Examples of permitted listings
Note: All listings and products must comply with all laws and regulations.
Following products that have the Pharmaceutical and Medical Device Law(*) and other laws
and regulations, administrative interpretations and guidelines (“Laws”)-required
labeling and are not otherwise restricted from selling or advertising under the Laws and
all the Amazon policies.
General medical devices
Controlled medical devices (Including
specially controlled medical devices.)
Highly controlled medical devices
(*) Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices,
Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics (PMD
Act) of Japan (Act No. 145 of 1960, as amended)
In addition to approval for products, sellers who intend to sell highly controlled
medical devices or specific maintenance management medical devices need to get
permission from the prefectural governor of the location, and sellers who intend to sell
controlled medical devices (excluding specific maintenance management medical devices)
need to notify the prefectural governor of the location. For more information, please
see the following link.
Tokyo Metro Bureau of Social Welfare and Public Health: "About medical device sales
business and lending business"
In Amazon, there is a prescribed procedure to sell medical devices. For more
information, please see the following link:
Guidelines for Selling Medical Devices (for Marketplace Merchants)
Examples of prohibited listings
Unapproved Medical Devices
Products to be used for medical or
equivalent practices on the human body, but that are not approved as medical
devices (i.e. Unapproved Medical Devices) in Japan (for example, mole removal
cream or unapproved laser epilators)
Other medical devices which are not
allowed to advertise or sell in Japan
MHLW (Ministry of Health, Labour and
Welfare)：Information of health damage and unapproved drugs
Products that require a prescription or a
medical professional's supervision or direction for their purchase and use by laws or
notifications from regulatory agencies. For listing contact lenses, please refer to
the Listing Guideline of Drugstore.
products from their containers or encapsulations and splitting them into multiple
packages for sale is prohibited.
Unauthorized imported products
imported products to a buyer or adopting a similar method for listing products (a
seller who doesn’t have a marketing license for medical devices in Japan receives
orders and another seller outside of Japan ships products to a buyer) is
prohibited. For more information, please see the following link (Japanese):
Prohibited imports by customs (Japanese):
Products intended to defeat a drug test,
such as urine additives and synthetic urine.
Products that are adulterated, misbranded
Products that have been the subject of a
prior US regulatory action, such as:
Food and Drug Administration (FDA)
warning letters, safety alerts, or recalls
Drug Enforcement Administration (DEA)
Federal Trade Commission (FTC) orders
Products that are unapproved for
advertisement, use or sale by the MHLW or any or the other regulatory agencies.
Products and products that contain
ingredients that the MHLW or any other regulatory agencies have determined present an
unreasonable description of injury or illness, or are otherwise unsafe.
Listings claiming that a product is
intended to be used for the diagnosis, cure, mitigation, treatment or prevention of
disease in humans or animals unless the claim is approved by laws, or the MHLW or any
other regulatory agencies.
Products that contain controlled substances
that are not allowed to be advertised or sold pursuant to laws or regulations.
Products that have passed their expiration
dates (used-by date or period of durability).
Opened or used products.
Products that are not sealed in original
"Tester", "Not for retail sale", or "Not
intended for resale" products and products labeled as "tester", "Not for retail
sale", or "Not intended for resale".
Products that do not have a required
Products that have been the subject of
recalls or safety alerts or warnings.
Products that have been the subject of
criminal enforcement, injunctions, or seizures.
Products or ingredients that are subject to
the MHLW or any or the other regulatory agencies warning letter.
Medical Devices, Accessories and other
products which Amazon does not allow to sell, such as:
Specially controlled medical devices,
specific maintenance management medical devices (e.g. pulse oximeters) and
highly controlled medical devices that are sold in FBA (Fulfillment by
Professional medical devices that are
advertised or sold to general customers without showing that are professional medical
Products that have been altered to change
the product's performance, safety specifications, or indications of use.
Products for which a premarket notification
is required but has not yet been filed.
Laser productsProducts that Amazon does not
allow to sell.
Other products that Amazon does not allow to sell.
Additional useful information
Pharmaceuticals and Medical Devices Agency: Medical Devices
Related Amazon help pages