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

$327.00
Held May 28, 2009

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 …

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 procedure. 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.
Order now for 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

Don’t risk getting shut out of this lucrative market.

This audio CD/Transcript is a must for anyone who is currently selling or is considering selling their medical devices in Japan, including:
  • Compliance officers
  • QA/QS personnel
  • Senior management
  • Manufacturing directors
  • General/corporate counsel
  • Regulatory/legislative affairs professionals

Phone: toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600

David Dills provides independent consultative services in various capacities from premarketing to postmarketing within the technical, quality, regulatory affairs and compliance arenas to pharmaceutical, Class I/II/III medical devices, in vitro diagnostics and biologics/biotech companies with an emphasis on establishing sustainable compliance systems. David has served as director of publications, Regulatory & Compliance, for the Institute of Validation Technology. Through his work, David has been affiliated with the life sciences industry for more than 19 years with increasing responsibilities in QA, quality engineering, validation, RA/compliance and corporate/operations management. He was previously employed on behalf of globally recognized device manufacturers and service providers in conjunction with marketing and business development responsibilities.

David’s areas of interest and expertise include executing process validation, supplier qualification, training, internal/due diligence audits, policy/procedure development, PM, risk management/assessment, ISO 9001/13485/14971, MDD 93/42/EEC, CE Marking, remediation, GxPs, SW validation/IT network, MDR/AE/product complaints, design/change control, CAPA, PMA, IDE, 510(k), NDA and e-CTD/CMCs submissions, interfacing with international regulatory bodies, QSIT and PAI inspections, sample accountability, and other related functions and tasks. David’s academic degrees include Environmental Science and Biology. He currently serves as advisor for the ASQ’s Section 1506 and as a former chair and co-chair. He is an active member of the Biomedical Division, RAPS, PDA, ISPE and other industry working groups.

Order now!