ABSTRACT
This chapter will focus on the Ministry of Health, Labor, and Welfare (MHLW), the Pharmaceuticals and Medical Device Agency (PMDA), and the organization of regulatory responsibilities between them. The chapter examines the policy instruments at the disposal of MHLW and PMDA. To understand how they discharge their responsibilities and apply these tools, the chapter primarily draws on field data and the personal views and experiences of the regulators and other informants. For understanding the role of the Ministry of Health, it is useful to distinguish between two responsibilities: its control over medical technology regulation and its control over reimbursement and prices. The second part will look more closely at bureaucratic processes and operations, the distribution system for medical technologies in Japan, and the various advisory committees that recommend strategic and tactical decisions for ultimate decision-making by MHLW.
