A Leap for Medical Devices Regulation in India and its Comparison with United States and European Union Regulations
DOI:
https://doi.org/10.70411/MJHAS.2.1.2025147Keywords:
Medical Device, Device Classification, Medical Devices Rules., Quality Management System, Risk AssessmentAbstract
The Indian medical devices sector is the sunrise sector and holds the potential to quickly become one of the top countries in the global medical devices market share. In the patient-centric era, this paper aims to comprehensively analyze medical device regulations in India and compare them horizontally with United States U.S. and European Union (EU) regulations. Data from open sources, such as reports, different search engines, etc., were considered for an in-depth analysis of the regulatory landscape in India, the US, and the EU. One of the significant comparative findings indicated that CE (European Conformity) is essential to EU regulation for ensuring medical devices' safety and effectiveness (efficacy). In contrast, notified bodies/central licensing authority (CLA) in India and U.S. Center for Medical Devices and Radiological Health (CDRH) perform the same. Variations in device classification, pre-market approval requirements, post-market surveillance, validity period, and quality management systems were also observed.
Despite significant developments in the medical devices rules (MDR)-2017, various challenges such as specific compliances for software as medical devices (SaMD), futuristic healthcare technologies regulations, and limited designated labs for performance evaluation of In-vitro diagnostics (IVD) medical devices, which needs to be addressed enabling multiple fold increment in the medical device market share. Recommendations include creating a unique quick response (QR) code for each medical device, creating a database of technical information on approved devices, and strengthening materiovigilance. These steps are essential to ensuring the quality and safety of medical devices and enhancing their competitiveness in the global market.
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