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Classification of Medical Devices in India

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Classification of medical devices in India

Medical devices in India are classified by CDSCO, Central Licensing Authority.

Medical device other than in-vitro diagnostic medical devices are classified on basis of:

  • Risk
  • Intended purpose
  • Duration of contact
  • Invasiveness- non-invasive, invasive with respect of body orifice, surgically invasive

Medical devices other than in vitro diagnostic medical devices shall be classified as:

  • 1.low risk – Class A; eg. Adsorbent cotton wool
  • 2.low moderate risk- Class B; eg. Digital thermometer
  • 3.moderate high risk- Class C; eg. Bone plate, bone screw
  • 4.high risk- Class D; eg. Heart valve
Indian-mdr-img

In-vitro diagnostic devices are classified on basis of:

  • Risk
  • Intended purpose

In vitro diagnostic medical devices shall be classified as: —

  • 1.low risk – Class A;
  • 2.low moderate risk- Class B; eg. Influenza B Antibody test reagents and kits
  • 3.moderate high risk- Class C; eg. Herpes simplex virus reagent/ kits
  • 4.high risk- Class D; eg. HIV test reagents/kits

Notified Device

Notified medical devices are the once which require registration CDSCO has published a list of notified medical devices and In vitro diagnostic devices which are regulated by CDSCO and for which license to import, manufacture, sale and distribution can be obtained.

Non-Notified Device

As per CDSCO, no registration is required for import or manufacturing of non-notified devices. However, these are regulated as drugs under drugs and cosmetics act and rules.

The CDSCO has released two notices on September 3, 2020 which includes classification of non-notified medical devices and in-vitro diagnostic devices. Currently only the draft of classification of such device is proposed. To facilitate the classification, CDSCO has divided medical devices in 24 categories on the basis of first schedule of medical device rule 2017 and 3 categories on non-notified In-vitro diagnostic devices.

Guidance issued by Government of India on 3rd Sep 2020 regarding Device Classification of Non-Notified Devices.

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