Japan: Proposed Bill May Speed Registration for Class III Medical Devices

Japan’s health ministry has drafted a bill that could speed up the approval process for some medical devices in Japan. The bill has not gone before the Diet, but ministry officials say that they will submit their bill before the current Diet session ends.

In Japan, medical devices are classified based on their levels of risk. Class IV devices pose the highest risk and Class I devices pose the lowest risk. Japan’s Pharmaceutical Affairs Law currently requires that Class IV medical devices (such as pacemakers) and Class III medical devices (such as ventilators) be examined by the government’s Pharmaceuticals and Medical Devices Agency (PMDA) before they are approved.

The proposed bill would allow private accreditation organizations (i.e. notified bodies) to examine some Class III devices for approval. These products might include kidney dialysis machines and generic dental implant products.

The new law would greatly shorten time needed for the registration of some Class III medical devices, if it goes into effect. According to Japan’s Yomiuri Shimbun newspaper, an estimated 50 percent of Class III devices would be eligible for the new process.

Currently, only Class II medical devices are examined by private accreditation organizations in Japan.