Pharmaceutical Regulatory Affairs: Open Access

Kazuhisa Koike

Publications

• Research Article
  Nationwide Registries Associated with Cardiovascular Medical Devices in Japan
  Author(s): Nobuhiro Handa, Kensuke Ishii, Kazuhisa Koike, Hiraku Kumamaru, Hiroaki Miyata and Noboru MotomuraNobuhiro Handa, Kensuke Ishii, Kazuhisa Koike, Hiraku Kumamaru, Hiroaki Miyata and Noboru Motomura
  
  Background: Nationwide medical device registries have the potential to provide real world data for regulatory purposes. The objective of this article is to assess how to develop and manage Nationwide Registries Associated with Cardiovascular Medical Devices (NRACMD). Methods: A questionnaire comprising of 43 items was designed to clarify the quality, characteristics, utility and sustainability of existing NRACMD in Japan. It was then sent to various organizing bodies. Findings: Eight organizations responded to the questionnaire. Three NRACMD were device-specific registries in which the patient was registered when a device was used. The others were procedure-specific registries. Six registries covered more than 95% of target population and two covered 80-95%. Five registries were associated with specialty board certific.. Read More»
  DOI: 10.4172/2167-7689.1000177

  Abstract PDF