OBJECTIVES-

RECENT DEVELOPMENTS AND CHALLENGES IN INDIA

METHODS- BY REVIEW OF LITERATURE

RESULTS : - The global medical device market is growing very fast from last decade and India had shown tremendous growth in this market and it is expected to grow in upcoming years. The new rules have been formulated to promote domestic manufacturing and to regulate import and manufacturing in the region. Currently, multinational companies occupy approximately 75 present of sales in the Indian medical device market. The new regulations follow the GHTF (Global Harmonisation Task Force) guidelines and are in consonance with these rules risk-based classification. In addition, inspections by notified bodies have been introduced in the new medical devices rules. This article explains medical device classification, rules, manufacturer registration procedures, dossier filing procedures and marketing application approval processes and some of the challenges faced by the manufacturer

CONCLUSIONS-

The Medical Device Rules, 2017 have many attractive features that encourage the medical device sector in India. By introducing a single online portal, the registration process has been streamlined. The government audit facility included in the new rules will enforce and ensure higher quality products enter the medical device market in India. An audit by the notified bodies will further increase the manufacturing quality of devices. The role of state licensing authority and central licensing authority is visibly outlined in the rule which in turn will help the manufacturer while filing the application. There are few areas which can be overlooked by the authorities like Medical devices incorporating software and standalone medical device software, and the timelines required for the approval of Class B, C and D can be reduced.