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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.
