A Shifting Paradigm of Indian Orthapaedic Medical Device Industry, Post Implimentation of New Medical Device Rules-2017-A Real World Scenario

Abstract

This study talks about brief introduction of medical devices and its classification in INDIA and also the regulatory requirements post implementation of MDR-2017 in contrast to real world scenario (USA & EU). The study also describes the regulatory approval framework for device marketing in INDIA, USA & EU. Further as the topic describes the shifting of the situation of Indian orthopaedic medical device manufacturers after the implementation of new medical device rules-2017. The study covers brief understanding about orthopaedic medical device market domestic and global, along with that describes the product specific classification of orthopaedic medical devices in INDIA.USA & EU, thereby giving the difference of classification systems between these nations. Now development of a standardised procedure for Indian medical device manufacturers for manufacturing of orthopaedic medical device in accordance to ISO-13485 process so as to develop safe, effective and quality device. It also includes the list of ISO/BIS/ASTM standards specific for orthopaedic devices and product category wise classification of required standards. In the end several case studies showing the faults and recalls of the orthopaedic implants in INIDIA and also around the globe. It is mentioned that there is need for stringent regulation and standard implication in the orthopaedic device manufacturing to ensure patient’s safety and for betterment of life worldwide.