Japan medical device regulatory resources

PMDA states plainly that it does not review the notification (提出された届書については審査を行いません) — it is filed on the notifier’s own responsibility, so there is no decision period to wait out

Art. 23-2-12(1) requires only that the notification be filed in advance of marketing; the product may be placed on the market from that point

No fee is payable for the notification, unlike the certification and approval routes

The manufacturer/marketer licence (製造販売業許可, third class or above) from the prefecture and the manufacturing-site registrations must already be in place before the notification is filed — those are the real lead time

Any change to a notified item must be filed within 30 days of the change date; a late filing needs a written explanation of delay to the PMDA Chief Executive

A Class I device with no matching JMDN general name, or one that is genuinely new, falls out of this route and into an approval application instead

Zero is recorded because the government sets no clock here, not because certification is instant: Enforcement Regulation Art. 129(3)(i) makes each registered certification body state its own standard processing period in the business rules it files for MHLW approval, so the period is per-body and there is no national figure to publish

MHLW notice 医薬機審発0306第1号 (6 March 2026) is what spells out that requirement for the business rules

Example of what an approved set of business rules actually commits to: SGS Japan’s 実施規程 gives up to 2 months from receipt to the start of review, review effort measured in assessor-days (1.5-5.0 for the standards-conformity assessment), and 15 business days for technical review plus issue of the certificate

This is the route for 指定高度管理医療機器等 — Class II and the designated part of Class III for which MHLW has issued a certification standard (認証基準)

The route is not elective. If a certification standard exists and the device meets it, certification is mandatory; if no standard exists or the device falls outside it, the device goes to PMDA approval instead and picks up the application-category target below

A QMS conformity investigation must be applied for to the same certification body alongside the certification application (Art. 23-2-23(3))

PMDA publishes this target by application type, not by risk class; priority-review new devices have a 9-month target

The figure comes from MHLW’s 2008 医療機器の審査迅速化アクションプログラム, and PMDA prints a caveat next to it: it is a guide to the review period, not a promise that approval will land inside it

PMDA separately commits to a mid-term-plan target of 14 months at the 80th percentile for ordinary new devices and 10 months at the 80th percentile for priority items — a longer number than the 12-month guide because it is a tile value rather than a midpoint

Observed process split (25th–median–75th percentile of total elapsed time, PMDA standard-process timeline): 1.2-1.4-1.7 months application to product briefing, 1.8-3.0-3.7 to the main round of questions, 3.7-4.8-5.3 through the answer cycles, 2.3-2.8-3.6 for expert consultation, 0.2-0.2-0.9 from review report to approval

Items that must go to the Pharmaceutical Affairs and Food Sanitation Council device committee run 11.0-12.0-12.0 months in total; items that skip committee run 3.7-7.1-10.1

Reliability and QMS investigations run in parallel with the technical review rather than after it

PMDA has reported a review lag against the United States of zero for new devices every year since FY2013; the remaining gap Japan measures is the development lag, which is when companies choose to file

PMDA publishes this target by application type, not by risk class

Mid-term-plan target is stated differently again: 10 months at the 60th percentile

Observed process split (25th–median–75th percentile): 0.2-0.8-1.6 months to product briefing, 0.5-3.1-5.7 to the main questions, 2.8-3.4-4.0 through answer cycles, 1.9-2.1-2.6 for expert consultation, 0.1-0.2-0.2 from review report to approval, for 6.5-8.4-8.8 in total