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CDSCO Manufacturing License for High-frequency ventilator

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Introduction

Central Drugs Standard Control Organization (CDSCO) is India's premier national regulatory body. Its primary responsibility consists of securing public health by ensuring the quality, safety, and effectiveness of drugs, cosmetics, and medical devices. Medical device industry is an area that constantly evolves with time due to the fast-paced nature of technological advancement. In this ever changing scenario, a role of a regulatory body becomes increasingly critical to ensure that every device reaching the market is safe and performing the intended functions properly.

We will focus on High-frequency ventilator, a medical device of immense importance in the healthcare sector. You can visit CDSCO's portal for more details about the regulatory aspects.

What is a High-Frequency Ventilator?

A High-frequency ventilator is a specialized type of ventilator that provides respiratory support to patients who have compromised lung function. This device delivers small tidal volumes at a high frequency, improving ventilation and oxygenation while reducing ventilator-induced lung injury.

This device plays a crucial role in critical care situations, where it aids in the management of ventilation in patients who require respiratory support. It is widely used in ICUs, neonatal units, and during anesthesiological procedures.

The Role of CDSCO in Medical Device Regulation

CDSCO is charged with the responsibility of establishing standards and regulating the manufacture, sale, and distribution of medical devices in India. Its mission is to continually enhance public health by enforcing high standards of safety, quality, and performance of medical devices.

Over the years, CDSCO has developed a robust regulatory framework consisting of directives and guidelines for regulating various aspects of the medical device industry, including manufacture, import, sale and clinical investigation of medical devices.

How to Manufacture a High-Frequency Ventilator

For manufacturing high-frequency ventilators which come under Class C, a MD9 license is required as per the directives of CDSCO. This procedure ensures the standardization of the manufacturing process, ensuring the production of high-quality and safe products.

Fees for Manufacturing License for High-Frequency Ventilator

Class C devices require an MD9 license that costs Rs. 50,000, and an additional Rs. 1,000 per product.

Why is a Manufacturing License Necessary for a High-Frequency Ventilator?

Regulatory compliance in the medical device industry is not just a legal obligation, but an ethical and social responsibility too. A manufacturing license acts as proof of adherence to the guidelines and standards prescribed by the CDSCO. It ensures high-quality and safety of the produced medical device. The license protects public health by preventing the market proliferation of substandard and potentially hazardous products.

Steps to Obtain a CDSCO Manufacturing License for a High-Frequency Ventilator

First, the necessary documentation such as the Device Master File, Quality Management Certificate, Device Details, Site details etc., must be assembled and organized in compliance with the guidelines.

Next, the application is submitted to the relevant authority. This initiates the review process where the complete application package is evaluated for compliance with CDSCO guidelines.

Once the application has been assessed and deemed satisfactory, the license is given approval.

Although, certain challenges may arise during this process, they can be overcome by diligent adherence to regulatory requirements and expert guidance.

Frequently Asked Questions (FAQs)

Q1. What is risk class of High-Frequency Ventilator as per Medical Device Rules, 2017?

Ans. The risk class of High-Frequency Ventilator is ‘C’.

Q2. What license is needed to manufacture High-Frequency Ventilator?

Ans. An MD9 license is required to manufacture High-Frequency Ventilator.

Q3. What is the fee for MD9 license for High-Frequency Ventilator?

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

Q4. Who will issue manufacturing license for High-Frequency Ventilator?

Ans. For High-Frequency Ventilator, which falls under Class C, CDSCO HQ in New Delhi will issue the license.

Q5. Is repackaging of High-Frequency Ventilator considered manufacturing?

Ans. Yes, as per Drugs and Cosmetics Act's definition of manufacturing, repackaging of medical devices is considered manufacturing. Hence, repackaging of High-Frequency Ventilator is also considered manufacturing requiring MD9 license.

Conclusion

Navigating the intricacies of the licensing process can be a daunting task. Seeking professional assistance can ensure a smoother process and help you overcome any potential hurdles. At Pharmadocx Consultants, we take pride in helping our clients through every step of the licensing process with our experience, knowledge, and dedication.

Feel free to reach out to us for any consultation or assistance regarding the licensing process. Visit our website at Pharmadocx Consultants, or call us at +91-7404557227 or send an email to [email protected].

For more details about the MD9 license and its procedure link, refer here.

Remember, a right regulatory partner can make a significant difference for your business success. We're here to make that difference.

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