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CDSCO Manufacturing License for Bladder/bowel- evacuation implantable electrical stimulation system

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Introduction

The Central Drugs Standard Control Organization (CDSCO) plays a crucial role in safeguarding the healthcare landscape of our nation. It bears the responsibility of ensuring that medicines, cosmetics, and medical devices circulating within the country's market are safe, effective, and conform to required quality standards. One of the key areas this esteemed regulatory body oversees is the issuance of manufacturing licenses for medical devices.

The healthcare sector, particularly the medical device industry, heavily relies on these licenses. A manufacturing license is a validated assurance that the device in question is produced following stringent guidelines and complies with the quality standards laid by the regulatory agencies. Today, we delve into the details concerning one such device, the 'Bladder/bowel-evacuation Implantable Electrical Stimulation System'.

This medical device holds immense significance in the medical field, aiding individuals who have difficulties in emptying their urinary bladder and/or bowels. For detailed guidance and information, do visit the CDSCO's portal here.

What is a Bladder/bowel-evacuation implantable electrical stimulation system?

A Bladder/bowel-evacuation implantable electrical stimulation system is a medical device designed to aid in emptying the urinary bladder and the bowels. This is achieved through the application of electrical stimuli, typically to the conical end of the spinal cord or the conus medularis. The device offers therapeutic assistance to patients suffering from neurogenic dysfunctions of the lower urinary tract and bowel due to spinal cord injuries, multiple sclerosis, or spina bifida.

The Role of CDSCO in Medical Device Regulation

Since its inception, the CDSCO has been dedicated to the mission of protecting and promoting public health in India. One of its focal areas of operation is the regulation of medical devices, ensuring their safety and efficacy. The regulatory framework put forth by CDSCO for medical devices is robust and comprehensive, working towards mitigating risks associated with the use of these devices.

How to manufacture a Bladder/bowel-evacuation Implanted Electrical Stimulation System?

The manufacturing of a Bladder/bowel-evacuation implantable electrical stimulation system delves into the domain of advanced medical technology. Being a Class D device, it falls into the highest risk category and is subject to stringent regulatory scrutiny.

Fees for manufacturing license for the Bladder/bowel-evacuation implantable electrical stimulation system.

For obtaining a manufacturing license for a Class D medical device, an MD9 license is needed. The fee for an MD9 license is Rs. 50,000, plus Rs. 1,000 per product. Click for further details.

Why is a Manufacturing License Necessary for the Bladder/bowel-evacuation implantable electrical stimulation system?

Given the critical role that a Bladder/bowel-evacuation implantable electrical stimulation system plays in patient care, obtaining a manufacturing license is mandatory. This legally-binding requirement ensures that the device's production meets the requisite quality standards and follows the stipulations laid down by the regulatory authorities. Regulatory compliance is essential to warrant safety, protect patients from subpar products, and uphold the integrity of the healthcare sector.

Steps to Obtain a CDSCO Manufacturing License for the Bladder/bowel-evacuation implantable electrical stimulation system

  1. Procure the necessary documents, including a Device Master File, Quality Management Certificate, Device Details, Site details etc.
  2. Submit the application for the license.
  3. Wait for the processing period.
  4. Get the approval for the license.

Documentation and procedural challenges can be overcome with proper planning and expert guidance.

Frequently Asked Questions (FAQs)

  1. What is the risk class of Bladder/bowel-evacuation implantable electrical stimulation system as per Medical Device Rules, 2017?

The risk class of Bladder/bowel-evacuation implantable electrical stimulation system is Class "D".

  1. What license is needed to manufacture a Bladder/bowel-evacuation implantable electrical stimulation system?

An MD9 license is required to manufacture a Bladder/bowel-evacuation implantable electrical stimulation system.

  1. What is the fee for the MD9 license for a Bladder/bowel-evacuation implantable electrical stimulation system?

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

  1. Who will issue the manufacturing license for a Bladder/bowel-evacuation implantable electrical stimulation system?

The manufacturing license for a Bladder/bowel-evacuation implantable electrical stimulation system will be issued by the CDSCO HQ in New Delhi.

  1. Is repackaging of a Bladder/bowel-evacuation implantable electrical stimulation system considered manufacturing?

Yes, as per the Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is deemed as manufacturing. Similarly, since medical devices are also categorized as drugs, repackaging of a Bladder/bowel-evacuation implantable electrical stimulation system necessitates an MD9 license.

Conclusion

Manufacturing a medical device, especially one of high significance like a Bladder/bowel-evacuation implantable electrical stimulation system, demands thorough knowledge and a deep understanding of the regulatory landscape. We, at Pharmadocx Consultants, strive to assist you in navigating this complex process seamlessly. You may visit our website here or call us on +91-7404557227 or email us at [email protected] for detailed consultation or assistance regarding the licensing process.

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