Regulatory Framework for In Vitro Diagnostic Devices in India: Current Landscape, Challenges, and Future Perspectives

Despite progress, India's IVD ecosystem remains constrained by fragmented oversight and weak harmonization with global standards. Strengthening regulatory capacity, mandating evidence-based evaluation, and fostering digital health readiness are critical to ensure patient safety and global competitiveness.

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Publication Details

Journal
The Journal of Applied Laboratory Medicine
Published
2025-11-11
DOI
https://doi.org/10.1093/jalm/jfaf164
Citations
2
Primary Topic
Quality and Safety in Healthcare
Type
article
Field-Weighted Citation Impact
7.06
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article

Regulatory Framework for In Vitro Diagnostic Devices in India: Current Landscape, Challenges, and Future Perspectives

Mahima Ramesh, C. Amrutha, Harsh Sah
2 citations
The Journal of Applied Laboratory Medicine
Quality and Safety in Healthcare
7.06
article

Regulatory Framework for In Vitro Diagnostic Devices in India: Current Landscape, Challenges, and Future Perspectives

Mahima Ramesh, C. Amrutha, Harsh Sah
article en
2 citations

Abstract

Despite progress, India's IVD ecosystem remains constrained by fragmented oversight and weak harmonization with global standards. Strengthening regulatory capacity, mandating evidence-based evaluation, and fostering digital health readiness are critical to ensure patient safety and global competitiveness.

The Journal of Applied Laboratory MedicineVol. 11(1)
Sree Chitra Thirunal Institute for Medical Sciences and Technology (IN)
Openalex Percentile: Top 3%
Quality and Safety in Healthcare
7.06
DOISourceOpenAlex
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Regulatory Framework for In Vitro Diagnostic Devices in India: Current Landscape, Challenges, and Future Perspectives — Mahima Ramesh, C. Amrutha, et al. · The Journal of Applied Laboratory Medicine (2025) | TGRS Research Map | TGRS