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  • Feature ArticlesFeature Articles

    Fundamentals and Global Impact of 510(k) for Medical Devices

    This article presents an overview of the fundamentals of 510(k) submissions, including the impact of the unique regulations to US and foreign device manufacturers. Introduction The expansion of the global medical device healthcare market has been evolving rapidly in the 21st century Notably, clinical chemistry analyzers and in vitro diagnostics are estimated to reach $11.7 billion and $75.1 billion respectively by 2019 and 2020. 1, 2 Despite attractive opportunitie...
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    China’s New Medical Devices Importation Regulations: An Overview

    The regulatory environment in China continues to evolve as the market slowly matures. On 11 September 2014, the China Food and Drug Administration (CFDA) issued new regulations for the importation into the country of Class II and Class III medical devices and in vitro diagnostics (IVDs). Administrative Order No. 208 1 took effect 1 October 2014. It is available in Mandarin on CFDA’s website. The most important change occurred to the registration review proce...