LifeTech 2020 Tutorial Session

Abstract

To provide safe and effective medical devices for patients in a timely manner, understanding the regulatory framework is a key element at an early stage of development. Medical devices in Japan are under the regulation of the Pharmaceuticals, Medical Devices, and Other Therapeutic Products Act (PMD Act). Japan has proactively incorporated Global Harmonization Task Force (GHTF) documents into its regulations to achieve regulatory convergence. The purpose of GHTF is to encourage convergence in regulatory requirements, practices and systems across the world. Currently, the International Medical Device Regulatory Forum (IMDRF) is continuing the work of GHTF and the current members are Australia, Brazil, Canada, China, the Russian Federation, the European Union, the United States, Singapore, South Korea and Japan. In this session, we will introduce the basic regulatory framework in Japan by comparing with GHTF documents especially for the premarketing review stage and how to use the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC) standards in the regulation. Furthermore, revised PMD Act on November 2019 regarding medical devices will be introduced.