PMDA overview of the review systems for innovative medical devices in Japan
£35.00
Unlock essential insights into Japan’s PMDA review systems to streamline the approval process for innovative medical devices and accelerate market access
English
Medical devices come in many different shapes and forms, and they differ from pharmaceuticals in that they often undergo repeated improvements and modifications even after they are placed on the market. This characteristic is particularly noticeable in Software as a Medical Device, which is often upgraded post-market. The performance of medical devices that use artificial intelligence is also expected to change constantly. Establishing review processes for the approval of medical devices that are sensitive to this characteristic, to ensure the quality, efficacy, and safety of products, while assuring access for the medical front lines to innovative, safe and effective medical products as quickly as possible is one of the most significant roles of the Pharmaceuticals and Medical Devices Agency (PMDA). The ‘Amended Pharmaceuticals and Medical Devices Act’ was promulgated in December 2019 and is being enforced stepwise since September 2020. Predictability of medical device approval reviews has been improved further as a result of several newly enforced systems, which are outlined in this article by Dr Tetsuya Kusakabe of the PMDA.
Specification: 5 pages plus covers, in English, supplied by email as a PDF.
This article has been published in the August 2024 issue of the Journal of Medical Device Regulation.
