Vol. 7, Issue 7 (2018)

Author(s):
Chavali Vindu Bhargavi Yadav, Tangirala Aruna, MV Nagabhushanam, Brahmaiah Bonthagarala, D Nagarjuna Reddy and G Ramakrishna

Abstract:
This document was produced by the Global Harmonization Task Force, a voluntary consortium of representatives from medical device Regulatory Authorities and trade associations from around the world. The document is intended to provide non-binding guidance to Regulatory Authorities for use in the regulation of medical devices and has been subject to consultation throughout its development and endorsement by the current Chair. Regulatory controls are intended to safeguard the health and safety of patients, users and others. The level of controls will depend on the identified risks associated with devices. The level of premarket intervention by the regulator is proportional to the level of potential risk and established through a classification system.