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CDSCO Manufacturing License for Implantable spinal cord electrical stimulation system programmer

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Introduction

The Central Drugs Standard Control Organization (CDSCO) plays a pivotal role in the health care sector of India, ensuring the safety, efficacy and quality of drugs, cosmetics, and medical devices. One of the key responsibilities of CDSCO is the regulation of medical devices, which includes the issuance of manufacturing licenses. These licenses are critical in maintaining the high standards and quality control measures in the medical device industry.

In the spectrum of medical devices, the Implantable Spinal Cord Electrical Stimulation System Programmer takes a significant position. Such devices are designed to telemetrically alter one or more of the operating parameters (the programs) of an implanted spinal cord electrical stimulation system pulse generator, affirming their medical importance. More details about the device and its manufacturing license can be found on the CDSCO's portal.

What is Implantable Spinal Cord Electrical Stimulation System Programmer?

The Implantable Spinal Cord Electrical Stimulation System Programmer is a medical device designed to remotely change the operating parameters of an implanted spinal cord electrical stimulation system pulse generator. The device plays an integral role in managing chronic pain conditions by enabling alterations to the stimulation intensity generated by the pulse generator.

Common procedures involving this device include the management of failed back surgery syndrome, complex regional pain syndrome and other chronic pain conditions. Its programming features facilitate patient-specific treatment settings, improving the overall patient experience.

The Role of CDSCO in Medical Device Regulation

CDSCO, under the Ministry of Health & Family Welfare, Government of India, regulates the safety and efficacy of medical devices in India. Their mission is to ensure the accessibility of safe, effective, and high-quality medical devices in the Indian market.

An important part of their regulatory framework is the classification of medical devices into four risk classes - A, B, C, and D. The Implantable Spinal Cord Electrical Stimulation System Programmer is classified under risk class C, for which an MD9 license is required to manufacture.

How to manufacture Implantable Spinal Cord Electrical Stimulation System Programmer

As per the classification, an MD9 license is required to manufacture Implantable Spinal Cord Electrical Stimulation System Programmers, this involves stringent guidelines to ensure safety, ergonomics, and efficacy.

Fees for manufacturing license for Implantable Spinal Cord Electrical Stimulation System Programmer

For devices falling under the risk class C, a license fee of Rs. 50,000 for the license and an additional Rs. 1,000 per product is required.

Why is a Manufacturing License Necessary for Implantable Spinal Cord Electrical Stimulation System Programmer?

Manufacturing licenses are a mandatory regulatory requirement for the production of medical devices. It ensures the adherence to quality control measures during the manufacturing process, thereby enhancing the safety and efficacy of medical devices. The CDSCO's stringent regulations aids in protecting patients and consumers from substandard products.

Regulatory compliance holds immense significance in the healthcare sector as it acts as a testament to the manufacturer's commitment to quality and safety.

Steps to Obtain a CDSCO Manufacturing License for Implantable Spinal Cord Electrical Stimulation System Programmer

  1. Arrangement of necessary pre-requisites like Device Master File, Quality Management Certificate, Device Details, Site details, etc.
  2. Submission of application to CDSCO with the necessary documentation.
  3. Approval process following the requirement verification.
  4. Obtaining the license post-approval, adhering to the compliance measures.

However, the process might involve certain challenges which can be tackled effectively with proper planning and guidance, this article provides an in-depth guide on the same.

Frequently Asked Questions (FAQs)

  1. Q: What is risk class of Implantable Spinal Cord Electrical Stimulation System Programmer as per Medical Device Rules, 2017?

    A: The Implantable Spinal Cord Electrical Stimulation System Programmer falls under risk class C as per Medical Device Rules, 2017.

  2. Q: What license is needed to manufacture Implantable Spinal Cord Electrical Stimulation System Programmer?

    A: An MD9 license is required to manufacture the Implantable Spinal Cord Electrical Stimulation System Programmer.

  3. Q: What is the fee for an MD9 license for the Implantable Spinal Cord Electrical Stimulation System Programmer?

    A: The fee for an MD9 license for this device is Rs. 50,000 for the license and Rs. 1,000 per product.

  4. Q: Who will issue the manufacturing license for the Implantable Spinal Cord Electrical Stimulation System Programmer?

    A: For class C devices, CDSCO HQ in New Delhi will issue the license.

  5. Q: Is the repackaging of the Implantable Spinal Cord Electrical Stimulation System Programmer considered manufacturing?

    A: Yes, according to the Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs, including medical devices, requires a license. Specifically, repackaging of the Implantable Spinal Cord Electrical Stimulation System Programmer requires an MD9 license.

Conclusion

The process of obtaining a CDSCO manufacturing license can be an intricate process, with numerous compliance and regulatory requirements. However, professional consultation can guide you through this process, making it a lot more simplistic and straightforward.

For expert assistance, feel free to reach out to Pharmadocx Consultants via their website, call them on +91-7404557227, or drop them an email at [email protected]. Let their expertise guide you through the complicated labyrinth of the licensing process to a successful end.

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