Thermometer comes under which class of medical device?

From the list of notified medical devices, we have the following related devices:

1. Clinical electronic thermometer:
– Intended Use: A device used to measure the body temperature of a patient.
– Notification details: dated 3 Sept, 2020 with File. No.29/Misc/03/2020-DC (200)
– Device class: B

2. Clinical mercury thermometer:
– Intended Use: A device used to measure oral, rectal, or axillary (armpit) body temperature using the thermal expansion of mercury.
– Notification details: dated 3 Sept, 2020 with File. No.29/Misc/03/2020-DC (200)
– Device class: B

3. Clinical color change thermometer:
– Intended Use: A disposable device used to measure a patient’s oral, rectal, or axillary (armpit) body temperature.
– Notification details: dated 3 Sept, 2020 with File. No.29/Misc/03/2020-DC (200)
– Device class: A

Based on the information provided in the Medical Device Rules, 2017, the classification of a thermometer as a medical device in India would be as follows:

As per the Basic Principles and parameters for classification, a thermometer is a measuring device that is used for diagnosis. It does not have a significant potential for causing harm to the patient.

Referring to the notified devices, the clinical electronic thermometer and clinical mercury thermometer are classified as Class B devices, while the clinical color change thermometer is classified as a Class A device.

Therefore, the most likely class for a thermometer as a medical device in India would be Class B, as it is a measuring device used for diagnosis with a moderate level of risk.