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CDSCO Manufacturing License for Transvenous phrenic nerve electrical stimulation control unit

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Introduction

The Central Drugs Standard Control Organization (CDSCO) plays a vital role in the Indian healthcare sector, regulating drugs, cosmetics, and medical devices to ensure safety and efficacy. In the medical device industry, acquiring manufacturing licenses is a crucial step in maintaining quality control and compliance.

Today, we explore the pivotal role of the CDSCO in regulating the manufacturing of the Transvenous Phrenic Nerve Electrical Stimulation Control Unit, an essential medical device with significant clinical value. This write-up will guide you through the specific regulations, manufacturing licenses and fees related to this device. For more information, visit the CDSCO's portal here.

What is a Transvenous Phrenic Nerve Electrical Stimulation Control Unit?

A Transvenous Phrenic Nerve Electrical Stimulation Control Unit, as its name suggests, is an electronic device designed to control and deliver electrical stimulation to the phrenic nerve via a transvenous electrode. The stimulation of the phrenic nerve induces the contraction of the diaphragm, which aids in mechanical ventilation. This mechanism can assist in earlier ventilation weaning during the recovery process.

The Role of CDSCO in Medical Device Regulation

Regulating medical devices falls within the purview of CDSCO. It was established with the primary mission to ensure the safety, efficacy, and quality of drugs, cosmetics, and medical devices in India. The regulatory framework for medical devices, including the Transvenous Phrenic Nerve Electrical Stimulation Control Unit, is robust and has evolved over the years in alignment with global standards.

How to Manufacture a Transvenous Phrenic Nerve Electrical Stimulation Control Unit

Detailed manufacturing guidelines will be provided upon acquiring the necessary manufacturing license. Please refer to CDSCO's directives for more information.

Fees for Manufacturing License for a Transvenous Phrenic Nerve Electrical Stimulation Control Unit

Since this device falls under Class D medical devices, an MD9 license is required for its manufacturing. The fee for the MD9 license is Rs. 50,000, and there is an additional charge of Rs. 1,000 per product.

Why is a Manufacturing License Necessary for a Transvenous Phrenic Nerve Electrical Stimulation Control Unit?

The manufacturing license is a mandate for the production of any medical device. Apart from the obvious legal compliance reasons, it ensures the quality and safety aspects in the production, thereby safeguarding the patients from substandard products. In all, it demonstrates the manufacturer's commitment to health and safety standards.

Steps to Obtain a CDSCO Manufacturing License for a Transvenous Phrenic Nerve Electrical Stimulation Control Unit

Obtaining the manufacturing license comprises several steps

  1. Documentation: Device Master File, Quality Management Certificate, Device Details, Site details, etc. need to be in order.
  2. Submission of application along with the supportive documents.
  3. Review of application and correction, if any.
  4. Approval of the application.

Challenges may arise in the process; however, expert consultation can help circumvent these hurdles. For more details, consult this article on the MD9 manufacturing license.

Frequently Asked Questions (FAQs)

Q1. What is the risk class of the Transvenous Phrenic Nerve Electrical Stimulation Control Unit as per Medical Device Rules, 2017?

Class D.

Q2. What license is needed to manufacture Transvenous Phrenic Nerve Electrical Stimulation Control Unit?

MD9 license is needed for manufacturing this device.

Q3. What is the fee for an MD9 license for a Transvenous Phrenic Nerve Electrical Stimulation Control Unit?

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

Q4. Who will issue the manufacturing license for Transvenous Phrenic Nerve Electrical Stimulation Control Unit?

The CDSCO HQ in New Delhi will issue the license for Class D devices.

Q5. Is repackaging of Transvenous Phrenic Nerve Electrical Stimulation Control Unit considered manufacturing?

Yes, repackaging of Transvenous Phrenic Nerve Electrical Stimulation Control Unit is considered manufacturing and needs an MD9 license.

Conclusion

The licensing process, although challenging, is an essential part of ensuring the safety and effectiveness of medical devices. Reach out to Pharmadocx Consultants for advice or assistance regarding the licensing process. You can also call us at +91-7404557227 or email [email protected] with your queries. We stand ready to assist you in navigating this intricate process and help ensure that your medical device reaches the market with the requisite approval in place.

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