Japan is way behind the US and EU for approving medical devices with AI.
In September 2020, Japan introduced the IDATEN system (improvement design with approval for timely evaluation and notice) which was designed to quickly allow partial modifications of approvals for medical devices. While only 2 products have used the IDATEN system to date, the MHLW hopes this system will be used more in the future. Generally, this system is geared toward SaMD products utilizing AI.
The main flow of this system is as follows. First, an applicant will apply for a pre-development consultation with the PMDA. This is to discuss the applicability of their product to the system. If the applicability to the system is confirmed, an application is submitted to obtain the confirmation for the change plan. As soon as the applicant has gathered the necessary data for the planned change, notification of minor change can be submitted. This system can also be applied to program medical devices.
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Ames Gross
President
Pacific Bridge Medical
Bethesda, MD
www.pacificbridgemedical.comcontact@pacificbridgemedical.com------------------------------