UL Asia
Asia Issue 13 (Spring, 2005)   UL
On the Mark On the Mark UL
Recent Amendment in Japan's Pharmaceutical Affairs Law (PAL) for Medical Devices

In July 2002, the Japanese House of Representatives passed the amended Pharmaceutical Affairs Law (PAL), which is applicable to all the medical devices, drugs, quasi-drugs and cosmetics entering the Japan market. The amended PAL will go into effect on April 1, 2005, serving the purposes of:

  • Enhancing the safety measures of medical devices being sold in the Japan's market.
  • Strengthening the post-marketing safety measures of medical devices.
  • Fortifying medical devices' review system for approval and license while taking international conformity into account.

PAL Before Revisions
Under the current PAL, it is assumed that the legal license holders of any medical devices have their own manufacturing facilities. For each item of product, the legal license holder has to apply for a license to be a recognized manufacturer and an approval of the medical device he manufactures. The license and approval system under the existing PAL is said to have the following inadequacies:

  • Post-marketing safety measures for controlling medicaldevices are insufficient.
  • Owing to the differences in certification systems, the market practices of Japan are not aligned with those in the United States and Europe.
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In this issue
Get ready for EU's 2006 RoHS directive with UL's New Restricted Substances Compliance Solutions (RSCS)
UL 508 - The UL Safety Standard for Industrial Control Equipment
Recent Amendment in Japan's Pharmaceutical Affairs Law (PAL) for Medical Devices
Network Access License (NAL) Approval
Divisions of GE Medical in India to be Certified to ISO 14001:2004
UL University Seminar Schedule
News Bites
Standards Update
Past Issues
Issue 12 (Winter 2004)
Issue 11 (Fall 2004)
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