Abstract

REGULATORY PERSPECTIVE OF ORTHOPAEDIC IMPLANT IN INDIA

Neha D. Meshram*, Diksha V. Moon, Suankit Harne, Dinesh Biyani, Vinita Kale and Milind Umekar

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Abstract

Medical devices are regulated by the Drug Controller General of India (DCGI) within the Central Drugs Standard Control Organization (CDSCO), part of the Ministry of Health and Family Welfare. There are several medical devices companies in India. Only 7% of implant are made in India and which is classified in class III (moderate-high) medical devices. India has 75% medical devices import market and US contributes the largest proportion. The export supply of medical devices from US involves high risk items such as cardiac stents, orthopaedic implants, and diagnostic equipment. The need of import regulation for class III devices (Orthopaedic implants) to improve long-term patient safety by reducing complication and also requires supervisions to conduct premarket safety assessments. So, we can conclude that in upcoming era this implants will help in greater compliance with patients hence improving quality life of patient and will train health care professional.

Keywords: orthopaedic implants, import regulation.