Related Experiment Video
Updated: Dec 25, 2025

Bidirectional Electrical and Optoelectronic Interfaces in Healthy and Ischemic Ex Vivo Rat Hearts
Published on: July 18, 2025
A Concept for a Japanese Regulatory Framework for Emerging Medical Devices with Frequently Modified Behavior
Nagomi Ota1, Keisuke Tachibana1, Tetsuya Kusakabe2
1Graduate School of Pharmaceutical Sciences, Osaka University, Osaka, Japan.
Abstract:
Recent progress in the Internet of Things and artificial intelligence has made it possible to utilize the vast quantity of personal health records, clinical data, and scientific findings for prognosis, diagnosis, and therapy. These innovative technologies provide new possibilities with the development of medical devices (MDs), whose behaviors can be continuously modified. A novel regulatory framework covering these MDs is now under discussion in Japan. In this review, we introduce the regulatory initiative for MDs and the importance of a paradigm shift from regulation to innovation regarding MDs.
More Related Videos
08:42The DREAM Implant: A Lightweight, Modular, and Cost-Effective Implant System for Chronic Electrophysiology in Head-Fixed and Freely Behaving Mice
Published on: July 26, 2024
11:54Real-Time Proxy-Control of Re-Parameterized Peripheral Signals using a Close-Loop Interface
Published on: May 8, 2021
Related Concept Videos
Drug Regulation
Global Regulatory Systems
Drug Control Governance: Regulatory Bodies and Their Impact
Clinically Relevant Drug Product Specifications: Methods of Establishment
Drug Administration and Therapy Phases: Overview
The pharmaceutical phase focuses on leveraging the physicochemical properties of the drug to design and manufacture an effective product. Variants include orally administered tablets or capsules, topical creams or ointments, and parenteral-delivery solutions or emulsions.
The pharmacokinetic phase...
Pharmacovigilance
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...