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Medical Device Registration System in Japan
Article 2 of Pharmaceutical and Medical Device Act (PMD Act) defines medical devices as “Equipment/instruments intended for use in the diagnosis, treatment or prevention of disease in humans or animals, or intended to affect the bodily structure and functions of humans or animals.”
With regard to a medical device regulatory application, its safety and efficacy are reviewed based on scientific data submitted to the authority. In case of new medical devices, it is required to undergo follow-up evaluation regarding their efficacy, safety and suitability in the form of post-marketing surveillance (PMS).
