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CDSCO Manufacturing License for Tibial nerve percutaneous incontinence- control electrical stimulation system

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Introduction

The Central Drugs Standard Control Organization (CDSCO) is a premier national regulatory body under the governance of the Ministry of Health & Family Welfare, India. Its core responsibility and function are to develop and implement scientific and regulatory guidelines concerning the safety, efficacy, and quality of pharmaceuticals, medical devices, diagnostics, and cosmetics manufactured and imported into India.

Manufacturing licenses hold immense importance in the medical device industry. They act as a testimony that the device has undergone stringent checks and balances and meets the industry-defined quality and performance standards. This eliminates the risk of substandard products hitting the market and safeguards the health and well-being of the consumers.

One such remarkable device is the Tibial nerve percutaneous incontinence- control electrical stimulation system that has profoundly revolutionized the treatment approach for urinary and/or faecal incontinence. This blog will start with a comprehensive overview of this medical device and proceed to detail out the steps involved in acquiring a manufacturing license from CDSCO.

What is Tibial nerve percutaneous incontinence- control electrical stimulation system?

The Tibial nerve percutaneous incontinence- control electrical stimulation system is a revolutionary medical device specially designed to treat urinary and faecal incontinence. The fundamental principle of this device revolves around percutaneous tibial nerve stimulation (PTNS), which uses mild electrical impulses to stimulate the Tibial nerve.

The device is popularly used for non-surgical management of incontinence. The intact pathway between the Tibial nerve in the leg and the nerves involved in bladder control is exploited for this treatment, leading to a significant reduction in incontinence.

The Role of CDSCO in Medical Device Regulation

CDSCO has played a pivotal role in laying down a comprehensive regulatory framework for Medical Devices in India, with the goal of ensuring that the highest standards of safety, efficacy, and quality are maintained. This methodically laid out framework encompasses everything from the basic prerequisites for a manufacturing license, the quality checks to be adhered to during the manufacturing process, to post-manufacturing audits and checks.

How to manufacture Tibial nerve percutaneous incontinence- control electrical stimulation system.

The manufacturing process of the Tibial nerve percutaneous incontinence-control electrical stimulation system begins with an extensive understanding of the device design and its intended use. Every part and component of the device are carefully chosen and assembled to ensure the highest levels of safety and functionality. Strict regulations are followed to meet the necessary manufacturing and quality control standards.

Fees for manufacturing license for Tibial nerve percutaneous incontinence- control electrical stimulation system

As the Tibial nerve percutaneous incontinence- control electrical stimulation system falls under risk class D, the required license would be MD9. The fees for MD9 is Rs. 50,000 for the license and Rs. 1,000 per product. More information can be found here.

Why is a Manufacturing License Necessary for Tibial nerve percutaneous incontinence- control electrical stimulation system?

Acquiring a manufacturing license from a reputed organization like CDSCO greatly enhances the credibility of the products. It assures the consumers of the quality and safety of the device, fosters trust and confidence in the use of the product, and protects consumers from possible risks.

Steps to Obtain a CDSCO Manufacturing License for Tibial nerve percutaneous incontinence- control electrical stimulation system

Obtaining a manufacturing license for a medical device involves a series of steps:

  1. Submit the Device Master File and other necessary documents.
  2. Obtain a Quality Management Certificate.
  3. Provide full details about the device and the production site.
  4. Wait for the evaluation and approval from the authorities.

Frequently Asked Questions (FAQs)

1. What is the risk class of the Tibial nerve percutaneous incontinence- control electrical stimulation system as per Medical Device Rules, 2017?

The system is classified under risk class D.

2. What license is needed to manufacture the Tibial nerve percutaneous incontinence- control electrical stimulation system?

MD9 is the required license to manufacture this device.

3. What is the fee for an MD9 license for the Tibial nerve percutaneous incontinence- control electrical stimulation system?

The fee for an MD9 license is Rs. 50,000 and Rs. 1,000 per product.

4. Who will issue the manufacturing license for the Tibial nerve percutaneous incontinence- control electrical stimulation system?

The CDSCO HQ in New Delhi will issue the license.

5. Is repackaging of the Tibial nerve percutaneous incontinence- control electrical stimulation system considered manufacturing? Yes, repackaging of this system is considered manufacturing, requiring a license on MD9.

Conclusion

Acquiring a manufacturing license for a medical device can be an intricate process. It needs a deep understanding of regulatory norms, accurate documentation, and adherence to timelines. If you require any assistance with the licensing process, reach out to Pharmadocx Consultants at https://www.pharmadocx.com, calling at +91-7404557227, or emailing at [email protected]. They are always available to support your licensing needs and queries.

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