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CDSCO Manufacturing License for Ethylene oxide gas sterilizer.

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Introduction

The Central Drugs Standard Control Organization (CDSCO) is India's premier regulatory body overseeing the safety, effectiveness, and quality control of drugs, cosmetics, diagnostics, and devices. CDSCO ensures that the drugs and devices accessible to the Indian public are safe and effective. Crucial to CDSCO's responsibility is the issuance of manufacturing licenses, particularly in the medical device industry.

This blog post will cover the Ethylene oxide gas sterilizer, a significant medical device for healthcare providers. We will explore its intended use, the associated risk class, the necessary licenses for manufacturing, and the steps to obtain these licenses from CDSCO. CDSCO's portal provides comprehensive information about CDSCO's activities and functions.

What is an Ethylene Oxide Gas Sterilizer?

An Ethylene oxide gas sterilizer is a medical device that uses ethylene oxide gas to sterilize medical devices. The sterilizer utilizes ethylene oxide's bactericidal, fungicidal, and sporicidal properties to ensure that medical devices are safe for use.

Its common usage includes the sterilization of medical and surgical devices that cannot be sterilized by high-temperature methods such as steam.

The Role of CDSCO in Medical Device Regulation

The CDSCO has a pivotal role in regulating medical devices in India. The vision of the organization is to safeguard and enhance public health by assuring the safety, efficacy, and quality of medical devices.

The CDSCO regulatory framework for medical devices is designed to regulate and supervise the medical device industry, ensuring the safety and efficacy of devices distributed within the country.

How to manufacture an Ethylene Oxide Gas Sterilizer

The manufacturing process of an Ethylene Oxide Gas Sterilizer involves technical and mechanical expertise. Manufacturers must adhere to strict quality and safety guidelines to ensure the device's effectiveness.

Fees for manufacturing license for Ethylene Oxide Gas Sterilizer

Since the Ethylene Oxide Gas Sterilizer falls under the category of a Class C risk device, the license required for manufacturing is MD9. The fee for an MD9 license is Rs. 50,000, and an additional Rs. 1,000 is charged per product.

Why is a Manufacturing License Necessary for an Ethylene Oxide Gas Sterilizer

Obtaining a manufacturing license is a mandated procedure for any manufacturer. It ensures quality and safety standards are met during production. Regulatory compliance plays a significant role in the healthcare industry, providing assurance for consumers and patients against substandard products.

Steps to Obtain a CDSCO Manufacturing License for Ethylene Oxide Gas Sterilizer

Manufacturers must adhere to specific pre-requisites before applying for the CDSCO manufacturing license. These prerequisites include the Device Master File, Quality Management Certificate, device details, and site details.

The application process for a CDSCO license encompasses several stages, from submission and review to final approval. Although the process can pose several challenges, being prepared and having adequate knowledge of the procedure can significantly expedite the approval process.

Frequently Asked Questions (FAQs)

Q1. What is the risk class of Ethylene Oxide Gas Sterilizer as per Medical Device Rules, 2017?

Class C

Q2. What license is needed to manufacture Ethylene Oxide Gas Sterilizer?

MD9 license is required for manufacturing.

Q3. What is the fees for MD9 license for Ethylene Oxide Gas Sterilizer?

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

Q4. Who will issue the manufacturing license for Ethylene Oxide Gas Sterilizer?

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

Q5. Is repackaging of Ethylene Oxide Gas Sterilizer 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 the Drug Act only and hence repackaging of Ethylene Oxide Gas Sterilizer is also considered manufacturing requiring a license on MD9

Conclusion

If you need consultation or assistance regarding the licensing process, please feel free to reach out to Pharmadocx Consultants at their website "Pharmadocx Consultants", call them at "+91-7404557227", or email them at "[email protected]".

You can learn more about the MD9 license in this article here.

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