PMDA Approach to Artificial Intelligence (AI) based Medical Devices


The Pharmaceutical and Medical Device Agency (PMDA), has been constantly adapting to identify emerging technologies such as AI based medical devices to improve the efficiency of review process and expedite development of novel medical products to benefit patients.

In order to meet AI based medical devices regulatory assessment needs, PMDA works with sub-committees under the Science Board to obtain clarifications on review points for regulated products that cannot be easily assessed using existing systems.

PMDA AI Medical Device and systems characteristics:

PMDA characterizes AI Medical Devices and Systems based on four parameters including Plasticity, Predictability, Quality of Data and Degree of Autonomy. PMDA further works with a framework where it receives Review Points from the Science Board, Academia and inputs from other stakeholders to assess the regulate the devices.

The review points include;

  • Ensuring safety and effectiveness of the devices that adapt and change through learning by approving devices within specific acceptable ranges that do not affect the clinical relevance of device. The range is supported by rationale and validation test methods.
  • Control strategy for include in justification for post market adaptability and learning of device
  • Defining device life-cycle management including data, performance testing and control and management of any deviations from its clinically required specifications
  • The quality of data must be of high quality that meets the clinical criteria
  • Finally, the device must provide appropriate information for users to use the device appropriately, provide relevant safety and efficacy data, operating procedures of AI device, data sets and measurement of data quality, any limitations on device and performance testing range


For AI based device manufacturers, PMDA offers consultation and validation of regulatory approach.

GRP AI Expertise in Japan:

GRP has experience with AI based medical devices and can facilitate consultation with PMDA through registration, testing of device in Japan.


case studies:

Registration of Software as Device in Japan and Australia

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