ABSTRACT
Now that the previous chapter has briefly sketched out the main political, bureaucratic, and social forces in existence prior to PAL in 2005, this chapter turns to PAL and explores why medical device regulation was reorganized and how it institutionalized a number of formal building blocks of medical technology regulation. It is difficult to avoid highly complex technical and legal details when commenting on the PAL as policy and as law. Not only does the PAL touch on the organization of MHLW, which sits at the apex of regulatory processes and the public health insurance program, but PAL also impacts the entire community of device makers, the distribution and supply system in Japan, and the collection process for scientific input used in decision-making. The final section briefly introduces the Pharmaceutical and Medical Device Agency (PMDA) as an example of public-sector reform designed to achieve three objectives: to modernize medical device regulation, to improve the structural conditions for clinical research, and to enhance access to much-needed specialized treatments and care in Japan.
