Surviving a Japanese Medical Device Inspection

$357.00
July 2009
978-1-60004-058-0
198
Also Available:

Don’t wait until Japanese inspectors are reviewing your facility to find out how their priorities differ from those in the U.S and EU …

Be Prepared with the Comprehensive Guide to
Surviving a PMDA Inspection

Until recently, you didn’t have to worry about visits from the Pharmaceuticals and Medical Devices Agency (PMDA), Japan’s version of the FDA. Then the country changed the rules, requiring its regulatory body to inspect medical device manufacturers who sell their products there. Now, they routinely inspect facilities, and you have a whole new set of regulations to follow.

Like most countries, Japan has its own GMP guidances, and its inspectors follow a unique set of procedures and documentation requirements. Plus, there are subtleties in language and behavior than can make the difference between passing and failing an inspection.

And failing means seeing your product banned in a nation that makes up 10 percent of the global medical device market …

Surviving a Japanese Medical Device Inspection is the one management report that will tell you exactly what to expect when Japanese inspectors arrive, how to prepare and manage the inspection process and ensure that inspectors leave happy and confident in your facility's compliance.

Place your order today and learn:

  • What permits and licenses you need to market a device in Japan
  • The five key differences between PMDA and FDA inspections
  • How the PMDA is structured and how it trains investigators
  • What unique documents and systems PMDA investigators focus on
  • How your inspectional readiness strategies for FDA and EU inspections stack up against PMDA inspection
  • The specific violations that can keep your product off the market in Japan

Buy Now!
Ensure your medical device products are part of this lucrative market with Surviving a Japanese Medical Device Inspection. Priced at just $357, this vital management report is available in PDF and print format.

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