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This article applies to selling in: Japan

Guidelines for Selling Medical Devices (for Marketplace Merchants)

Many stores at Amazon Services carry a wide variety of medical devices, including contact lenses, blood pressure gages, massagers, adhesive bandages and medical gauze. However, with regard to the number of products, there are special restrictions and obligations regarding the sale and storage of medical devices based on the Japan Pharmaceutical Act, requiring separate management from that of general merchandise.

This document describes the details of the classes of medical devices being sold on Amazon Services and the required information and procedures for their registration. If Amazon Services determines that a product does not comply with these guidelines, the product in question will be removed without notice.

Sellable medical devices

As a basic rule, all classes of medical devices are sellable on the Amazon Marketplace. Because the fulfillment center does not have an office manager provisioned by the Japan Pharmaceutical Act for Fulfillment by Amazon (FBA) products, medical devices that require designation of an administrator (specially controlled or highly controlled medical devices) are not sellable.

Table 1. Medical Device Classes

Medical Device Class Class Name Marketplace FBA Notes
III/IV

Items that require appropriate management due to the high risk to human life or health in the event of an adverse reaction or malfunction

Highly controlled medical devices Yes No Contact lenses
II

Items that require appropriate management due to the risk to human life or health in the event of an adverse reaction or malfunction

Specially controlled medical devices

(Designation of an administrator is required)

Yes No Electronic blood pressure gages, infrared thermometers, low-frequency therapy devices, hearing aids
Controlled medical devices

(Administrator designation or notification not required)

Yes Yes Electronic thermometers, condoms, home-use massagers, home-use magnetic therapy devices (Pip Elekiban, etc.)
I

Items that do not normally pose a risk to human life or health in the event of an adverse reaction or malfunction

General medical devices Yes Yes Adhesive bandages, medical gauze

Specially maintained medical devices

Medical devices that require specialized knowledge or techniques for their management, such as regular inspection or repair, may not be sold in FBA regardless of the above classes.

Professional medical devices

Medical devices provided for use by a healthcare worker, such as professional medical devices, are sellable in Marketplace and FBA with browsing restrictions using a reader confirmation screen as shown below due to the restriction of general consumer advertisements. Prior to sale, confirm with the manufacturer whether the product is a professional medical device.

Screen to confirm browsing of professional medical devices (subject to change)

Starting sale of medical devices

Confirm the following information with the manufacturer in advance:

  • Name of marketing authorization holder
  • General name of medical device
  • Medical device class (general, controlled, specially controlled, highly controlled)
  • Corresponding medical device number (notification number, authorization number or confirmation number)
  • Whether the device is a professional medical device
  • Whether the device is a specially maintained medical device (if so, sale is prohibited)

In addition, you may be required to submit an attached document (or instruction manual) and photocopy of product package showing statutory labeling when listing controlled, specially controlled or highly controlled medical devices. Please prepare of them if applicable.

To sell highly controlled medical devices, such as contact lenses, you may be required to submit a copy of your highly controlled medical device seller's license. Prepare this in advance.

Listing general and controlled medical device products

After you register your medical device products, Amazon.co.jp may request you to submit the documents below via e-mail. If you receives the request, you need to submit the following 3 types of documents to cops-jp-umcc-seller@amazon.co.jp.

  1. Medical Device Information Sheet

    Click here to download.

  2. Attached medical device document

    Documents defined with Pharmaceuticals and Medical Devices Law (See Appendix. 4)

  3. Photocopy of product package showing statutory labeling (See Appendix. 5)

You need to input the following information into 1. Medical Device Information Sheet.

Entry Item Description
Medical device class Select the corresponding medical device class
  • General medical device
  • Controlled medical device
Medical device number. (notification number, authorization number or confirmation number) Enter the corresponding medical device number in alphanumeric Example: 15B3X00014000001
Professional medical devices Indicate whether the device is a professional medical device
Maintenance of the professional repair factory Indicate whether the device needs the maintenance of the professional repair factory

The entry item and available medical device class vary depending on the store to which the product is being added. (See Appendix 3).

When adding a single product that includes multiple medical devices, such as a first aid kit, register the information for the product with the largest medical device class.

If submission of the documents cannot be confirmed or the attached documents are inconsistent with the product, the product deemed sellable by Amazon Services may not be listed or may be deleted.

Confirming whether a product is sellable

Amazon Services cannot reply to questions regarding the above medical device information.

Contact the manufacturer directly.

Examples of questions: "To which medical class does my product belong?" "Is this product a professional product?"

Catalog description

The following descriptions are not allowed in the catalog:

  • Descriptions that deviate from the attached medical device document and descriptions that exaggerate the effects and efficacy confirmed in the attached document. For example: Cures incurable diseases.
  • Descriptions that suggest a medical device or medical practice for a product that is not a medical device. For example: Use of the expression "thermometer" for a product that is not a medical device or is an unauthorized product.

In addition to the above circumstances, if the description is deemed inappropriate in light of applicable laws and terms of use may be edited without notice.

Request from Amazon Services

Request to submit information regarding medical device

If the information about a medical device product that is listed or is to be listed is insufficient, Amazon Services may request that the information be edited or additional information be provided. If no response is received within two weeks of the request, the product deemed sellable by Amazon Services may be deleted without notice.

Date Revised Revision Notes
2016/10/6 New publication

2016/10/31 Added and modified rules Version A

Appendix 1. List of Medical Devices Sellable on FBA

The following medical devices can be sold by the Amazon fulfillment center of Amazon.co.jp.

List of Sellable Medical Devices

Class Name Number General Name
Controlled medical devices

(Administrator designation not required)

1609 Dental adhesives
1610 Glue-type denture adhesives
1611 Liner-type denture adhesives
1718 Electric massagers for home use
1719 Pneumatic massagers for home use
1720 Vacuum-powered massagers for home use
1721 Vibrators with attached needles
1722 Heated acupressure massagers for home use
1723 Acupressure massagers with rollers for home use
1724 Pneumatic acupressure massagers for home use
1725 Ultrasonic bubble massage baths for home us
1726 Bubble massage baths for home use
1727 Whirlpool massage baths for home use
1728 Bathtubs for hydro massage therapy for home use
1757 Electromagnetic induction therapy apparatus for home use
1758 Magnetic induction therapy apparatus using permanent magnets for home use
1760 Moxibustion apparatus
1761 Ultrasonic vaporizers for home use
1762 Electric humidifiers for home use
1763 Electric vaporizers for home use
1764 Batch process water de-ionizers
1765 Continuous flow water de-ionizers
1780 Adhesive bandages
1781 Acupuncture equipment for home use
1782 Vaginal douches
1783 Contraceptive micro-condoms
Controlled medical devices

(Notification not required)

160 Electronic thermometers
1784 Female contraceptive condoms
1785 Male contraceptive condoms
General medical devices Aneroid-type blood pressure gages, hand dynamometers, oral cleaning instruments, nasal washing instruments, alcohol disinfectant, elastic stockings, eyeglasses, colored lenses, eyeglass lenses, eyesight test chart, electrodes for low-frequency therapy devices for home use, electrodes for potential therapy devices for home use, emergency adhesive bandages

Appendix 2. Examples of Medical Devices

Sellable medical devices (general and controlled medical devices)

The following are examples of past products. List the product after confirming the correct medical device class with the manufacturer.

Electronic thermometers: Electric massagers: Adhesive bandages: Condoms: Medical gauze: Reading glasses:

Medical devices prohibited on FBA (specially controlled and highly controlled medical devices)

The following are examples of past products. List the product after confirming the correct medical device class with the manufacturer.

Infrared thermometers: Contact lenses: Hearing aids: Pulse oximeters: Blood pressure gages: Low-frequency therapy devices:

Appendix 3. Stores That Can Sell Medical Devices

The medical device classes of sellable products vary depending on the store.

Y: Sellable

N: Not sellable

*: Contact us in advance

Store General medical devices Controlled medical devices Specially controlled medical devices Highly controlled medical devices
Office Products Y (reading glasses) Y N N
Musical Instruments N N N N
Home Y (reading glasses) Y (first aid kits) N N
Kitchen Y (adhesive bandages) Y (massagers) * (electronic blood pressure gages) N
Electronics and Cell Phones N N N N
Cameras Y (reading glasses) N N N
Computers N N N N
Major Appliances Y Y (large massagers) N N
Toys N N N N
Sporting Goods Y (medical gauze) Y (massagers) N N
Household Products and Repair Products Y (reading glasses) Y N N
Business, Industrial and Scientific Supplies Y (exam gloves) Y N N
Auto Parts Y Y (chairs with magnets) N N
Pets N N N N
Baby & Maternity Y (adhesive bandages) Y (thermometers) * (aspirators) N
Beauty Y (adhesive bandages) Y (massagers) N N
Health & Personal Care Y (adhesive bandages) Y (massagers) * * (contact lenses)
Food & Drink N N N N
Apparel Y (clothing with magnets) N N N
Shoes Y (shoes with magnets) N N N
Luggage & Bags N N N N
Watches N N N N
Jewelry N N N N
Books N N N N
DVDs N N N N
Music N N N N
Software N N N N
Video Games N N N N

Appendix4. Attached medical device document


Photocopy of product package showing statutory labeling


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