Starting from May 17th, products like those sold on AliExpress that do not comply with Canadian regulations for export will not be allowed to be displayed or sold in the market

Starting May 17th, non-compliant products cannot be sold on AliExpress in Canada

In order to cope with the current global increase in demand for exported goods, improve the overall product quality of AliExpress, ensure that products meet local compliance requirements in Canada, and protect consumer safety and shopping experience, AliExpress will strengthen control over the sale of medical device products and merchants to Canada.

Scope of Control

As defined in Part 2 of the Canadian Food and Drugs Act, Canadian medical devices refer to any instrument or component used to treat, diagnose, or prevent diseases or abnormal physical conditions, excluding any equipment related to animals.

Medical devices can be used for:

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• Diagnosis, treatment, relief or prevention of diseases, disorders, abnormal physical conditions or corresponding symptoms;

• Restoration, alteration or correction of body structure or function;

• Diagnosis of pregnancy or prevention of pregnancy;

• Care for pregnancy, childbirth and postpartum personnel.

The scope of medical devices ranges from bandages, toothbrushes and contact lenses to complex devices such as X-ray machines, insulin pumps and pacemakers. In addition, it includes diagnostic equipment such as cancer screening tests, blood glucose monitors, and pregnancy test kits.

Based on the risk to human health and safety, Health Canada classifies medical devices into four categories: Class I, II, III, and IV; Class I medical devices (such as thermometers) have the lowest risk to human beings, while Class IV medical devices (such as pacemakers) have the highest risk.

Health Canada’s guidelines on classification can be found here. Health Canada has also issued a keyword index to assist in classification, which can be found here. The index lists multiple categories of medical devices for reference.

Control Measures

Health Canada issues the following two certificates for medical devices:

• Medical Device License (MDL) – a license issued by Health Canada for Class II, III, and IV medical devices [alibabal1] for the product itself. • Medical Device Establishment License (MDEL) – a license issued by Health Canada to authorize entities engaged in activities related to Class I, II, III, and IV medical devices, including but not limited to manufacturing, importing, distributing, and selling. Alibaba platform does not allow the sale of Class III or IV medical devices. To sell Class I or II medical devices, sellers need to hold a Medical Device License (MDL) and/or a Medical Device Establishment License (MDEL) issued by Health Canada. Health Canada maintains a searchable MDL database and MDEL database. • If the manufacturer or brand seller sells medical devices to the end consumer: to sell Class I medical devices, the seller should hold an MDEL; to sell Class II medical devices, the seller should have the corresponding MDL for the product. • If the non-manufacturer or brand seller sells medical devices: to sell Class I medical devices, the seller should hold an MDEL (the manufacturer must be listed in the MDEL), to sell Class II medical devices, the seller should submit the corresponding MDL in addition to the MDEL. All sellers exporting medical devices to Canada must hold relevant qualification documents issued by Health Canada. Please complete the necessary preparations for Canadian compliance as a seller, and ensure that your products are listed in the correct category to ensure smooth trade with Canada.

Attention: Under Canadian law, manufacturers refer to entities that sell medical devices under their own name or under the name of entities in which they have controlling interest.

For businesses that possess the aforementioned admission materials, please contact the platform’s industry category responsible person for admission application.

Controlled Time

This announcement’s control measures will be executed on May 17, 2023. From May 17, 2023 (Beijing time), non-compliant products will not be allowed to be displayed or sold in the Canadian market.

Violation and Punishment

The following are the penalties for violations after control begins execution:

1. If a product has not submitted or has not passed the platform’s Canadian qualification review, the platform will block the related product from the Canadian market.

2. If the uploaded qualification materials are seriously inconsistent with the product, the platform will treat it as a false certificate and delete the product and deduct 6 points/time.

3. If the product is not released in the correct category, the platform will take down the product for the first violation (editable);

For the second violation, the platform will delete the product; for repeated violations, the platform will increase the punishment to deleting the product and deducting 2 points/time.

For accounts with serious violations, the platform will execute the following punishments based on the “Global AliExpress” serious disruption of platform order rules:

Malicious evasion: Delete and deduct 6 points/time serious: 12 points/time (account frozen for 7 days) particularly serious: 48 points/time (account closed)

The platform reminds businesses to comply with product compliance laws applicable in their own country and the destination country. For members who maliciously bypass rules, publish non-compliant information in any scenario (such as communication, live streaming, etc.), repeatedly violate rules, are notified by regulatory authorities, exposed by important media, and have other serious violations, the platform will take measures including but not limited to deleting product information, deducting points, blocking the store, restricting the use of website product functions, freezing accounts, and closing accounts in accordance with relevant rules.

If you still have pending orders, it is recommended that the merchant proactively contact the buyer to cancel the order. We will continue to monitor policy changes in various countries and make corresponding adjustments to platform control policies accordingly.

Reference materials:

Regulations for exporting medical devices to Canada: zllp.myyxxx_:ini?_okgyu=sce?a02irkynd0=3nynf29=gh # .

Food and Drugs Act of Canada: zllp.myydrx.adk=._ui.l=o?_co_ory?scyrol.yFa27y=sv?j_zlgd

Medical Device Regulations of Canada: zllp.myydrx.adk=._ui.l=o?_co_ory?scyw?cidrl=ks.ySORa98a282y

Confirmation of medical device classification in Canada: Guidance for Industry- Keyword Index to Assist Manufacturers in Verifying the Class of Medical Devices

Guidance Document – Guidance on the Risk-based Classification System for Non-In Vitro Diagnostic Devices (non-IVDDs)

Note: The above information is for reference only and does not guarantee completeness, accuracy, or timeliness. AliExpress reserves the right to modify and supplement this content.

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