Japanese Medical Device Inspections: How to Survive a Visit From the PMDA

Venue: Virtual

Location: Virtual, United States

Event Date/Time: May 28, 2009
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Until recently, you could sell your products in Japan without worrying about an inspection from the country’s Pharmaceuticals and Medical Devices Agency (PMDA). That’s history. Currently, the PMDA is required to conduct inspections of foreign manufacturers. After several years of phasing in the practice, PMDA investigators are now out in full force — and you’d better be ready!

Do you know what PMDA investigators look for first? Or how the process differs from the FDA’s? Do you need your own translator?

Knowing the answers to these and many more questions may mean the difference between getting a piece of a $20 billion (and growing) market or being shut out.

Read on …

In this 90-minute webinar, device industry consultant David Dills — fresh from helping a client successfully pass a PMDA inspection — will give you the nuts and bolts of getting through this complex and difficult procedures. From the necessary preparation process to special considerations in managing the inspection, you’ll get step-by-step direction from someone who’s been there and back!

In addition, David will go over Japan’s regulatory system, what documents and systems the PMDA looks for and why devicemakers should use the Summary Technical Document format for their regulatory submissions.

Sign up your entire team to listen in and discover:

* The permits and licenses you’ll need to market a device (including a shonin and kyoka)
* 5 key areas in which a PMDA inspection differs from the FDA's
* How the PMDA is structured and how it is training its investigators
* The unique documents and systems the PMDA investigators focus on
* How your inspectional readiness strategies for FDA/EMEA inspections stack up to a PMDA inspection
* Which violations can keep your product off the market in Japan
* What special considerations you should take into account when dealing with the PMDA — e.g. do you need your own translator?
* How using the Summary Technical Document format for submissions can help get your device to Japan’s market without issues