A license to Manufacture or Import Steam Sterilizers or Autoclaves has been made compulsory by the CDSCO on forms MD 9 and MD 15. For Manufacturing Steam Sterilizers or Autoclaves a license on MD 9 is required and for Importing Steam Sterilizers or Autoclaves 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 Steam Sterilizers or Autoclaves as moderately high-risk class C Medical Devices. 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 ImportSteam Sterilizers or Autoclaves

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What is the Class of Steam Sterilizers (Autoclave) 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 steam sterilizer (Autoclave) as a moderately high-risk class C Medical Device

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

Description of Steam Sterilizers or Autoclaves as per CDSCO

Sr No. in the List	Name of the Medical Device	Description	Risk Class
45	Steam sterilizer	A steam sterilizer (autoclave) is a device that is intended for use by a healthcare provider to sterilize medical devices by means of pressurized steam	Class C

steam sterilizer (Autoclave) is a Class C product as per CDSCO List on Serial Number 43 for the description “Intended for use by a health care provider that uses pressurized steam to sterilize medical devices” The Above List and Notification can be downloaded from the downloads section of our website.

Description of steam sterilizer (Autoclave) as per CDSCO

As per CDSCO Notification, a Steam sterilizer is defined as a device having intended use “A steam sterilizer (autoclave) is a device that is intended for use by a healthcare provider to sterilize medical devices by means of pressurized steam”.

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

What is a Steam Sterilizer (Autoclave)?

Steam sterilizers, also known as autoclaves, are commonly used in medical facilities to sterilize medical devices and equipment. The process of steam sterilization involves exposing the medical device to high-pressure steam at a high temperature for a specified period of time.

The steam sterilization process works in the following way:

1. The medical device is first cleaned and prepared for sterilization. Any visible debris or contaminants must be removed to ensure the sterilization process is effective.
2. The device is then placed inside the sterilization chamber of the autoclave. The chamber is sealed to prevent steam from escaping.
3. Water is added to the chamber, and the autoclave is heated to a high temperature, typically around 121°C (250°F). The pressure in the chamber is also increased, typically to around 15 psi.
4. The device is exposed to the high-pressure steam for a specified period of time, typically between 15 and 30 minutes. The length of time required for sterilization depends on the size and complexity of the device being sterilized.
5. Once the sterilization cycle is complete, the pressure in the chamber is released, and the device is allowed to cool. The chamber is then opened, and the sterilized device can be removed.

How are Steam Sterilizer (Autoclave) made?

The manufacturing process involves several steps, including:

1. Design and engineering: The first step in the manufacturing process is to design and engineer the autoclave. This involves determining the specifications and features needed for the device, including the size, capacity, pressure, temperature, and controls.
2. Fabrication of the chamber and door: The chamber of the autoclave is typically made from stainless steel, which is durable and resistant to corrosion. The door of the autoclave is also made from stainless steel and is designed to seal tightly to prevent steam from escaping.
3. Installation of heating and pressure components: The autoclave must be equipped with heating elements to generate steam and a pressure vessel to regulate the pressure inside the chamber. The heating elements are typically located at the bottom of the chamber, and the pressure vessel is installed on top.
4. Installation of controls and safety features: The autoclave must be equipped with controls to regulate the temperature and pressure inside the chamber, as well as safety features to prevent over-pressurization and overheating. These features may include pressure relief valves, temperature sensors, and alarms.
5. Testing and quality control: Once the autoclave is assembled, it undergoes testing and quality control to ensure it meets the required specifications and safety standards. This may include testing the performance of the heating and pressure components, as well as conducting pressure and leak tests.
6. Packaging and shipping: Once the autoclave has been tested and approved, it is packaged and shipped to the customer. The autoclave may be partially disassembled for shipping to reduce its size and weight, and it may require on-site installation and calibration by a qualified technician.

What are the requirements to Manufacture Steam Sterilizer (Autoclave)?

In order to manufacture Steam Sterilizer (Autoclave), 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 Steam Sterilizer (Autoclave) 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 Steam Sterilizer (Autoclave). No Objection Certificate from The Pollution Control Board and Fire Office has to be procured.

What are the minimum qualifications for Manufacturing Steam Sterilizer (Autoclave)?

As per CDSCO following are the Minimum qualification and experience requirements to obtain license to manufacture Steam Sterilizer (Autoclave). 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	4 Years

What are the requirements to Import Steam Sterilizer (Autoclave)?

In order to import Steam Sterilizer (Autoclave), 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 Steam Sterilizers can Be downloaded from our website’s Download Section. You can also watch videos on the topic on our youtube channel.

What is the government fees for Manufacturing Steam Sterilizer (Autoclave)?

The government fee for the license to Manufacture Stram Sterilizer (Autoclave) 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 Steam Sterilizer (Autoclave) on form MD 15 by CDSCO?

The government fee for the license to Import Steam Sterilizers (Autoclaves) on MD 9 is as follows.

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

What are the other types of Sterilizers

According to CDSCO there are 3 types of Sterilizers currently covered under Medical Device Notifications.

Sr. No.	Device Name	Intended Use
43	Ethylene oxide gas sterilizer	Intended for use by a health care provider that uses ethylene oxide (ETO) to sterilize medical devices
44	Dry-heat sterilizer	A dry-heat sterilizer is a device that is intended for use by a health care provider to sterilize medical devices by means of dry heat
45	Steam sterilizer	A steam sterilizer (autoclave) is a device that is intended for use by a health care provider to sterilize medical devices by means of pressurized steam

You can read our Blog About the requirements of ETO (Ethylene Oxide) Sterilizers by clicking here. We have also written about the requirements of Dry-Heat Sterilizers

How Can Pharmadocx Help you In Obtaining License to Manufacture and Import Steam Sterilizer (Autoclave)?

We at Pharmadocx Consultants can provide consultation services to firms looking for a license to manufacture or import Steam Sterilizers (Autoclaves). 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. We have written in detail about the process to obtain license for various types of gloves. Feel free to refer the link

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.