Japan Changes PAL and PMDA To Enhance Medical Device Innovation
Japan is dramatically revising its Pharmaceutical Affairs Law (PAL) in such a way that will positively change how medical devices are marketed and developed within its borders. Specifically, the decision was made to recognize the different development cycles associated with drugs and devices, and create a regulatory separation between the two classes of therapy in order to improve how the each are handled at the administrative level. The changes went into effect November 25, 2014.
There are several important aspects of the new PAL, and a number of these have drawn their inspiration from global standards. A clear example of this influence is the move to regulate medical software as a separate class of product, rather than continue to view software and hardware as inextricably bound together. This opens the door for the increased penetration of mobile health apps in Japan that do not have a hardware component beyond the phone or tablet on which they are running.
Medical device manufacturers operating with in Japan, as well as those exporting to the country, will now undergo a registration process rather than a licensing process, which promises to reduce the administrative overhead associated with doing business in the country (one of the chief aims of the PAL revision). Third-party certification of medical devices will be expanded to medium-risk Class III products, which further reduces bureaucratic burden by allowing the Pharmaceutical and Medical Device Agency (PMDA) to focus on higher risk products - a move that should help to cut the Agency's notorious lag time between application and final review by as much as 50 percent.
Japan's decision to streamline PMDA operations and PAL regulations is a direct result of the SAKIGAKE initiative that was announced in June of this year. SAKIGAKE aims to make Japan a more inviting place for pioneering medical devices, in a bid to create an environment where the country can be seen as a leader in medical innovation, research, and development.