PMDA has updated the available scheduling window for SaMD consultations
PMDA’s Programmed Medical Device page now states that the currently adjustable timing for face-to-face advice conducted by the Programmed Medical Device Review Office is November 2026 and later.
PMDA indicates that this availability information is expected to be updated approximately every two weeks.
Where an applicant requests a preliminary view before the meeting, the preliminary view is issued at the listed timing and the meeting is held approximately two weeks later.
This is a consultation-scheduling update, not a change to the approval review clock
The August 31 update concerns available consultation timing. It does not announce a new statutory or standard review period for SaMD marketing-authorization review.
For project teams, it should therefore be treated as a resource-capacity and planning signal.
Applicants may need general consultation before requesting scheduling
PMDA advises applicants that if they are planning face-to-face advice but have not yet completed a general consultation or related preliminary discussion, they should apply for that consultation before submitting a scheduling request.
Questions concerning whether clinical evaluation is necessary or whether planned evidence is sufficient for an approval application may be directed into the appropriate clinical-trial or other formal consultation category.
What companies can check
- Identify Japan SaMD projects that need PMDA face-to-face advice in the fourth quarter of 2026.
- Confirm whether prerequisite general consultation has already been completed.
- Add approximately two weeks where a preliminary PMDA view is requested before the meeting.
- Make sure the consultation questions on clinical evaluation, performance evidence, or pre-submission strategy are sufficiently specific.
- Keep consultation scheduling separate from the formal approval-review timeline in the project plan.
The update is small but operationally useful. For SaMD developers, consultation availability can affect the submission schedule even when the underlying approval-review framework has not changed.
Sources
- Primary official sourceプログラム医療機器 (opens in a new tab)Pharmaceuticals and Medical Devices Agency
- Supporting sourceプログラム医療機器 薬事開発総合対面助言 (opens in a new tab)Pharmaceuticals and Medical Devices Agency