Regulatory aspects of bioactive glass

S. Lindgren

T. Pänkäläinen

J. Lucchesi

F. Ollila,     BonAlive Biomaterials Ltd, Finland


This chapter will survey the regulatory requirements that medical device (including bioactive glass) manufacturers have to follow in order to set their products on the market. The first part provides an introduction to the critical requirements that need to be met to ensure the safety and effectiveness of the product, while the second part concentrates on the specific requirements that relate to different indication areas and the particular risks involved to the patient. The final part will give an overview of the market approval processes in the EU and the USA, together with a summary of authorities ...

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