Resource Library for Medical Device Professionals

4 total results. Show all resources.

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

White Paper | 8 pages

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.download

White Paper | 6 pages

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

White Paper | 8 pages

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

White Paper | 8 pages