Japan to Establish Digital Repository of Medical Device Safety Info. Manufacturers will be Required to Post Package Insert Information to it

The majority of medical and in-vitro devices sold in Japan will be required to post package insert information to a website maintained by the country’s Pharmaceuticals and Medical Devices Agency, in accordance with a new regulation going into effect on August 1. In line with the mandate, companies will be required to make safety, use, and risk information on devices they offer for sale in the country available on a mobile application that can be downloaded by consumers for free. Products consumers purchase directly will not be subject to the new requirement. For such products, paper inserts currently in use will suffice.

The changes, mandated by a recent revision to Japan’s Pharmaceuticals and Medical Devices Act, are designed to allow manufacturers to more easily and speedily update use and safety information to their products than they have been able to in the past. That will offer consumers stronger protections.