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CDSCO Manufacturing License for Extramuscular diaphragm/phreni c nerve electrical stimulation system

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Introduction

The Central Drugs Standard Control Organization (CDSCO) is the primary regulatory body for pharmaceuticals and medical devices in India, operating under the Ministry of Health and Family Welfare. Playing a strategic role in maintaining the standards of medical devices and ensuring their quality, safety, and efficacy, CDSCO’s overarching responsibility is to protect and promote public health.

In the medical device industry, manufacturing licenses play a crucial role, assuring consumers and healthcare providers of the quality and safety of the devices. Today, we delve into the in-depth significance of the Extramuscular Diaphragm/Phrenic Nerve Electrical Stimulation system and the importance of its CDSCO manufacturing license. The CDSCO's portal could be accessed here for more details.

What is an Extramuscular Diaphragm/Phrenic Nerve Electrical Stimulation System?

This technologically advanced and specific medical device is designed to provide ventilatory support to patients suffering from neuromuscular dysfunction of the diaphragm. It achieves this through a rhythmic contraction of the diaphragm, stimulated by electrodaily induced current pulses on the phrenic nerve, aiding the patient in drawing breath naturally and seamlessly.

This system plays a crucial role in maintaining comfortable and ordinary breathing in patients suffering from related disorders, highlighting its essential role in the treatment and management of such conditions.

The Role of CDSCO in Medical Device Regulation

Since its inception, CDSCO has been mandated with ensuring the safety, efficacy, and quality of medical devices available in India, through a robust regulatory framework dedicated to medical devices. With a mission centered around safeguarding public health, it formulates standards, guidelines, and regulations applicable to the manufacturing process of medical devices, including the Extramuscular Diaphragm/Phrenic Nerve Electrical Stimulation System.

How to Manufacture an Extramuscular Diaphragm/Phrenic Nerve Electrical Stimulation System

The manufacturer must adhere to specific standards and regulations to ensure the safety, efficacy, and quality of the product. This involves various specialized stages, including procuring high-quality components, state-of-the-art manufacturing techniques, stringent testing procedures, and quality assurance measures.

Fees for Manufacturing License for Extramuscular Diaphragm/Phrenic Nerve Electrical Stimulation System

Being a Class D medical device, it requires an MD9 license for manufacturing. The fees applicable for this license is Rs. 50,000, with an additional fee of Rs. 1,000 per product.

Why is a Manufacturing License Necessary for an Extramuscular Diaphragm/Phrenic Nerve Electrical Stimulation System?

Obtaining a license to manufacture a medical device is a regulatory requisite, aimed at ensuring the quality and safety in medical device production. Regulatory compliance plays a pivotal role in safekeeping consumers and patients against substandard products, promoting trust and assurance in the healthcare industry.

Steps to Obtain a CDSCO Manufacturing License for Extramuscular Diaphragm/Phrenic Nerve Electrical Stimulation System

Acquiring a manufacturing license entails a specific process and documentation, including:

  1. Device Master File
  2. Quality Management Certificate
  3. Device Details
  4. Site details

After preparing the required documentation, the application submission process begins, which culminates in the approval stage. This journey is laden with challenges that can be effectively managed with proper guidance and preparedness.

Please refer to our comprehensive guide for detailed information on MD9 license.

Frequently Asked Questions (FAQs)

Q.1. What is the risk class of Extramuscular Diaphragm/Phrenic Nerve Electrical Stimulation System as per Medical Device Rules, 2017?

A.1. The Extramuscular Diaphragm/Phrenic Nerve Electrical Stimulation System falls under the Risk Class D as per Medical Device Rules, 2017.

Q.2. What license is needed to manufacture Extramuscular Diaphragm/Phrenic Nerve Electrical Stimulation System?

A.2. To manufacture this medical device, an MD9 license is required.

Q.3. What is the fee for an MD9 license for Extramuscular Diaphragm/Phrenic Nerve Electrical Stimulation System?

A.3. The fee for an MD9 license is Rs. 50,000 and an additional Rs. 1,000 per product.

Q.4. Who will issue the manufacturing license for Extramuscular Diaphragm/Phrenic Nerve Electrical Stimulation System?

A.4. The CDSCO Headquarters in New Delhi will issue the license for Class D devices.

Q.5. Is repackaging of Extramuscular Diaphragm/Phrenic Nerve Electrical Stimulation System considered manufacturing?

A.5. Yes, as per the Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is deemed to be manufacturing. Further definitions consider medical devices as drugs, requiring a license on MD9.

Conclusion

Navigating through the regulatory landscape and complying with the rules and regulations can be a rigorous task. Our seasoned consultants at Pharmadocx Consultants can assist you. For further consultation, call "+91-7404557227" or email at [email protected]. We're here to help you streamline and simplify the process of obtaining the license you need, ensuring compliance, and maintaining the highest standards of safety and efficacy in your medical devices.

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