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In this white paper, we discuss quality system assessment under Japan's new regulation, the Pharmaceutical and Medical Device Act.
In this white paper, we discuss how to register a medical device for sale in Japan as a foreign company and requirements to be aware of.
Determining the Japanese clinical data requirements for your device can be challenging. This paper explains PMDA clinical requirements.
In this white paper, we discuss when and how to notify Japan's PMDA about design changes to your device.
In this white paper, we discuss the steps you should follow to achieve MDSAP certification.