Japan's Ministry of Health, Labour and Welfare has opened a public comment period on a draft order that would ease address labelling for four product groups and add a new category of treatment software to the rules on consumer medical devices. The draft amends the enforcement regulations of the law on the quality, efficacy and safety of pharmaceuticals and medical devices. Comments close on 26 November 2026.
One address rule extended to four product groups
Under the law, pharmaceuticals, quasi-drugs, cosmetics and regenerative medicine products must show the marketing authorisation holder's address on the direct container or wrapping. Medical devices must show it on the device or its container. By regulation, that address is read as the location of the office where the general marketing compliance officer works.
Foreign manufacturers that hold an approval or certification must also appoint a party in Japan to take safety measures. That party's name and address go on the container too. For pharmaceuticals, the regulations already read the appointed holder's address as the compliance officer's office. For quasi-drugs and cosmetics, no such reading exists. For medical devices and regenerative products it exists only in part.
The draft would add the same reading for quasi-drugs, cosmetics, medical devices and regenerative medicine products. The ministry describes the aim as rationalising container labelling.
There is a three-year grace period. Products already on the market when the order takes effect, and products marketed within three years of that date, are deemed compliant if their labels meet the old rules and keep doing so.
A new category for treatment software
The second change concerns medical devices sold mainly to consumers. Devices on that list must carry usage and handling precautions in package inserts. The draft adds a classification, "disease treatment programs", to the table that sets the list. The ministry says the definition of some generic device names under the existing "disease diagnosis programs" category will change, so that they are used to assist treatment rather than for diagnosis. Those names will then fall under the new treatment category.
The ministry says the addition prepares for future generic names under the ministerial notice that designates such devices. It places the new entry in item 6 of the table because neither the classification name nor the generic names carry "home-use" wording.
Timing and how to comment
The ministry plans to promulgate the order in late December 2026, with effect from the day of promulgation. The notice gives no product counts or cost estimates.
Comments may go through the e-Gov portal, by email or by post to the ministry's Compliance and Narcotics Division. They must be in Japanese and include reasons, and the ministry says it will not reply to individual submissions. It may publish comments with names and contact details removed.