Japanese Pharmaceutical Affairs Law (PAL) Revisions: Labeling Requirements for Medical Devices

The Pharmaceutical Affairs Law (PAL) that passed legislation in Japan last year included four major revisions that are noteworthy to foreign medical device manufacturers:

  1. Revision of the measures for safety related to medical devices,
  2. Enhancement of the measures for safety after marketing, and revision of the approval and licensing system,
  3. Revision of the evaluation system for approval, and
  4. Measures for securing safety related to the biologically derived products.

Besides these revisions, labeling requirements for medical devices will also be revised. Although the details of this change have not been officially announced, some additional information has been made known. The name of the medical device, manufacturer’s serial number or lot number, and manufacturing code will be required to be affixed to the device or its immediate packaging in the future. This is in addition to the direct presentation of the name of the distributor and expiration date on the medical equipment that is currently required.

These revisions were passed in April 2002; however, they are not scheduled for implementation until April 2005, except for regulations related to biologically derived products, which will be implemented between April and July 2003.