Industry Trend Analysis - Japan's New Medical Device Regulations Will Increase Market Access

摘要

The new amended Pharmaceuticals and Medical Devices (PMD) Act will improve Japan's medical device regulatory environment by increasing efficiency in regulatory processes and establishing a more reliable legal compliance system. The new regulations will shorten the time involved in pre-market evaluations and will also put a greater emphasis on emerging technologies such as Artificial Intelligence, which will increase market access and therefore support medical device market growth. Japan will continue to have the most attractive medical device regulatory environment in Asia, offering low risk to investors, although the pricing and reimbursement system in the country remains tough.