Charting Important Change in Japan’s Device Review Regulations

Ever since the new Pharmaceutical Affairs Law (PAL)—which applies not only to pharmaceutical manufacturers but also to medical device manufacturers—was implemented in April 2005, Japan’s regulatory system has drastically changed. Looking back at the past 16 months, this column reviews the impact of this PAL from the viewpoint of a foreign medical device manufacturer.

The basic concept of the new PAL is to shift the weight from the manufacturing service to the field sales, similar to how the United States and Europe operate. Japan’s regulatory system consists of two major systems: one pertaining to the business license granted to a company, called “KYOKA,” and one related to product approvals, called “SHONIN.” Both systems have changed significantly since the introduction of the latest PAL.
    

Yoshio Mitsumori is the president and CEO for Tokyo-based ADMIS, a consultant specializing in the medical device industry. He has more than 25 years of experience in the medical industry, including positions with the Itochu Corp., U.S. Surgical, National Medical Enterprises and Century Medical. A member of RAPS, he has spoken at many industry events and worked extensively in international trade of medical products and technologies. He can be reached at [email protected].