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CDSCO Manufacturing License for Implanted spinal cord stimulator for bladder evacuation.

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Introduction

The Central Drugs Standard Control Organization (CDSCO) is India's leading regulatory body for the healthcare industry, tasked with ensuring public safety by overseeing the development and distribution of drugs, vaccines, and medical devices. The proper manufacturing licenses guarantee that products offered in the healthcare sector are consistent in their quality and effectiveness and meet the highest standards of safety.

An essential tool for our public health system is the Implanted Spinal Cord Stimulator for Bladder Evacuation. It empowers paraplegic patients who have a complete transection of the spinal cord, enabling them to regain control over their lives with improved hygiene and comfort. For detailed information on various medical devices, please visit CDSCO's portal.

What is the Implanted Spinal Cord Stimulator for Bladder Evacuation?

The Implanted Spinal Cord Stimulator for Bladder Evacuation is a medical device that uses electrical stimulation to prompt bladder emptying in paraplegic patients. The device consists of an implanted receiver with electrodes that are positioned on the conus medullaris section of the patient's spinal cord and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver.

This innovative medical device has become a critical resource for patients unable to naturally empty their bladders due to spinal cord injuries or other neurological issues. Its use has prevented complications such as urinary tract infections and renal failure, and improved the overall quality of life for these patients.

The Role of CDSCO in Medical Device Regulation

With patient safety and wellbeing at its core, CDSCO's mission is primarily to safeguard and enhance public health by guaranteeing that accessible healthcare products are safe, effective, and fulfill international standards of quality. The regulatory framework for medical devices under CDSCO guides manufacturers in establishing protocols and safety measures with rigorous compliance requirements. It enforces strict standards for quality and safety and assures that medical devices like the Implanned Spinal Cord Stimulator for Bladder Evacuation meet these requirements to mitigate risks to patients.

How to manufacture the Implanted Spinal Cord Stimulator for Bladder Evacuation

Fees for manufacturing licenses for the Implanted Spinal Cord Stimulator for Bladder Evacuation

The manufacturing license needed for Class D medical devices such as the Implanted Spinal Cord Stimulator for Bladder Evacuation is the MD9. With a fee of Rs. 50,000 for the license and an additional Rs. 1,000 per product, manufacturers can apply for the MD9 license.

Why is a Manufacturing License Necessary for the Implanted Spinal Cord Stimulator for Bladder Evacuation?

It is mandatory to obtain a manufacturing license before the production of any medical device in India. This process ensures quality control and patient safety by holding manufacturers to strict production standards. Navigating through regulatory compliance plays a critical role in maintaining integrity in the healthcare sector. Furthermore, obtaining the correct manufacturing license safeguards consumers and patients from substandard products, ensuring they receive the health benefits they need.

Steps to Obtain a CDSCO Manufacturing License for the Implanned Spinal Cord Stimulator for Bladder Evacuation

  1. Gather and prepare all necessary documents, including the Device Master File, Quality Management Certificate, Device Details, Site details, etc.
  2. Submit the application and documents to the proper regulatory authority.
  3. Wait for the evaluation of your application.
  4. After approval, pay the required fees and receive your license. To stay up to date with the licensing requirements and process, visit this article.

Frequently Asked Questions (FAQs)

  • Q: What is the risk class of the Implanted Spinal Cord Stimulator for Bladder Evacuation as per Medical Device Rules, 2017?

    • A: The Implanted Spinal Cord Stimulator for Bladder Evacuation is classified as a Class D medical device, which represents the highest risk category.

  • Q: What license is needed to manufacture the Implanted Spinal Cord Stimulator for Bladder Evacuation?

    • A: The required license for manufacturing the Implanted Spinal Cord Stimulator for Bladder Evacuation is the MD9.

  • Q: What is the fee for the MD9 license for the Implanted Spinal Cord Stimulator for Bladder Evacuation?

    • A: The MD9 license fee is Rs. 50,000, with an additional fee of Rs. 1,000 per product.

  • Q: Who will issue the manufacturing license for the Implanted Spinal Cord Stimulation for Bladder Evacuation?

    • A: The CDSCO Headquarters in New Delhi will issue the manufacturing license for Class D devices like the Implanned Spinal Cord Stimulator for Bladder Evacuation.

  • Q: Is repackaging of the Implanted Spinal Cord Stimulator for Bladder Evacuation considered manufacturing?

    • A: 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. The Medical Device Rules have been made under the provisions of the Drug Act only and hence repackaging of the Implanned Spinal Cord Stimulator for Bladder Evacuation is also considered manufacturing requiring a license on MD9.

Conclusion

Navigating through the regulatory landscape of medical device manufacturing can be a complex process. Pharmadocx Consultants are here to simplify this procedure. If you require further assistance or consultation regarding the licensing process for manufacturing high-risk medical devices such as Implanted Spinal Cord Stimulator for Bladder Evacuation, feel free to reach out to Pharmadocx Consultants, or call "+91-7404557227" or email to "[email protected]".

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