A Guide to Best Practices for Businesses Considering International Expansion
This document compiles challenges and countermeasures based on the results of various developers’ activities, with the aim of promoting and facilitating overseas expansion. It has been compiled as a public resource for companies seeking to expand overseas.
Evaluation Materials for Overseas Expansion
This document compiles information on clinical evaluation procedures and key considerations for robotic care devices, with the aim of promoting their global adoption. It also outlines the procedures for obtaining CE marking—a requirement for sales in Europe—as well as the relevant evaluation methods.
- Clinical Evaluation Guidance for Overseas Expansion for Developers of Robotic Care Devices (March 2024)
- Guidance on Clinical Evaluation for Companies Expanding Overseas: Supplementary Materials (March 2024)
- CE Marking Procedure Manual (Assessment Framework, Assessment Methods, etc.)
- Concept Implementation Verification Handbook
Information on Key Countries for International Expansion
This report examines the current state of the long-term care market in various countries around the world and summarizes trends and future prospects for robotic care devices.
- Preliminary Survey Report on Support for the Overseas Expansion of Home-Use Robotic Care Devices (March 2023)
- Report on Overseas Research Related to the Development and Standardization of Robotic Care Equipment (March 2020)
- Overseas Survey Report on the Development and Standardization of Robotic Care Equipment <Summary Version> (March 2020)