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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. CliRead more
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.
See lessWhat actions related to safety should be described in the PSUR?
As per the Seventh Schedule of the Medical Devices Rules, 2017, the Periodic Safety Update Report (PSUR) should include the following actions related to safety: - Safety-related actions: Any new or ongoing safety-related actions, including recalls, field safety corrective actions, and other risk minRead more
As per the Seventh Schedule of the Medical Devices Rules, 2017, the Periodic Safety Update Report (PSUR) should include the following actions related to safety:
– Safety-related actions: Any new or ongoing safety-related actions, including recalls, field safety corrective actions, and other risk minimization measures.
See less– Changes to reference safety information: Any changes to the product information or labeling related to safety.
– Signal and risk evaluation: Evaluation of new safety signals and any changes to the known risks associated with the medical device.
– Overall safety evaluation: An overall assessment of the benefit-risk profile of the medical device.