CDSCO notified regarding the updation of existing risk-based classification lists

Jan 10, 2025 | by TeamLease RegTech Legal Research Team

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Industry Specific ComplianceThe Central Drugs Standard Control Organization (CDSCO) on January 06, 2025, notified regarding the updation of existing risk-based classification lists.

The existing classification lists of the following categories have been revisited and new entries have been added based on their classification as per the First Schedule (Part I) of the MDR, 2017 and the internationally-followed classification:

• Interventional Radiology

• Radiotherapy

• Oncology

• Class A (non-sterile and non-measuring) medical devices

The draft of the classification lists is annexed for finalization. All concerned associations/stakeholders are requested to forward their comments by filling the Google form (Link: https://docs.google.com/forms/d/1e-FFEU6wVU9nxgE-B40lJfeFdaMHxO_Y1jxUiQSq2sw/edit?pli=1) within 30 days from the date of publication of this draft.

[File No. MED-16014(12)/1/2024-eoffice]


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