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.
For medical devices that constantly change their performance after marketing, such as medical devices that utilize AI, and medical devices that use real-world data (RWD: clinical data) collected after marketing for improvement, the system is expected to be a useful option.
Mr. Niimura of the MHLW said after the approval of a SaMD with AI, the AI may get smarter and smarter. For example, if the detection rate is 50% initially, it is expressed as 50% on the approval document. Even if it is 60% or 70%, there is no particular legal problem, but it is not allowed to sell such product saying 60% or 70%. So, when it is 60%, 70%, or more we think you can use the IDATEN system and submit a notification if there is no problem within 60 days. As Japan accepts more AI medical devices this should hasten the time for approval.