The document outlines the risk-based classification of medical devices, categorizing them based on the intended use and risk level. Stakeholders are invited to submit comments within 30 days of publication. Devices range from Class A (low risk) to Class D (high risk), covering interventional radiology, oncology, and radiotherapy. This classification aims to streamline regulatory oversight and ensure patient safety.
The draft document, published on 06 January 2025, seeks stakeholder comments within 30 days. It is governed by the Medical Device Rules, 2017, under the Drugs and Cosmetics Act, 1940, and regulated by the Central Drugs Standard Control Organization (CDSCO). The classification framework ensures compliance with safety and performance standards for medical devices used in healthcare.
Key Points:
- Legal Framework: Aligned with the Drugs and Cosmetics Act, 1940, and Medical Device Rules, 2017.
- Regulatory Authority: CDSCO, responsible for medical device oversight.
Classification Based on Risk:
- Class A: Low-risk (non-sterile, non-measuring).
- Class B: Moderate-risk (e.g., ultrasound transducers).
- Class C: High-risk (e.g., angiographic X-ray systems).
- Class D: Highest risk (e.g., radiation-emitting devices).
- Focus Areas: Interventional radiology, radiotherapy, and oncology.
- Compliance Timeline: Comments to be submitted via the provided Google form before the deadline