CDSCO classifies In-Vitro Diagnostic Medical Devices under Medical Device Rules, 2017

The Central Drugs Standard Control Organisation (CDSCO) has issued a notice classifying In-Vitro Diagnostic Medical Devices under Medical Device Rules, 2017. This notice was issued on 25th October, 2023.

This classification has been undertaken on the basis of intended use, risk associated with the device and other parameters.

By the present notice, CDSCO has updated the following two lists under the Medical Device Rules, 2017:

• Annexure A: List of In-Vitro Diagnostic Medical Devices (IVD Analyzers)

This list now contains a total of 72 medical devices.

• Annexure B: List of In-Vitro Diagnostic Medical Devices (IVD Instruments)

This list now contains a total of 28 medical devices, all of which have been classified as class A. It also includes any other instrument not expressly stated in the list but intended for diagnostic purpose.

Annexure C: List of In-Vitro Diagnostic Medical Devices (IVD Software)

It is important to note that software which drives a device or influences the use of a device, falls automatically in the same class.

CDSCO has also added the following two lists under the Medical Device Rules, 2017:

• Annexure D: List of In-Vitro Diagnostic Medical Devices (IVD- Specimen receptacle)

This list contains a total of 5 medical devices, all of which have been classified as class A.

• Annexure E: List of In-Vitro Diagnostic Medical Devices under provisions of sub-rule (2) rule 4 of the Medical Devices Rules, 2017