A number of Licenses are Required for import and Manufacture of thermometers. You will find Complete information regarding CDSCO license to manufacture and import all types of thermometers as per Medical Device Rules, 2017 along with license required for import and manufacture of thermometers, License Procedure, Government Fees explained in depth with links to similar articles.

What are the different types of thermometers as per CDSCO?

The CDSCO with its notification date 15^th May 2019, under the heading “classification of newly notified medical devices” wide file no. 29/Misc/3/2017/-DC(292) has classified thermometers as a risk class B medical Device. Meaning Digital Thermometer is a Low Moderate Risk Medical Device. The above Notification can be downloaded from our downloads section visit :- https://pharmadocx.com/downloads/

The CDSCO with its notification date 16^th March 2022, under the heading “General Hospital/ Orthopaedic” wide file no. 29/Misc/3/2017/-DC(193) has classified Color Change Thermometers as a risk class Aa medical Device. Meaning Clinical Color change thermometer is a Low Risk Medical Device. The above Notification can be downloaded from our downloads section visit :- https://pharmadocx.com/downloads/

Description of Thermometer as per CDSCO Notification as follows.

Type of Thermometer	Description as per CDSCO notification
Digital Thermometer	It is device used to record the body temperature.
Clinical Colour Change Thermometer	A clinical color change thermometer is a disposable device used to measure a patient’s oral, rectal, or axillary (armpit) body temperature

It is to be noted that even though the CDSCO notification has only mentioned digital thermometer as class B product, Mercurial thermometers are also being applied under MD-5 as a class B product. Meaning, Mercurial thermometer is also a class B medical Device.

What are the different types of Thermometers and their risk classes?

• Digital thermometer is a risk class B medical Device as per Medical Device Rules, 2017
• Mercurial thermometer is a risk class B medical Device as per Medical Device Rules, 2017
• Infrared Thermometer or Non-Contact Thermometer is a risk class B medical Device as per Medical Device Rules, 2017
• Clinical Color Change Thermometer is a risk class A medical Device as per Medical Device Rules, 2017

What are the requirements to import and manufacture Class A Clinical Color Change Thermometer?

Clinical color change thermometer has to be registered as per Chapter IIIB of the medical device rules, 2017. Pharmadocx consultants guide you in registration for Import and Manufacture of Class A Clinical Color Change Thermometers. For registration for Class A products following documents are required

1. Aadhar Card
2. Pan Card
3. GST certificate
4. CIN
5. ISO 13485
6. Free Sale Certificate

The government fee for the registration of thermometers of class A on the online portal is INR 0. The government Notification regarding this can be downloaded from our website’s download section or by clicking here.

You can also watch Video on the topic of Class A devices on our Youtube Channel “Pharmadocx Consultants“.

Once the registration is completed, A file number is generated automatically. This shall be printed on the label of the product being imported or manufactured. The file number is auto generated based on self-compliance undertaking by the manufacturer/ Importer.

Note: Class B thermometers like Digital Thermometer, Mercurial Thermometer, Infrared Thermometer cannot be registered as per the above process. License on form MD5 must be taken in order to manufacture Digital thermometer, Mercurial thermometer, and Non-Contact Thermometer. And a license on form MD 15 must be obtained in order to import Digital thermometer, Mercurial thermometer, and Non-Contact Thermometer.

What are the requirements for manufacture of Digital, Mercurial or Non-Contact Thermometer?

In order to manufacture Digital Thermometer (It is device used to record the body temperature) or Mercurial thermometer (It is device used to record the body temperature) or Non-Contact thermometer (It is device used to record the body temperature without making contact with the body) A license is required on Form MD5. The government fees for the license to manufacture of class B is Rs 5000 (license fee) and Rs 500 (per product).

Prior to grant of this license an audit is conducted of your factory. It is conducted as per the requirements of medical device rules, 2017 & ISO 13485:2016. This audit of the premises is conducted by NABCB bodies. There are a total of 13 NABCB approved bodies in India for audit of class B medical Devices. The checklist for the documents required for application for license to manufacture Class B thermometers can be downloaded using the link given below. The entire process from the time of application takes to grant of license takes about 4 months to complete

We at Pharmadocx Consultants can provide consultation services for obtaining license to manufacture Thermometers on form MD5. Feel free to Contact Us for consultancy regarding manufacturing of Thermometers

What are the requirements for import of Digital, Mercurial or Non-Contact Thermometer?

In Order to import Any Class B thermometer a License is required on form MD 15.

In order to import Digital Thermometer (It is device used to record the body temperature) or Mercurial thermometer (It is device used to record the body temperature) or Non-Contact thermometer (It is device used to record the body temperature without making contact with the body) A license is required on Form MD15. The government fees for the license to Import Class B Thermometer is USD 2000$ (license fee) and USD 1000$ (per product).

In case of import, audit of the factory is not conducted. The checklist for documents required in order to import Digital Thermometer, Mercurial Thermometer, Non-Contact Thermometer can be downloaded from the link given below. The entire process from the time of application takes to grant of license to import Digital Thermometer, Mercurial Thermometer, Non-Contact Thermometer takes about 4 months to complete

What is the government fee for manufacturing license of Class B Digital Thermometer, Mercurial Thermometer, Non-Contact Thermometer on MD5?

The government fee for Manufacturing License on Form MD5 for Non Contact, Mercurial, Digital Thermometer is Rs 5000 for license and Rs 500 per product.

Thermometer	License Fee	Per Product Fee
Digital Thermometer OR Mercurial Thermometer OR Non-Contact Thermometer	Rs 5,000	Rs 500

What is the government fee for import license of Class B Digital, Mercurial or Non-Contact Thermometer?

The government fee for import License on Form MD5 for Non Contact, Mercurial, Digital Thermometer is USD 2000 for license and USD 1000 per product.

Thermometer	License Fee	Per Product Fee
Digital Thermometer OR Mercurial Thermometer OR Non-Contact Thermometer	USD 2,000	USD 1,000

What is the government fee for registration for import or manufacture class A Clinical Color Change Thermometer?

There is no government fee for registration of Clinical Color Change Thermometer) of Class A for both manufacturing and import.

Is ISO mandatory for a license to Manufacture Thermometer?

As per the list of documents required for license to manufacture Medical Devices, ISO 13485 is mandatory. However this does not mean you cannot apply for a license to manufacture Class B medical devices without an ISO certificate. The process of procuring an ISO certificate can be done simultaneously while procuring the license on form MD 5.

The audit for both ISO 13485:2016 and IMDR can be done simultaneously and hence saving precious time before grant of license on form MD5

What Are Oral Digital Thermometers?

Oral digital thermometers are a type of thermometer that measure a person’s body temperature by placing a digital thermometer probe under the tongue. They are similar in design to traditional oral thermometers, but instead of a mercury or alcohol-filled glass tube, they use a digital display to show the temperature reading.

The digital display makes it easy to read the temperature measurement quickly and accurately. Many digital thermometers also have features such as memory recall, which allows the user to view past temperature readings, and fever alarms, which sound an alert when the temperature reading is above a certain threshold.

Oral digital thermometers are widely used in homes and medical settings because they are easy to use and provide accurate temperature readings. They are also relatively inexpensive and widely available. Some models also have additional features such as the ability to switch between Fahrenheit and Celsius temperature scales and automatic shut-off to conserve battery life.

To manufacture oral digital thermometers a license on form MD5 is required as per Medical Device Rules, 2017 and a license on form MD15 is required to Import Oral Digital Thermometers as per Medical Device Rules, 2017

What are mercurial thermometers?

Oral mercurial thermometers are a type of thermometer that use a column of mercury to measure a person’s body temperature when placed under the tongue. The thermometer typically consists of a slender glass tube with a silver tip containing mercury, which expands as it heats up, and rises up the tube to indicate the temperature.

These thermometers were commonly used in households and medical settings before the widespread use of digital thermometers. However, due to safety concerns regarding the handling and disposal of mercury, the use of oral mercurial thermometers has decreased significantly.

Mercury is a toxic substance that can be harmful if inhaled, ingested or absorbed through the skin. If an oral mercurial thermometer breaks, the mercury can escape and create a hazardous situation. For this reason, many countries have banned the use of mercury thermometers, including oral mercurial thermometers, in healthcare facilities and some have banned them for use in homes as well.

To manufacture oral mercurial thermometers a license on form MD5 is required as per Medical Device Rules, 2017 and a license on form MD15 is required to Import Oral Mercurial Thermometers as per Medical Device Rules, 2017

What are Non-Contact Thermometers?

Non-contact thermometers, also known as infrared thermometers, are a type of thermometer that measures a person’s body temperature without requiring physical contact with the skin. Instead, they use infrared technology to measure the thermal radiation emitted by the skin and convert it into a temperature reading.

Non-contact thermometers typically consist of a handheld device with a digital display that shows the temperature reading. They are held a few inches away from the person’s forehead or temporal artery. The temperature reading is taken quickly and accurately.

Non-contact thermometers are becoming increasingly popular in medical settings. They are also useful for measuring the temperature of objects such as food, liquids, and surfaces.

To manufacture non-contact thermometers a license on form MD5 is required as per Medical Device Rules, 2017 and a license on form MD15 is required to Import non-contact Thermometers as per Medical Device Rules, 2017

How can Pharmadocx Help in Obtaining License to manufacture and Import Thermometers?

We at Pharmadocx Consultants can provide consultation services to firms looking for license to manufacture or import Thermometers. For Digital Thermometer, Mercurial Thermometer, Non-Contact Thermometer.) of Class A and Class B. Pharmadocx has been providing consultancy to various firms throughout 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.

You can contact us on 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