A license to Manufacture or Import ETO Sterilizers has been made compulsory by the CDSCO. For Mnaufacutirng ETO a license on MD 9 is required and for Importing ETO Sterilizers a License on Form MD 15 is required from the CDSCO.

The CDSCO with its notification date of 16 March 2022, under the heading “General Hospital/Orthopaedic” wide file no. 29/Misc./03/2020-DC (193) Part III has classified ETO ( Ethylene Oxide Steriliser) as a moderately high-risk class C Medical Device. For Manufacturing or Import of Ethylene Oxide Sterilizers, A license on Form MD 9 and MD 15 respectively is required. In this article, you will find complete information regarding various approvals and steps which need to be taken in order to manufacture and Import ETO Sterilizers.

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What is the Class of ETO (Ethylene Oxide Steriliser) as per CDSCO

The CDSCO with its notification date of 16 March 2022, under the heading “General Hospital/Orthopaedic” wide file no. 29/Misc./03/2020-DC (193) Part III has classified ETO ( Ethylene Oxide Steriliser) as a moderately high-risk class C Medical Device

The above notification can be downloaded from our Website’s Download section

Description of ETO (Ethylene Oxide Steriliser) as per CDSCO

Sr No. in the List	Name of the Medical Device	Description	Risk Class
43	Ethylene oxide gas sterilizer	Intended for use by a health care provider that uses ethylene oxide (ETO) to sterilize medical devices	Class C

Ethylene Oxide Gas (ETO) Sterilizer is Class C product as per CDSCO List on Serial Number 43 for the description “Intended for use by a health care provider that uses ethylene oxide (ETO) to sterilize medical devices”

Description of ETO Sterilizer as per CDSCO

As per CDSCO Notification. ETO Sterilizer is defined as a device having intended use “Intended for use by a health care provider that uses ethylene oxide (ETO) to sterilize medical devices”.

As per the above notification, ETO Sterilizer is Classified as a Risk Class C Device.

What is Ethylene Oxide (ETO) Sterilizer?

ETO sterilizer, also known as Ethylene Oxide sterilizer, is a type of sterilization equipment used to sterilize medical devices, pharmaceutical products, and other sensitive materials that cannot be sterilized by traditional heat-based methods.

ETO sterilization works by exposing the material to a mixture of ethylene oxide gas and other gases, which can penetrate through the material and kill microorganisms such as bacteria, viruses, and spores. The process is carried out in a sealed chamber where the material is subjected to a carefully controlled combination of temperature, pressure, and humidity.

ETO sterilizers are widely used in the healthcare industry for sterilizing medical devices, such as surgical instruments, catheters, and implantable devices. They are also used for sterilizing pharmaceutical products, such as drugs and vaccines

How are ETO Sterilizers made?

The manufacturing procedure for ETO sterilizers typically involves several stages, including design, fabrication, assembly, testing, and validation. Here is an overview of each stage:

1. Design: The design phase involves conceptualizing the sterilizer, determining its size, capacity, and features, and developing engineering drawings and specifications. The design phase also includes selecting the appropriate materials, components, and control systems to ensure the sterilizer meets regulatory requirements and industry standards.
2. Fabrication: Once the design is finalized, the fabrication phase involves cutting, bending, welding, and machining the materials to create the sterilizer components. This process may involve the use of specialized equipment such as laser cutters, CNC machines, and welding machines.
3. Assembly: The assembly phase involves assembling the various components of the sterilizer, such as the chamber, door, valves, and control panel. This is typically done in a cleanroom environment to ensure that the sterilizer remains sterile during the assembly process.
4. Testing: Once the sterilizer is assembled, it undergoes a series of tests to ensure that it meets the required specifications and regulatory standards. This includes tests for leakages, pressure, temperature, and humidity.
5. Validation: The final stage of the manufacturing process involves validating the sterilizer to ensure that it is capable of consistently producing sterile products. This involves running validation cycles using biological indicators, which are placed inside the sterilizer to measure the effectiveness of the sterilization process.

What are the requirements to Manufacture ETO (Ethylene Oxide) Sterilizer

In order to manufacture ETO (Ethylene Oxide) Sterilizers, a License on Form MD 9 is Required from the CDSCO. This license is issued from the Head Quarters in Delhi. Application for this license is made on MD 7 to the CDSCO. After the Scrutiny of the documents by the Zonal CDSCO Office, an audit is conducted by a team of Medical Device Officers from CDSCO.

The list of Documents Required to Obtain an MD9 License from CDSCO for ETO Sterilizers can Be downloaded from our website’s Download Section. You can also watch videos on the topic on our youtube channel. You can also contact us to guide you in the process for Obtaining the license. More information regarding CDSCO license can be obtained by clicking here.

A minimum area of Around 1500 Square feet is required to Manufacture ETO Sterilizers. No Objection Certificate from The Pollution Control Board and Fire Office has to be procured.

What are the minimum qualifications for Manufacturing ETO Sterilizers?

As per CDSCO following are the Minimum qualification and experience requirements to manufacture ETO Sterilizers. You will require 2 People with the below qualifications.

Sr. No.	Qualification	Experience
1	B.Tech, B.Sc, B.Pharma	2 Years
2	Diploma in Relevant Field	2 Years

What are the requirements to Import ETO (Ethylene Oxide) Sterilizer

In order to import ETO (Ethylene Oxide) Sterilizers, a License on Form MD 15 is Required from the CDSCO. This license is issued from the Head Quarters in Delhi. Application for this license is made on MD 7 to the CDSCO. .

The list of Documents Required to Obtain an MD15 License from CDSCO for ETO Sterilizers can Be downloaded from our website’s Download Section. You can also watch videos on the topic on our youtube channel.

What are the government fees for Manufacturing ETO Sterilizer

The government fee for the license to Manufacture ETO Sterilizer on MD 9 is as follows.

Purpose	Fee
License Fee	Rs 50,000
Per Product Fee	Rs 1,000
Retention Fee (License)	Rs 50,000
Retention Fee (Product)	Rs 1,000

What are the government fees for importing ETO Sterilizer for MD 15 by CDSCO?

The government fee for the license to Manufacture ETO Sterilizer on MD 9 is as follows.

Purpose	Fee
License Fee	3000$
Per Product Fee	1500$
Retention Fee (License)	3000$
Retention Fee (Product)	1500$

How Can Pharmadocx Help you In Obtaining License to Manufacture and Import ETO Sterilizers?

We at Pharmadocx Consultants can provide consultation services to firms looking for a license to manufacture or import ETO ( Ethylene Oxide Steriliser) Steriliser. For Manufacturing a license on Form MD9 is required and for Import a license on Form MD 15 is required. Pharmadocx has been providing consultancy to various firms for over 15 years. We have served over 150 medical device companies in our history. We ensure that the clients face no difficulties or hurdles in the way to manufacture and import any medical device. We can also provide you with project reports for your deemed projects. For other Medical Devices which are under Class B, you can view the information by clicking here.

You can contact us at 9996859227 or at [email protected] for guidance and consultation services. We will be happy to serve you in your endeavor. Checklists for all the licenses along with notifications can be downloaded from our website.