Announcement on the Tightened Control of Medical Device Products on AliExpress

Dear sellers,

To improve the overall quality of products sold on AliExpress and optimize the shopping experience, the platform will strengthen control over the qualifications and access of medical device products in two batches. The specific categories and batch control time are as follows:

The first batch of 20 subcategories (the qualification submission portal will open on March 25, 2020):

The second batch of 23 subcategories (the qualification submission portal will open on April 1, 2020):

1. Product categorization

Class II and Class III medical device products must be released under the relevant medical device subcategories listed above under Beauty and Health.

2. Product listing

When listing a medical device product, the seller must enter its origin and enter or upload the corresponding product qualification information according to the target market, as follows:

·          Medical masks made in China must obtain a registration number for Class II/III devices from the China Food and Drug Administration (CFDA) (mandatory)

·          Medical devices sold to the EU require a CE certification (optional, but mandatory for contact lens-related categories)

·          Medical devices sold to the US require FDA approval (optional)

·          Medical masks sold to Japan require PSE certification (optional)

·          Medical masks sold to South Korea require KC certification (optional)

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

The platform plans to open the qualification submission portal for all categories under mandatory control on March 25, 2020 and enforce the qualification rules from April 15, 2020 (the portal for medical mask products has been opened; the qualification rules have been enforced since March 12, 2020). The second batch of categories will be put under mandatory control from May 15, 2020. Please adjust the product category and enter or upload the qualifications in time. In addition, the EU CE marking for contact lenses, color contact lenses and contact lens care solutions is required. Without the certification, the products will be prohibited from selling in the EU market.

3. Violations and penalties

The platform will regularly check medical device products:

a) 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.

b) 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 medical device category, the product will be taken down for further editing for the first violation and deleted for the second violation.

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

Thank you for your attention and support.
 

AliExpress

March 22, 2020