Japan PAL Audits performed abroad by the PMDA: What to expect and how to prepare


Instructor: Phil Smart
Product ID: 701049

  • Duration: 90 Min
This training course will concentrate on how to prepare for the audit, from language and culture to technical requirements and auditor expectations.


Due to the 2005 revisions in the Japanese Pharmaceutical Affairs Law (PAL), the PMDA - Pharmaceuticals and Medical Devices Agency - is beginning to step up its scheduling of on-site audits of foreign medical device manufacturers.

Last Recorded Date: Nov-2008


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Read Frequently Asked Questions

The decision to audit is generally risk-based, taking into consideration new submissions, device classifications, post-market events, etc. The basis of the audit is Ministry Ordinance 169, with many similarities to ISO 13485, but also with several very important differences and nuances. In order to ensure that the PMDA audit runs as smoothly as possible, it has become increasingly popular for non-Japanese manufacturers to undergo special preparation activities. This training course will concentrate on how to prepare for the audit, from language and culture to technical requirements and auditor expectations.

Areas Covered in the seminar:

  • The Foreign Manufacturer and its relationship to the MAH.
  • Pre-audit deliverables and how to present.
  • Translation of key documents.
  • PMDA auditors, their technical backgrounds and auditing techniques.
  • Schedule and planning, greetings and cultural considerations.
  • Setting the stage for a successful PMDA audit, opening & closing meetings and presentations by process owners.
  • Effective use of on-site interpreters.
  • Audit focus: What to expect during a PMDA audit - including differences to ISO 13485, documentation reviews versus facility walk-through, buildings and facilities, housekeeping, inspections and NC products, foreign matter, etc.

Who will benefit:

  • This webinar will provide valuable assistance to quality
  • Regulatory and manufacturing associates
  • whose companies sell or plan to sell their medical products in Japan

Instructor Profile:

Phil Smart, is a founding member and Regulatory Consultant of RA/QA International LLC. He serves as Consultant, Auditor and Instructor, covering medical device regulations and standards within the US, Europe, Canada and Japan. He has spent over seven years in Tokyo and is a former head of operations and medical device assessment activities for TUV in Japan. He has been a European Notified Body Lead Assessor and Monitoring Auditor for over 15 years with auditing experience in a wide range of active and non-active medical device technologies.

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