Last Updated on April 5, 2025 by The Health Master
Medical Devices
The Central Drugs Standard Control Organisation (CDSCO), has recently issued a draft of the revised classification for medical devices falling under the categories of cardiovascular and neurological.
This proactive approach aims to align the classification of medical devices with international standards.
Why the updating?
The notice from the CDSCO published on April 1, 2025, mentions that as per the notification vide S.O. 648(E) dated February 11, 2020, all medical devices are regulated under the Medical Devices Rule (MDR) 2017.
The CDSCO has taken this decision to update the classification of these medical devices, keeping in mind the high-risk medical devices, as mandated under the MDR 2017.
This approach, which is also in line with the guidelines set forth by the International Medical Device Regulators Forum (IMDRF), emphasizes categorizing medical devices based on their potential risk to patients.
By revising these classifications, the CDSCO aims to move towards a more transparent and efficient regulatory pathway, which will finally be useful for both manufacturers and patients.
A Comprehensive Overhaul
The newly released draft encompasses an extensive list of 553 medical devices, specifically targeting the cardiovascular and neurological specialties.
A detailed breakdown is as follows:
Cardiovascular Medical Devices:
A total of 351 medical devices used for diagnosing and treating heart-related conditions are included.
Neurological Medical Devices:
A total of 202 medical devices are used for addressing disorders of the nervous system.
The draft classification further divides these medical devices into four risk classes:
Class A (Low Risk): This category includes medical devices posing the lowest potential risk to patients. The draft includes 25 medical devices in Class A.
Class B (Medium Risk): Medical Devices with a moderate risk profile are placed in this category. The draft includes 153 medical devices in Class B.
Class C (High Risk): Medical devices with a higher potential for risk. The draft includes 151 medical devices in Class C.
Class D (Highest Risk): Medical Devices that carry the highest potential risk to patients. The draft includes 221 medical devices in Class D.
Stakeholder Input Matters
Keeping in view the importance of inputs from the stakeholders, the CDSCO has invited feedback from all stakeholders, including medical device manufacturers, healthcare professionals, and the associations of medical devices.
A 30-day time has been given for submitting comments and suggestions on the draft classification list, which will start from April 1, 2025.
The CDSCO has also provided a dedicated Google Form for responses from the stakeholder.
Q. What is the aim of this revision?
A. The updating of the classification of cardiovascular and neurological medical devices aims to align the classification with the Medical Devices Rules, 2017, and international regulations.
Q. How many medical devices are included in this update?
A. The revised draft list includes 553 medical devices specifically used for cardiovascular and neurological problems.
Q. What are the different classes of medical devices?
A. Medical devices are classified into four classes: A (lowest risk), B (medium risk), C (high risk), and D (highest risk).
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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