On January 6, 2025, the Central Drugs Standard Control Organistion (CDSCO) of India released a draft updating on existing risk-based medical device classification list.
This update includes reclassification and new classifications for the following categories:
1. Interventional Radiology
2. Radiotherapy
3. Oncology
4. Class A (Non-Sterile and Non-measuring) medical devices
The updated guideline in India have expanded the number of classification items compared to the previous guideline on medical device classification. Additionally, some medical device items have been upgraded and downgraded in terms of classification. A comparison table of the number of classification items between the previous and updated guidelines is as follows:
| Category | Interventional Radiology | Radiotherapy | Oncology | Class A (non-sterile and non-measuring) medical devices |
|
| Total No. of Devices | Classification of MDs (2021, 2022) | 66 | 101 | 48 | N/A |
| Classification of MDs draft (2025) | 186 | 114 | 75 | 803 | |
In the future, once the draft guideline is finalized, significant revisions will be made to the existing medical device classification list.
Please refer to the attached document below.
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