Japan’s new regs
This article was originally published in The Gray Sheet
Executive Summary
All medical devices must conform to new labeling requirements under the fledgling Pharmaceuticals Affairs Law (PAL) policies, according to Pacific Bridge Medical (PBM), a medical consulting firm for Asian companies. On the product insert, the medical device classification must be listed, as well as the address of the firm's marketing authorization holder. PAL, which became effective April 1, mandates that firms name in-country representatives (1"The Gray Sheet" June 20, 2005, p. 26). Further, all devices manufactured overseas should provide the manufacturing site location. The Ministry of Health, Labour & Welfare "highly recommends" that companies complete the revisions to their product labels by March 31, 2006, PBM says...