On the evaluation of the safety aspects of nanomaterial in medical device – a regulatory perspective

Abstract

Nanotechnology is used widely in many aspects of design and manufacturing of medical device. To date, many of these new medical devices, which are referred to as nano medical devices, are being submitted to the health authorities for premarket regulatory review. There are ongoing discussion between the medical device manufacturers and the regulatory authorities regarding the standards and methods for the evaluation process. Taking into consideration of nano-toxicology and biocompatibility, clinical effects of nanotechnology and risk management, there are issues yet to be resolved. In this article, we will discuss nano medical device safety from the regulatory control point of view.