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CDSCO releases Risk classification of newly notified Medical Devices, IVDs; Details


CDSCO releases Risk classification of newly notified Medical Devices, IVDs; Details

New Delhi: Through a recent notification, country’s central medical device regulator, the Central Drugs Standards Control Organization (CDSCO) has issued a risk classification of newly notified medical devices and IVDs on the basis of their intended use under the provisions of the Medical Devices Rules, 2017.

Medical devices other than in vitro diagnostic medical devices will be classified on the basis of parameters specified in part I of the first schedule, namely low risk as Class A; low to moderate risk as Class B; moderate to high risk as Class C; and high risk as Class D.

In vitro diagnostic medical devices will be classified on the basis of parameters specified in part II of the First Schedule, namely low risk as Class A; low to moderate risk as Class B; moderate to high risk as Class C; and high risk as Class D.

The latest notification issued by CDSCO in this regard reads;

S. No. Notified Category Intended Use Risk Class
 

1.

CT scan Equipment Use of x-ray source and digitally scanned computer technology to create cross-sectional images of the body. Class C
 

 

2.

 

MRI

Equipment

It is a medical imaging procedure using radio waves, magnetic fields, and magnetic field gradients to generate images of organs in the body.  

Class C

 

 

3.

 

Defibrillators

It is a device that automatically analyzes the rhythm of heart of cardiac arrest patients and delivers an electrical shock to the heart for restoring the normal rhythm of heart.  

Class C

 

4.

Dialysis Machine It is used for acute or chronic kidney failure that filters blood to remove excess water and waste products.  

Class C

 

 

5.

 

PET

Equipment

Intended to detect the gamma radiation and positron emitting radionuclides in the body and produce cross-sectional images which reflect the distribution in the body or individual organs.  

Class C

 

 

6.

 

X-Ray Machine

Use of X-rays to diagnose or treat patients by imaging the internal structure of the body to assess the abnormalities in the body.  

Class C

 

7.

Bone marrow cell separator It is a general lab equipment to be used to isolate target cells and cells concentrate from bone and blood.  

Class B

 

8.

Nebulizer It is device used to administer medications in the form of mist to inhale for respiratory disorders. Class C
 

9.

Blood Pressure Monitoring Devices It is device used to measure the diastolic and systolic blood pressures.  

Class B

 

10.

Digital Thermometer It is device used to record the body temperature. Class B
 

11.

*Glucometer It is a device used to measure the concentration of glucose in blood. Class C
 

12.

Organ Preservative Solution Solution for hypothermic flushing, storage and transport of organs and to maintain the organ vitality during transplant into human recipients.  

Class C

*   Glucometer will be regulated under IVD category

Also Read: CDSCO releases Risk classification of Medical Devices and IVDs

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