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

Area of Science:

• Medical Device Regulation
• In Vitro Diagnostics (IVD)
• Public Health Policy

Background:

• India's in vitro diagnostic (IVD) market shows rapid growth.
• Regulatory oversight and enforcement of quality standards have lagged behind market expansion.
• Existing regulations face challenges in implementation, impacting diagnostic reliability.

Purpose of the Study:

• To review India's IVD regulatory framework, including classification, approval, and post-market surveillance.
• To identify challenges within the Indian IVD regulatory system, such as enforcement gaps and compliance issues.
• To compare India's regulatory system with European and US models.

Main Methods:

• Systematic review of India's IVD regulatory framework.
• Analysis of device classification, approval pathways, and quality management.
• Comparative analysis with international regulatory systems (EU, US).

Main Results:

• Persistent gaps in enforcement, quality standards, and post-market surveillance were identified.
• Challenges include inconsistent SME compliance, adoption barriers for standards, and weak surveillance.
• India's system shows shortfalls compared to EU/US in clinical evidence and structured surveillance.

Conclusions:

• India's IVD ecosystem suffers from fragmented oversight and poor global standard harmonization.
• Strengthening regulatory capacity and evidence-based evaluation is crucial.
• Enhancing digital health readiness is vital for patient safety and global competitiveness.