Last Updated on January 8, 2025 by The Health Master
Classification of Medical Devices
Drugs Controller General (India) (DCGI), on 06-01-2025 has issued a notice for updating of classification of medical devices as per the risk base approach and seeking comments from the stake holders within 30 days.
All the medical devices are regulated under Medical Devices Rules 2017 (MDR 2017), as per the notification vide No. S.O. 648(E) dated 11-02-2020.
Rule 4(3) of the MDR 2017
The Central Licensing Authority needs to classify medical devices as per risk-based approach, in accordance to the Rule 4(3) of chapter II of the MDR 2017.
In this connection, the existing list of classification of medical devices of the following categories have been revisited and new entries have been made based on their classification as per the first schedule (part-I)of MDR 2017 and the internationally followed classification.
New entries to the existing list:
The CDSCO has identified four primary categories of medical devices subject to risk-based classification of medical devices under the Medical Devices Rules (MDR), 2017:
- Interventional Radiology Devices: 186 medical devices
- Radiotherapy Devices: 114 medical devices.
- Oncology Devices: 75 medical devices.
- Class A Non-Sterile and Non-Measuring Medical Devices: 803 medical devices.
Public comments and Feedback
The CDSCO encourages all the stakeholders, including medical device manufacturers, industry associations and healthcare professionals for providing their comments and feedback on the proposed risk-based classification of medical devices.
This feedback is very important for refining the classification system of medical devices.
Procedure to Provide Feedback
Stakeholders can submit their comments and feedback through an online Google form, link given below:
https://docs.google.com/forms/d/1e-FFEU6wVU9nxgE-B40lJfeFdaMHxO_Y1jxUiQSq2sw/edit?pli=1.
The last date for submitting feedback is 30 days from the date of publication of this draft classification list.
Which are the new entries to the existing list of classification of medical devices?:
Interventional Radiology Devices: 186 medical devices
Radiotherapy Devices: 114 medical devices.
Oncology Devices: 75 medical devices.
Class A Non-Sterile and Non-Measuring Medical Devices: 803 medical devices.
How can I provide comment and feedback on the proposed risk classification categories?
Stakeholders can submit their comments and feedback through an online Google form, link given below: https://docs.google.com/forms/d/1e-FFEU6wVU9nxgE-B40lJfeFdaMHxO_Y1jxUiQSq2sw/edit?pli=1
What is the last date for submitting comment and feedback?
The last date for submitting comments and feedback is 30 days from the date of publication of the draft classification list.
Disclaimer: This article contains information obtained from the source mentioned below. Our team made changes in the format to rewrite and present the news or article in a unique format.
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