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CDSCO Manufacturing License for Negative-pressure ventilator

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Introduction

The Central Drugs Standard Control Organization (CDSCO) is the pinnacle body of India, associated with the regulation of health and family welfare. It plays a pivotal role in safeguarding and promoting public health by ensuring the quality, safety, and efficacy of drugs, cosmetics, and medical devices. The strict regulatory control is exercised over the manufacture, sale, and distribution of these devices, significantly making them'manufacturing licenses' critical for the medical device industry.

This blog post focuses on the Negative-pressure Ventilator, a Class C medical device. This device is an important part of medical care, particularly in anesthesia. To know more about CDSCO, its regulations, and the licensing process, you can visit their official portal here.

What is Negative-pressure Ventilator?

A Negative-pressure Ventilator is a special device used in medical procedures associated with the respiratory system. The intended use of this device is to assist or control alveolar respiration— it works by exerting a negative pressure on the external surface of the chest wall. This expands the chest and helps move air into the lungs, notably used during anesthesia procedures.

The Role of CDSCO in Medical Device Regulation

The CDSCO, under the Ministry of Health, has a vast regulatory control system governing drugs, vaccines, medical devices, and more. Its primary mission is to protect citizens by ensuring that health products meet high safety, efficacy, and quality standards. For medical devices such as a Negative-Pressure Ventilator, the CDSCO has a stringent regulatory framework that ensures manufacturing and distribution adhere strictly to set standards.

How to manufacture Negative-pressure Ventilator?

Manufacturing a Negative-pressure Ventilator needs adherence to CDSCO guidelines corresponding to the specific device's risk class. The Negative-Pressure Ventilator falls under the Class C category, implying a high risk. Therefore, manufacturers must be cautious about maintaining high standards and quality controls.

Fees for Manufacturing License for Negative-pressure Ventilator

The fee structure for obtaining a Manufacturing license for a Class C medical device like a Negative-Pressure Ventilator entails an MD9 license. This requires a fee of Rs. 50,000 for the license and Rs. 1,000 per product.

Why is a Manufacturing License Necessary for Negative-pressure Ventilator?

Obtaining a manufacturing license for such medical devices is mandatory. These licenses serve to ensure quality control and assure the safety of medical device production. They are significant for regulatory compliance in the healthcare sector, aimed at protecting customers and patients from low-grade or substandard products.

Steps to Obtain a CDSCO Manufacturing License for Negative-pressure Ventilator

Manufacturing of Negative-pressure Ventilator involves these essential steps:

  1. Collection of necessary documents like Device Master File, Quality Management Certificate, Device Details, Site details, etc.
  2. Filing a precise application and submitting to the respective authority
  3. Detailed review process by the authority
  4. Unlocking the final approval after strict scrutiny of the application and the provided documents

Frequently Asked Questions (FAQs)

Q1. What is the risk class of Negative-pressure Ventilator as per Medical Device Rules, 2017?

The Negative-pressure Ventilator is classified as a Class C medical device as per Medical Device Rules, 2017.

Q2. What license is needed to manufacture Negative-pressure Ventilator?

An MD9 license is required to manufacture a Negative-pressure Ventilator.

Q3. What is the fee for the MD9 license for Negative-pressure Ventilator?

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

Q4. Who will issue a manufacturing license for Negative-pressure Ventilator?

The CDSCO Headquarters in New Delhi issues the manufacturing license for a Negative-pressure Ventilator.

Q5. Is repackaging of Negative-pressure Ventilator considered manufacturing?

Yes, as per the Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing. The repackaging of Negative-pressure Ventilator is also considered manufacturing requiring an MD9 license.

Conclusion

Acquiring a CDSCO Manufacturing License for medical devices can be a complex process. It's essential to ensure regulatory compliance and safeguard patients' health.

For consultation or assistance in licensing, reach out to the Pharmadocx Consultants, where experts can guide you through the entire procedure. Click here to access our website, call "+91-7404557227", or you can even email us directly at "[email protected]".

In-depth info about the MD9 license can be accessed in the following article - CDSCO MD9 Manufacturing License Consultant for Medical Devices in India

All the best for your journey on manufacturing Negative-pressure Ventilators and making a positive difference in the healthcare sector. Health is the true wealth, indeed!

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