Anmol Wadhwa, Sushama Talegaonkar* and Harvinder Popli Pages 212 - 230 ( 19 )
Objective: Medical device acceptance of patients has grown considerably in recent years. This has question the effectiveness of the current regulatory frameworks to ensure the performance, safety, and quality of new devices. This article focuses on the methodical overview on hip and knee joint replacement medical devices evaluating the procedure and proper analysis of medical device regulation in three jurisdictions i.e. the United States of America (USA), EUROPE and INDIA, exploring reforms been laid to stabilize and meet the requirements of existing systems, and further analyse the additional actions which should be employed to fully meet this ultimate goal.
Methods: We analysed the hip and knee joint replacement medical device regulation system through a secondary research in United States, Europe and India in compliance with the updated national regulatory authority’s legislative documents and requirements.
Results: These three regulatory systems vary in their working, organization, acceptance for their specific pre- and post-market evidence requirements, and transparency of process. The most challenging factor remains the same for the countries which are to make sure safety and effectiveness of devices, proper monitoring of its use and important compliance information readiness employing quality management system towards new findings and acceptance for the users. A case study of Johnson & Johnson ASR Implant was also studied, highlighting the major reforms required and the reforms introduced in the United States, Europe and India. Thus, quality and safety reforms are made to strengthen the premarket compliance requirements, enhancing the need of post-market regulation through proper traceability and monitoring of devices by employing the functioning medical device registry.
Conclusion: Recent reforms address the major challenges in device regulation, highlighting the need to create connecting points between the device identifier system and existing data collection tools, such as electronic health records, and maintaining effective and up to date use of registries to ensure post-market use of new and existing devices.
Medical device, knee joint replacement, hip joint replacement, THR, TKR, pharmacological.
Department of Drug Regulatory Affairs, Delhi Pharmaceutical Sciences and Research University (DPSRU), New Delhi, 110017, Department of Drug Regulatory Affairs, Delhi Pharmaceutical Sciences and Research University (DPSRU), New Delhi, 110017, Department of Drug Regulatory Affairs, Delhi Pharmaceutical Sciences and Research University (DPSRU), New Delhi, 110017