Dear Sellers of Alibaba.com
As the pandemic remains a major factor, and in light of different countries/regions’ laws, regulations and regulatory requirements regarding Medical Devices, as well as its intention to maintain a healthy and sustainable trade environment Alibaba.com is reaffirming that, in addition to the existing platform policies regarding listing medical devices and the existing criteria for medical devices, Alibaba.com requires the compliance with the requirements of any applicable destination countries to list products on for sale into those markets.
For example, a medical device can be legally sold to the U.S., only when it is cleared by the U.S. Food and Drug Administration (FDA) and fully compliant with the applicable laws, regulations and regulatory requirements of the U.S. Sellers are reminded to keep themselves abreast of the latest compliance requirements of all applicable destination countries for their products and comply with such requirements accordingly.
Sellers are further reminded that any listing and trading on Alibaba.com must be fully compliant with the applicable laws of destination countries and platform rules. The seller must identify the correct classification of medical devices and list them under the appropriate categories on the platform, and the product details that the listing contains must be totally factual and accurate. Alibaba.com will monitor sellers’ listing and trading behavior. In the event of any violations, including but not limited to provision of any fraudulent product qualification, falsifying qualification documentation or the lack of the required qualification documentation, Alibaba.com may, subject to the seriousness of relevant violation, impose a range of penalties against the relevant seller, including but not limited to removal of product listings, deletion of products, deduction of points, restricted access to Alibaba.com, termination of the seller’s account, and/or restricted sale of any or all products to certain countries.
Alibaba.com will continue to monitor the changes in laws and related policies of countries worldwide, and adjust our platform rules accordingly. Please contact our online customer service for any further queries.
Thank you for your support and attention.
Please refer to《Details of Reaffirmation of the Requirement to Comply with Legal and Regulatory of Destination Countries against the Sales of Medical Devices》for more details
What kind of products are required to meet the compliance requirements of the destination countries?
All products that are defined as medical devices, either domestically or according to the laws and regulations of the destination countries, must meet the legal and regulatory requirements of the destination countries.
2. If I want to sell medical devices to another country, what compliance requirements should be met by Seller?
In additional to meet the current rules and requirements for selling medical devices on Alibaba.com, Sellers must also comply with compliance requirements of destination countries for selling medical devices. However, different countries have their own legal and regulatory requirements on medical devices. Sellers are reminded to keep themselves abreast of the latest compliance requirements of all applicable destination countries for their products and comply with such requirements accordingly. All the compliance requirements provided in this document are for reference only.
For example, if seller wants to sell medical devices to the U.S. market, in addition to meet the current rules for selling medical devices on Alibaba.com, the following qualifications must be obtained as well:
(a) All medical devices must be registered on FDA (Establishment Registration & Device Listing) before selling to the U.S. market.
(b) Certain Class I and Class III medical devices and most Class II medical devices require an extra 510(k) premarket notification cleared by FDA.
(c) Most Class III medical devices and certain Class II medical devices require an extra PMA premarket approval authorized by FDA.
For more information about the definition, categorization, classification, and the qualification requirements of medical devices regulated by FDA, please refer to FAQ 10 in this document.
3. How do I upload the required licenses and certifications of destination countries?
Please login in the account and upload the relevant documents via below path from your Home page. Please fill in all mandatory sections correctly and faithfully.
Home >Verified Supplier Center > Certification Upload
In Type section, select: Country Restricted Sales Access
In Product Category section, select: Compliance Requirement of Destination Countries for Medical Device
In Certificate Name section, select the one that fits your situation
In Scope section, please fill in the type of the product. E.g., Contact Lens, Ventilators
4. How to verify the seller’s and/or the product’s qualification?
If a Seller declares that he/her has obtained valid certifications (in images or texts), such as the qualifications authorized by CE institutions in EU, FDA or National Institute for Occupational Safety and Health certification (NIOSH) of the U.S. and etc., please refer to FAQ 3 and upload the documents. The products listing on Alibaba.com must be included within the scope of the qualification obtained by the Seller. Otherwise, the Seller must edit the product details and resubmit valid qualification documents.
To check whether a manufacturer is certified by China Chamber of Commerce for Import & Export of Medicines & Health Products (CCCMHPIE), click here.
To check whether medical device manufacturers are registered with FDA, and/or medical devices are listed with FDA, click here.
To check whether a medical device is cleared by FDA 510(k) premarket notification, click here.
To check whether a medical device have obtained the premarket approval (PMA) by FDA, click here.
To query the mask models approved by NIOSH, click here.
5. How to deal with Trade Assurance orders that in transit?
If all products in the placed order meet the compliance requirements of the domestic and the destination countries’, please fulfilled the order as promised.
If any of the product in the order fails to meet the compliance requirements of either the domestic’s or the destination countries’, and the orders have not been shipped, we recommend that you negotiate with the buyers for cancellation of the orders. If it fails to cancel the order, the refund/dispute risks arising from non-compliance with qualification requirements shall be taken by the seller
6. Do I have to list all necessary information of a medical device product?
Yes, please provide all relevant and necessary information of the medical device faithfully and correctly. It is vital to provide the correct product name, medical device classification, its function, as well as label.
Why my medical devices still can’t be sold to the destination country even they meet the compliance requirements of the destination countries’?
Remember that only when medical devices meet the compliance requirements both at home and abroad., then they can be legally sold to the destination country. So please check and make sure that you can meet all the requirements.
8. My products meet the current platform rules for selling medical devices on Alibaba.com, as well as the compliance requirements of the destination country. Why do I still be punished by the platform?
Alibaba.com will monitor and inspects product listings and/or orders for quality control. In the event of any violations, Alibaba will impose different penalties against the relevant seller subject to the seriousness of relevant violation
Violation scenarios include but are not limited to the following:
① The product description contains forbidden and/or improper information in text or pictures, or other forms of inappropriate information,
② the key information of the product is incorrectly described. For more information, see FAQ #6.
③ provision of any fraudulent product qualification, or falsifying qualification , deceitful or exaggerate marketing, and/or other dishonest behaviors;
④ publish of non-compliant information via instant communication, RFQ, live broadcasting, repeated violation of platform rules;
⑤ publicly reprimanded by regulator, exposed by mainstream media that causes harmful effect of the platform;
⑥ and/or other violations identified by the platform after careful evaluation.
9. How do I determine if the product would be considered as a medical device in China? If so, how do I identify the classification of the medical device?
Method 1: You can check and identify the categories as well as the classification of medical devices in China on the website below: Category Catalog of Domestic Medical Devices.
Method 2: You can also query the product on the website of National Medical Products Administration of China (NMPA).
Step 1. Open the NMPA website. On the page that appears, click Domestic Devices.
Step 2:the Data Query page, click Domestic Devices (Historical Data).
Step 3. Enter the product name in Chinese, such as nitrile gloves, in the search bar and click Search.
Step 4. If there is any search result returned, the product is categorized as a medical device in China.
As indicated in red box below, a serial number starting with 1 indicates a Class I medical device, 2 indicates Class II, and 3 indicates Class III.
10. How do I determine if the product would be considered as a medical device in the destination country? If so, how do I identify the classification of the medical device?
Sellers are reminded to keep themselves abreast of the latest compliance requirements of all applicable destination country for their products and comply with such requirements accordingly.
For example, if you want to sell a product to the U.S. market, please visit the Product Classification website of the U.S. Food and Drug Administration (FDA)to query information following the below steps.
Step 1: On the Product Classification page, enter the product name on the Device section and then search, e.g., gloves.
Step 2. If the returned results match the primary categories of the product, such as examination “gloves” or “surgical gloves”, the product is categorized as a medical device in the U.S.
As framed in red box in the following figure: Device Class of 1, 2, 3 indicates Class I, II, III medical device, respectively.
If it turns out “Not Classified” or “Unclassified” in the Device Class column, the class of the device does not have a definition yet, by default setting, these products are automatically considered to be Class III as suggested by the FDA.
. What can I do if I need further help?
1）Contact your account manager.
2）Contact the customer service by telephone: 400-826-1688.
Any updates of the control measures will be announced in advance. Please pay attention to the announcement released on the rules channelpage of Alibaba.com and email notices.
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