Classification of Medical Device

Classification of Medical Device

Date : 2022-03-07


What are the different Medical Device Classes?

Introduction

Safety, quality and performance of medical devices are regulated under the provisions of the Drugs and Cosmetics Act, 1940. For the regulation of medical devices for their with respect to the import, manufacture, clinical investigation, sale and distribution, the Central Government, after consultation with the Drugs Technical Advisory Board, has notified Medical Devices Rules, 2017 vide G.S.R. 78 (E) dated 31.01.2017 which are to be commence from 01.01.2018.

What are the principle of classification ?

  • Application of the classification provisions be governed by the purpose of the device.

  • If the device is intended to be used in combination with another device, the classification rules apply separately to each of the devices. Accessories are classified in their own right separately from the device with which they are used.

  • Software, which drives a device or influences the use of a device, falls automatically in the same class.

  • If the device is not intended to be used solely or principally in a specific part of the body, it is considered and classified on the basis of the most critical specified use

 

Why Classification Necessary ?

Once a product meets the definition of a medical device , it must then be correctly classified. General medical devices are divided into four categories Class A , Class B, Class C, Class D .

Classification Of Medical Device with contact details-20210930-093202

List of devices along with their Class

Device Name

Notified Device Category

 

Device Name

 

Risk Class

 

Notified Device Category

 

Device Name

 

Risk Class

 

Catheters

Nasopharyngeal Catheter

Class A

Disposable Perfusion Sets

Connector as an perfusion sets

Class A

Surgical Dressing

Surgical dressings

Class A

Surgical Dressing

umbilical occlusion device

Class A

Surgical Dressing

Bolster Suture

Class A

Surgical Dressing

Alcohol Swobs

Class A

Catheters

Fiberoptic Oximeter Catheter

Class B

Catheters

A-V-shunt or Fistula Adapter

Class B

Catheters

Transcervical Endoscope and accessories

Class B

Catheters

Forceps endooscopic

Class B

Catheters

Anaesthetic Conduction set

Class C

Catheters

Transabdominal

Class C

Catheters

Angiographic Guide wire

Class D

Catheters

Cardiac Catherization Kit

Class D

Catheters

Vena Cava Filter sets

Class D

Our Specification

  • Guidance of our expert team .

  • We help you to classify your device .

  • Provide all information related to classification .

  • Solve each and every query of our clients .

  • Client Satisfaction is our fundamental principal.

Conclusion :

We at ELT Corporate Private Limited, are Medical Device having team of experts provide each and every services under one roof Contact us for Expert device. To know more information contact us.


Author : Medical Device Registration