Identifying Predicate Devices in India, Taiwan, China, Japan, and Korea
An outline of the best practices for five different Asian countries that provide an abbreviated “predicate” registration route.
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An outline of the best practices for five different Asian countries that provide an abbreviated “predicate” registration route.
Beginning in 2022, the HSA has cease to entertain inquiries seeking confirmation of manufacturers’ classification and grouping strategy and has referred companies to their online tools and guidance documents.