Announcement on Baby Thermometers Qualification Control

Dear AliExpress sellers,

To improve product quality and shopping experience on AliExpress, we have made the following rules for listing temperature measurement products in accordance with relevant laws and market regulations:

 

I. Product categorization

1. Baby thermometers (classified as medical devices) must be released under the category:

Mother & Kids>> Baby Care>> Baby Health Care>>Thermometers

2. Non-medical temperature measurement products (such as temperature measuring strips, pacifier thermometers, ear/forehead thermometer accessories) should be displayed under the following category:

Mother & Kids >> Baby Care>> Baby Health Care>> Baby Thermometers & Accessories (Non-medical)

The platform added this category on April 22, 2020.

3. Sellers should move their listed non-medical temperature measurement products to the corresponding categories from April 23, 2020 to May 20, 2020. AliExpress will start cracking down on categorization violations on May 20, 2020. If a product is found to have been improperly listed for the first time, the platform will take it down. In case of a repeated violation, the platform will delete the product. In case of a severe violation, the platform will delete the product even if it is the first violation.

 

II. Category qualifications and supplementary submission

1. Qualifications for baby thermometers (Thermometers):

(1) Permit for Medical Device Operation Enterprises, Recordation Certificate for Business Activities Involving Class II Medical Devices, or Medical Devices Manufacturing License (The applying entity must be the owner of the qualification document)

(2) Manufacturer's Permit for the Medical Device Production Enterprise

(3) Product packaging images (showing the manufacturer)

2. Qualification submission instructions

The platform plans to open the qualification submission portal for medical temperature measurement products on April 23, 2020. Please enter or upload the qualifications in time. The platform plans to verify sellers' qualifications on May 20, 2020. If either your qualifications are below standard or you have not provided any qualification documents, we will ban you from the thermometer category. Please check your store and submit the required qualifications in time.

If you fail to pass the qualification examination by May 20, 2020, you will be deprived of the permission to sell in the thermometer category. You can apply for the category permission and submit the required qualifications later. After the application is approved, you will be granted the permission again.

3. Path to submit qualifications: My AliExpress > Account and Certification > Applications > Category Qualifications. Please check the category and submit your qualifications.

 

III. Product listing standard

1. When listing baby thermometers:

(1) Sellers should enter or upload product qualifications. Such qualifications vary across markets:

·          Baby thermometers made in China must obtain a registration number for Class II devices from the China Food and Drug Administration (CFDA) (mandatory)

·          Baby thermometers sold to the EU require a CE certification (optional)

·          Baby thermometers sold to the US require FDA approval (optional)

(2) Sellers should put the following statement on the product detail page:

Please be kindly note:

-       Listed product is produced and distributed abroad and subject to the laws of its country of origin.

-       You may purchase the products for personal use only.

(3) FAQ about qualification submission: https://sell.aliexpress.com/__pc/LfHYeAD1WC.htm

2. The platform plans to open the qualification submission portal for medical thermometers on April 23, 2020. Please adjust the product category and enter or upload the qualifications in time. Please move the listed non-medical thermometers to the corresponding categories from April 23, 2020 to May 20, 2020. If you do not have permission for the medical thermometer category, please remove all relevant products.

3. Others

(1) It is forbidden to put ordinary thermometers and professional baby thermometers under the same URL and list them using the same SKU. The platform will intensify its efforts to punish such fraudulent listing.

(2) For more product listing rules, please see Announcement on Tightened Control of Epidemic Prevention Products on AliExpress

 

IV. Violations and punishments

1. If a product is found to have been improperly listed for the first time, the platform will take it down. In case of a repeated violation, the platform will delete the product. In case of a severe violation, the platform will delete the product even if it is the first violation.

2. If a product is found to have been listed under an incorrect category, the penalties are as follows: If the product is not listed under the specified baby thermometer category, the product will be taken down for further editing for the first violation and deleted for the second violation. In case of a severe violation, the product will be deleted even if it is the first violation.

3. If the product qualifications are fraudulent, the platform will mete out punishments to the store concerned, including but not limited to (i) returning the product or deleting the product information; (ii) restricting listing of the product; (iii) temporarily freezing the AliExpress/payment account; and (iv) closing the AliExpress account. For users whose AliExpress accounts are closed, AliExpress reserves the right to prevent the user from signing up for AliExpress again.

Reminder: Sellers are advised to check the product qualifications before listing to avoid punishments due to non-compliance. The relevant official databases that are open to public access include but are not limited to:

(1) List of notified bodies for CE marking:

https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notifiedbody.main,

Please ensure the bodies have the regulatory authority (see 93/42/EEC Medical devices and Regulation (EU) 2016/425 Personal protective equipment)

(2) FDA's database of listed devices: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm

(3) Registered Chinese medical devices:

http://qy1.sfda.gov.cn/datasearchcnda/face3/base.jsp?tableId=26&tableName=TABLE26&title=%B9%FA%B2%FA%C6%F7%D0%B5&bcId=118103058617027083838706701567

 

V. Miscellaneous

For instructions for delivery and performance assessment for epidemic prevention products, see (0331 Important Update) Announcement on Tightened Control of Epidemic Prevention Products on AliExpress.

Stores engaged in severe violations of the platform regulations will be penalized in accordance with the AliExpress Rules on Handling Severe Disruption of Platform Order:
Serious violation: 12 points/time, freezing the AliExpress account for seven days
Extremely Serious violation: 48 points/time, closing the AliExpress account

For more information about penalties for disrupting platform order, see the following rules:

Analysis of Search Cheating Cases and Penalty Rules

AliExpress Rules on Handling Severe Disruption of Platform Order

For AliExpress announcements on the epidemic, view Country-specific Sales Bans and Restrictions During the Pandemic (Constantly Updated).

 

Thank you for your understanding. AliExpress appreciates your continued support and trust amid the coronavirus outbreak.

 

 

AliExpress

April 22, 2020