title: Marketing medical devices in Japan.
abstract: The control of medical devices in Japan has recently undergone significant changes as the country brings its systems into line with those of the United States and Europe. This article discusses pre-market approval, quality system requirements and post-market surveillance. Many technical issues have been harmonized but language is likely to continue to be a barrier to trade. Details of information services that are available to foreign manufacturers and importers are supplied.
authors.affiliation: Menicon Co. Ltd., Research and Development Laboratories, Quality Assurance Division, Aichi, Japan.
authors.forename: J
authors.initials: J
authors.lastname: Ohashi
mesh_terms: D004869:Equipment Safety; D004864:Equipment and Supplies / Q000145:classification / Q000592:standards; D005060:Europe; D005069:Evaluation Studies as Topic; D006801:Humans; D007255:Information Services; D007564:Japan; D007802:Language; D008004:Licensure; D008389:Marketing of Health Services / Q000331:legislation & jurisprudence; D011358:Product Surveillance, Postmarketing; D011786:Quality Control; D013672:Technology / Q000592:standards; D014481:United States