The Pharmaceutical and Medical Device Act (PMD Act) in Japan was amended in December 2019. This amendment further improves patient access to innovative drugs and medical devices in Japan, and also post-marketing safety measures have been further strengthened. This session can provide an overview of Japanese regulations through explanations of the purpose and key points of the amendment of the PMD Act. This session also provides an understanding of PMDA’s approach to the high-profile areas such as reviewing of innovative medical devices like AI based devices. Through this session, we will discuss a strategic approach toward the rapid delivery of innovative medical devices to Japan, the world's second largest market.
Learning Objectives:
Explain key points of the amendment of PMD Act and Japan's regulations for medical devices.
Discuss necessary matters for early delivery of products to Japan.
