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Resource Library for Medical Device Professionals

5 total results. Show all resources.

Japan's New QMS Conformity Assessment System

In this white paper, we discuss quality system assessment under Japan's new regulation, the Pharmaceutical and Medical Device Act.

8 pages
Oct 12, 2016

Japan's Pharmaceutical and Medical Devices Act (PMD 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.

6 pages
Oct 10, 2016

Medical Device Change Applications in Japan

In this white paper, we discuss when and how to notify Japan's PMDA about design changes to your device.

15 pages
Jun 21, 2018

Clinical Data Requirements in Japan

Determining the Japanese clinical data requirements for your device can be challenging. This paper explains PMDA clinical requirements.

8 pages
Jul 8, 2016

Transitioning to Medical Device Single Audit Program (MDSAP) Compliance

In this white paper, we discuss the steps you should follow to achieve MDSAP certification.

8 pages
Jan 15, 2018