CDSCO Classifies 12 Newly Notified Medical Devices

On May 15, 2019, Central Drugs Standard Control Organization (CDSCO) of India has published a notification regarding the classification of new devices, which are notified for regulation. As per the notification, the newly regulated medical and in vitro diagnostic (IVD) devices will be classified as per the provisions of Medical Device Rules – 2017. Basing on the rules, the classification criteria are decoded below.

All medical devices except IVD devices will be classified based on parameters specified in part I of the first schedule. IVD devices will be classified based on parameters specified in part II of the first schedule. In both the cases, the devices are classified as:

  • Class A – Low-risk devices
  • Class B – Low to moderate-risk devices
  • Class C – Moderate to high-risk devices
  • Class D – High-risk devices

In recent times, the CDSCO has added 12 device types in two phases (phase I - 4 types and phase II – 8 types) to the list of regulated medical devices. Amending the list, the agency has replaced the implantable device type with organ preservative solution. As per the notification, here are the designated classes for the newly notified devices.

Notified Medical / IVD Device Category

Device Class

CT scan equipment

Class C

MRI equipment

Class C

Defibrillators

Class C

Dialysis machine

Class C

PET equipment

Class C

X-ray machine

Class C

Bone marrow cell separator

Class B

Nebulizer

Class C

Blood pressure monitoring device

Class B

Digital thermometer

Class B

Glucometer (IVD category)

Class C

Organ preservative solution

Class C

With the Medical Device Rules – 2017 set to come into effect from April 1, 2020, as per the revisions, the list of devices to be regulated and classified is expected to grow. To ensure compliance, manufacturers must decode the guidelines of the new rules, keep a track of the changes and classify the devices accordingly. Stay informed and compliant.