View Cart  

Japanese Medical Device Inspection Guide

December 2008
Also Available:

Japanese Medical Device Inspection Guide, the working English translations of Japanese GMP regulations and guidances. This 120-page manual is all you need to ensure your facility can handle the scrutiny of a PMDA inspection.

Place your order today and get:

  • Which quality subsystems will always be inspected in a PMDA inspection and which may be omitted
  • Factors used in the PMDA risk assessment that establish which companies will be inspected
  • Requirements for all quality systems under Japan's GMPs
  • Facility requirements for medical device manufacturers
  • Timelines for Japanese medical device GMP inspections

Japanese Medical Device Inspection Guide will help you meet Japan’s GMP requirements and ensure your access to that lucrative market. The official documents that have been translated into English include:

  • The Ministerial Ordinance on Standards for Quality Assurance for Drugs, Quasi-drugs, Cosmetics and Medical Devices
  • The Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Medical Devices and In-Vitro Diagnostic Reagents
  • Regulations for Buildings and Facilities of Pharmacies
  • The Explanation of Application for Accreditation of Foreign Manufacturers
  • Quality Management System Inspection of Medical Devices and In-Vitro Diagnostics in Japan

Buy Now!
Don’t be caught off-guard when inspectors from the PMDA show up at your facility. Japanese Medical Device Inspection Guide is just $297.

Interested in purchasing more than one print copy?
Significant volume discounts are available for ordering three or more copies of the same book. You must order them at the same time and provide a single payment to take advantage of the discount. Order below by clicking submit and then change your quantity in the shopping cart. The discount will be calculated automatically.

3-4 copies – 10%
5-6 copies – 15%
7-9 copies – 20%
10+ copies – 25%

Call (888) 838-5578 in the U.S. or +1 (703) 538-7600 globally with any questions.

Interested in Electronic Multi-user Access?
Save money with a license agreement allowing significant numbers of users access to an electronic version of this book. For multi-user access to multiple titles, FDAnews offers the Electronic Books Library – a personalized collection of FDAnews publications that is fully searchable.

For more information please contact Customer Service:
Phone:  +1 (703) 538-7600 or toll free (888) 838-5578