ABSTRACT

The Japanese medical device market is the second largest single-country market in the world (estimated value between U.S. $18 and 23 billion.1, 2 It is also, arguably, the most cumbersome, conservative, restrictive, and stringently regulated system when compared to those of other major developed countries. Although the Japanese medical device market has grown significantly over the past 20 years due to improved health awareness and higher consumer expectations for health care, this growth has been slowed recently by a sluggish economy, a complicated regulatory system, and a medical device approval process that hinders new product introduction, improvements, and timely distribution. Realizing the potential these factors play in the overall economy of Japan, the Ministry of International Trade and Industry (MITI) targeted the medical device industry in the late 1990s for enhanced competitiveness in the new century, offering financial assistance to enhance collaboration among the Japanese government, business, and academia.3 Consequently, the regulatory system for medical devices, medical equipment, pharmaceuticals, and cosmetics has been in a state of flux for the past decade.4-7

II. THE JAPANESE MEDICAL DEVICE REGULATORY SYSTEM

Japan’s Ministry of Health and Welfare (MHW) began reorganization efforts in 1997 with the dismantling of the Pharmaceutical Affairs Bureau (PAB), which was suffering from allegations of misconduct and conflicts of interest.5,6,8 The agency sought to separate its regulatory and promotional activities: the newly established Pharmaceutical and Medical Safety Bureau (PMSB) was now tasked with assuring safety, efficient product approval, and postmarket surveillance of all drugs, cosmetics, and medical devices, while the Ministry’s Health Policy Bureau (HPB) was charged with the enforcement of laws concerning the production and distribution of medical products and with representing companies’ interests regarding product promotion, pricing, and reimbursement.5,8

In January 2001 the MHW merged with the Ministry of Labor thereby creating the Ministry of Health, Labor and Welfare (MHLW). The “Agency” is responsible for public health, social welfare, social security, improving labor conditions, and regulating medical

devices and drugs through the implementation of the Pharmaceutical Affairs Law (PAL).9 The objective of the PAL is to ensure the quality, efficacy, and safety of pharmaceuticals, quasi-drugs (lyaku-bugaihin), cosmetics, medical devices, veterinary drugs, veterinary quasi-drugs, and veterinary medical devices while promoting product research and development.10 Safety and efficacy are primarily regulated through an approval and licensing system. PAL also details requirements for companies that manufacture or import medical devices for sale in Japan including building structural standards, education and work experience requirements for personnel, advertising, facility inspections, and reporting.9,11

Within PMSB, the Evaluation and Licensing Division evaluates drugs and medical devices, issues manufacturing and import licenses and approvals, rules on Japanese Pharmacopoeia, and designates orphan drugs and devices, whereas the Safety Division reviews the safety of medical products and sets policy regarding the safety of drugs, quasi-drugs, cosmetics, medical equipment, and devices. However, most activities related to the evaluation and registration of drugs and devices have been transferred to the Pharmaceuticals and Medical Devices Evaluation Center (PMDEC), which is part of the National Institute of Health Sciences (NIHS) and is separate administratively from the MHLW. The evaluation center scientifically reviews medical products, conducting evaluations ranging from clinical studies to approval reviews as well as postmarketing assessments.