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:
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.
There's no risk when you purchase from FDAnews with our money-back guarantee. Not satisfied with your management report? Return the hard copy within 30 days (in resalable condition) and we will refund 100 percent of your purchase price (less shipping/handling). For the PDF version, you must notify FDAnews within 24 hours of receipt of purchase to receive a refund.
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