Revision in Japanese PAL: Measures for Safety Related to Medical Devices

One of the main revisions of the Japanese Pharmaceutical Affairs Law (PAL) that was passed in 2002 will be the re-categorization of medical devices. The Japanese medical devices classification system will be revised in the PAL to take into account the risks associated with the use of medical equipment. The official new definitions for each class of medical device will be made available in the near future.

Although the proposed re-classification may appear to be a simple reduction of the current four-class structure into three classes, the effects of the revision will be substantial. Medical devices will be re-categorized based on the amount of control required by the government to ensure patient safety in medical product distribution and use. The three new categories of medical devices will be as follows:

  • Kodo-kanri Iryo Kiki (medical equipment requiring advanced controls): This class is anticipated to correspond to Classes III and IV of the current national classification.
  • Kanri Iryo Kiki (medical equipment requiring controls): This is anticipated to correspond to Class II of the national classification.
  • Ippan Iryo Kiki (general medical equipment): This is anticipated to correspond to Class I of the national classification.