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CDSCO Manufacturing License for Microbial medical gas filter

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Introduction

As a guardian of public health, the Central Drugs Standard Control Organization (CDSCO) is a cornerstone of the Indian healthcare sector. Tasked with a broad array of functions such as approving new drugs, conducting clinical trials, controlling import quality, coordinating national regulatory activities, and being the point of contact for international agencies, the CDSCO plays a vital role in ensuring the health and safety of the nation.

In tandem with its roles, the organization rigorously regulates the manufacturing, import, distribution, and sales of medical devices - an indispensable segment of the healthcare industry. Amidst this broad spectrum of medical devices, lies a special tool known as the Microbial medical gas filter. This device serves an essential purpose in preventing patient exposure to harmful microbes during critical procedures such as respiration, anesthesia, or endoscopy.

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What is a Microbial medical gas filter?

A microbial medical gas filter can be described as a sieving device intentionally designed to extract harmful microbes from medical gases. With the aseptic quality of medical gases being crucial in medical procedures, this device plays a pivotal role in ensuring the safety and well-being of patients.

The device is commonly used during respiratory procedures, anesthesia, and endoscopy. In these procedures, sterile medical gases are indispensable for patient safety and recovery, making the gas filter a critical part of the medical team’s toolkit.

The Role of CDSCO in Medical Device Regulation

As the watchdog for the healthcare sector, CDSCO has a storied history and a mission aligned to ensure maintenance of the highest standards of safety, quality, and ethics in the fields of drugs, cosmetics, and medical devices. By harmonizing technical standards and guidelines throughout the country, CDSCO works tirelessly to ensure safety and efficacy of medical devices.

The regulatory framework for medical devices under CDSCO is based on risk-based classification, with clear specifications for manufacturing, importing, registering, and clinical investigation of medical devices.

How to manufacture a Microbial medical gas filter

The manufacturing process of a Microbial medical gas filter must adhere to the guidelines provided by CDSCO. As per its risk classification, the Microbial medical gas filter falls under Class B, thus it requires an MD5 license to manufacture.

Fees for manufacturing license for a Microbial medical gas filter

The fees for an MD5 license, required for manufacturing Class B devices like Microbial medical gas filter, is Rs. 5,000 for the license and Rs. 500 per product. Detailed information about this can be found in this article.

Why is a Manufacturing License Necessary for a Microbial medical gas filter?

A manufacturing license is not just a regulatory compliance. It represents a seal of assurance, standing testament to the quality and safety of any device produced under its purview. Having a license for manufacturing the Microbial medical gas filter certifies that the device meets the stringent standards set by the CDSCO.

This ensures quality, safety, and efficacy of medical devices in the market, thereby protecting consumers and patients from substandard products and adding an additional layer of security in the Indian healthcare sector.

Steps to Obtain a CDSCO Manufacturing License for a Microbial medical gas filter

Obtaining a manufacturing license for a Microbial medical gas filter involves multiple steps. The pre-requisites include requirements such as a Device Master File, Quality Management Certificate, detailed device information, and site details.

The application process starts with the submission of all the required documents and information, after which the application is scrutinized and tested for compliance. Finally, after a rigorous review process, the license is approved.

Navigating through these steps can be challenging, hence professional help is often engaged to ensure smooth and successful completion of the process.

Frequently Asked Questions (FAQs)

Q1. What is risk class of Microbial medical gas filter as per Medical Device Rules, 2017?

The Microbial medical gas filter falls under the Class B risk classification as per Medical Device Rules, 2017.

Q2. What license is needed to manufacture Microbial medical gas filter?

An MD5 license is required for manufacturing Microbial medical gas filter.

Q3. What is fees for MD5 license for Microbial medical gas filter?

The fee for an MD5 license for manufacturing Microbial medical gas filter is Rs. 5,000 for the license and Rs. 500 per product.

Q4. Who will issue manufacturing license for Microbial medical gas filter?

The state FDA will issue the manufacturing license for Class B devices such as the Microbial medical gas filter.

Q5. Is repackaging of Microbial medical gas filter considered manufacturing?

Yes, as per Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing and by further definitions, medical devices are also drugs. Medical Device Rules have been made under the provisions of Drug Act only and hence repackaging of Microbial medical gas filter is also considered manufacturing requiring an MD5 license.

Conclusion

Navigating through the process of obtaining a manufacturing license can be a daunting task. However, at Pharmadocx Consultants, we're here to guide you every step of the way. With our expertise in the CDSCO licensing process, we can assist you in obtaining your manufacturing license with ease. Reach out to us at our website, or call us at +91-7404557227 or email us your queries at [email protected] for professional assistance and consultation.

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