Marketing medical devices in Japan
Ohashi, J.
Medical Device Technology 9(1): 32
1998
ISSN/ISBN: 1048-6690 PMID: 10176143 Document Number: 492447
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.
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