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India’s medical device ecosystem is undergoing one of its fastest periods of regulatory growth, and the clearest indicator is the sharp rise in Class A and Class B registrations across therapeutic categories. As 2025 unfolds, this trend is expected to accelerate even further, driven by a mix of regulatory reforms, increased market demand, and the […]
Introduction ASEAN continues to take major steps toward regional regulatory convergence in medical devices, with Malaysia emerging as a driving force behind innovative reliance models. Following the successful Malaysia–China Regulatory Reliance Programme, Malaysia and Singapore have now launched a joint pilot to fast-track medical device registrations across both nations. These bilateral frameworks are designed to
Regulatory Collaboration in ASEAN: The Malaysia–Singapore Reliance Pilot Explained Read More »
Introduction Malaysia has rapidly emerged as one of ASEAN’s key medical device markets, driven by growing healthcare infrastructure, increasing demand for innovative devices, and a regulatory system aligned with international standards.For manufacturers and regulatory professionals aiming to enter this market, understanding the Medical Device Conformity Assessment process is essential. This process, governed by the Medical
Understanding Malaysia’s Medical Device Conformity Assessment Framework Read More »
Introduction: The Shift Toward Home-Based Healthcare in India India’s healthcare landscape is undergoing a major transformation. As patients increasingly prefer convenience, affordability, and real-time access to care, home-based healthcare and remote patient monitoring (RPM) have emerged as powerful solutions bridging the gap between hospitals and homes. According to a 2024 NASSCOM report, India’s digital health
India’s Regulatory Roadmap for Home & Remote Patient Monitoring Devices Read More »
The meeting is about providing guidance on the regulations and requirements for Medical Device Software in India, as outlined in a draft guidance document by the Central Drugs Standard Control Organization (CDSCO). Draft Guidance Document on Medical Device Software This document outlines the regulatory framework for Medical Device Software under the Medical Devices Rules, 2017,
Draft Regulatory Requirements Guidance Document for Medical Device Software Read More »
1. Introduction: Why PMS Is Critical for Respiratory Devices Respiratory devices such as ventilators, oxygen concentrators, CPAP/BiPAP units, and nebulizers play a pivotal role in supporting or sustaining breathing. Unlike many lower-risk medical devices, these instruments operate in direct interface with patients’ respiratory systems, often in life-critical scenarios. Even minor failures—such as alarm mis-triggering, sensor
Post-Market Surveillance (PMS) Obligations for Respiratory Devices in India Read More »
