Audio Conference

Japan's Revised PAL: What Device Companies Need to Know Steve McRoberts Global Principal Engineer Medical Regulatory Programs UL International (UK) Ltd. Purchase recording - US$199

Purchase recording of this Audio Conference

In 2002, the Japanese Ministry of Health, Labour and Welfare announced sweeping changes to its Pharmaceutical Affairs Law and the regulations governing the sale of medical devices in Japan. Japan represents a 10% share of the global medical device market, and it is vital that device manufacturers have a thorough understanding of the revised PAL if they wish to gain legal market entry.

This presentation will give an introductory overview of the structure of the Japanese regulations, and highlight the main requirements device companies must meet in exporting their products to Japan.

This audio conference will cover:

• Device classification, routes to conformity, and identifying standards
• How to meet essential principles
• The role of the third party
• The requirements for quality systems
• The role of the Marketing Authorization holder

About the speaker:

Steve McRoberts is UL's Global Principal Engineer for Medical Regulatory Programs, and over the past two years he has led UL's successful efforts to attain accreditation in Japan under the PAL program. His responsibilities include the program development and technical expert for UL's medical regulatory programs including FDA 510(k) and Inspection Programs, CMDCAS (Canada) and European MDD and IVDD Notified Bodies. Steve joined UL in 1999 has a Medical Device Specialist with UL International (UK) Ltd.

Before joining UL, Steve was a certification engineer with CSA in Vancouver, Canada. In 1999 Steve became interested in the US and Canadian MRAs and became a recognized FDA Reviewer and CMDCAS specialist. Steve earned his Bachelor of Science degree with Honours in Optoelectronic Engineering from Heriot-Watt University, Scotland, is registered as a Chartered Scientist, Chartered Physicist and Member of the Institute of Physics.

Who should attend:

• Regulatory affairs managers
• Quality managers
• Export sales managers
• Senior management

This audio conference is classified as General Interest.

Purchase recording US$199

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