Professional paper

https://doi.org/10.5599/admet.1.4.19

On the evaluation of the safety aspects of nanomaterials in medical devices – a regulatory perspective

Eva Wu ; Office of Medical Device Evaluation, Center for Measurement Standards, Industrial Technology Research Institute, Taiwan
Christopher Chan ; Office of Medical Device Evaluation, Center for Measurement Standards, Industrial Technology Research Institute, Taiwan
Albert Li ; Office of Medical Device Evaluation, Center for Measurement Standards, Industrial Technology Research Institute, Taiwan

Abstract

Nanotechnology is widely used in many aspects of the design and manufacture of medical devices. To date, many of these new medical devices, referred to as nano medical devices, have been submitted to health authorities for premarket regulatory review. There are ongoing discussions between medical device manufacturers and regulatory authorities regarding the standards and methods required for the evaluation process. Taking into consideration aspects including nano-toxicology and biocompatibility, the 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.

Keywords

nanotechnology; nanomaterial; regulatory; medical device; risk management; usability

Hrčak ID:

112510

URI

https://hrcak.srce.hr/112510

Publication date:

16.12.2013.

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