SaMD Regulations in Japan: a Quick Look.
SaMD in Japan
There is has been a lot of work going on at the PMDA and the MHLW with regard to SaMD over the past few years and right into 2025. Readers will be aware of the SaMD office at the PMDA and that the 'Dash for SaMD' project is ongoing. This is part of an over all beefing up of the PMDA's approval capacity, and its international outreach.
Several hundred SaMD devices have received approval by the PMDA so far and definitely more are on the way.
The main thrust of this activity is that the PMDA is very keen to reduce approval times so that companies can introduce the most up to date SaMD devices and make them available in the market, while maintaining safety. One aspect of this is to quickly categorize programs such that they fall into a Class II or Class III medical device classification and require approval or registration. Software programs that fall outside of Class II and III will be outside of PMDA regulations.
Almost all home use software and software considered Class I devices are outside PMDA approval requirements. For example: Software for heath management, Software for education, Software for supporting hospital operation, and Software corresponding to Class I would not be subject to a PMDA approval process.
That said, Class II or III devices include : (numbers in parentheses indicate how many have been approved as of July 2024)
For Home Use:
Program for home use diagnostic assistance (2)
For Diagnosis and Examination:
Program for computer assisted Imaging diagnostics (312) Program for computer assisted diagnostics other than imaging (79),Program for gene mutation analysis (10)
For Treatment:
Program for therapy planning support (59).Program for surgery support (1)Therapy support program (7) Programmer for active implantable
device (3)
Two Step Approval Process:
To speed up approval process, if a new SaMD Device can show efficacy, it can received a First-Step approval. While in use, if Clinical Benefit can be established, then a Second-Step approval is possible.
Machine Learning and AI:
No discussion of Medical Devices is complete without AI and Machine Learning. More space than this blog post can provide is needed, but suffice it to say that once on the market, a Post-Approval Change Management Protocol (PACMP/IDATEN) for MDs is in place which will allow for performance improvement after an AI or Machine Learning Device has entered the market, without having to go back to the beginning of the approval process. Much more to be said on this in future blog posts.
Market Strategy:
Companies which are planning to bring a SaMD to Japan really need to consider how they are planning to enter the market with regards to the status as a Medical Device as this will make an important difference to your market entry strategy. In particular how the program is distributed, and what partners will be involved in Japan.
Be sure to contact Parkdale Group for more information.
We are a Canadian owned and operated company, based in Japan.
contact: info@parkdale-group.co.jp
Source:Regulations for QMS and SaMD
in Japan
7th India-Japan Medical Products Regulatory Symposium
July 10th, 2024
Principal Reviewer, Madoka MURAKAMI, Ph.D.
https://www.pmda.go.jp/files/000269712.pdf
This material collected from official sources at the PMDA. This blog post is Copyright, Parkdale Group Inc. 2025.