgical system?

A4. For Class D devices like Stereotactic radiosurgical system, the CDSCO HQ in New Delhi will issue the manufacturing license.

Q5. Is repackaging of Stereotactic radiosurgical system considered manufacturing?

A5. Yes, as per Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing and by further definitions, medical devices are also drugs. Medical Device Rules have been made under the provisions of Drug Act only and hence repackaging of Stereotactic radiosurgical system is also considered manufacturing requiring a license on MD9.

Conclusion

Seeking to manufacture a medical device such as a Stereotactic radiosurgical system requires a thorough understanding of CDSCO's regulations. As the process involves several steps and compliance with numerous regulations, expert guidance is recommended.

You can reach out to Pharmadocx Consultants via their Website, call at +91-7404557227, or send an email to [email protected] for any consultation or assistance regarding the licensing process.

For more detailed information on the CDSCO MD9 manufacturing license for medical devices in India, visit this page where you can understand the process and requirements in greater detail.

Remember, being proactive in obtaining the right information and seeking professional guidance will ensure your venture into the manufacturing of medical devices is smooth and hassle-free.

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