Importing a first aid kit and personal protective equipment from China to the United States looks simple, well you should know that the procedure is not as easy as it looks and is not a viable option for every individual or companies.
When one decides to proceed there are some vital things the importer should look out for. This is to ensure that they do not run into problems with the federal government and regulatory authorities due to lack of knowledge.
Here are the tips to avoid problems for you to wholesale first aid kits from China.
Concern Patent Issue when wholesale first aid kits From China
Importing products from China is portable to save your budget but can be a risky thing to do if there is potential legal issue. When dealing with products or businesses with intellectual property rights, you have to trade with care and import products that are not covered by patents in the United States to avoid infringement.
A patent is when an inventor is granted the right to a property by a governing body or authority. This legal right granted to the inventor prevents other people from using, selling, or making that particular invention for a period of time.
The agency that handles the application and approval of patents in the United States is the U.S. Patent and Trademark Office (USPTO). The USPTO is a part of the Department of Commerce.
Generally, in the United States, most of the patents are valid for 20 years from the date of filing the application with the USPTO. The United States patents are valid only in the U.S. Territories and the United States.
FDA of the manufacturer when wholesale first aid kits
FDA is a Department of Health and Human Services’ federal agency that is saddled with the responsible for the promotion and protection of public health.
They regulate and supervise products, medical devices, infant formula, over-the-counter drugs, cosmetics, medical biologics, equipment, drugs for humans and animals, tobacco products and other products related.
If a product is FDA approved, it means that the FDA has ascertained that the benefits of using the product exceed the known risks.
If a product is FDA cleared it means the importer has shown that their product is identical to a similarly marketed device that has already been approved or cleared by the FDA known as a predicate.
Before you decide to wholesale the first aid kits from China suppliers, you need to double check the FDA and register number online, make sure the manufacturer's name is the one who sell to you to avoid customs issues. If the first aid kits are not FDA approved, the cargo would be forbidden to be sold to USA, you need to handle all fees to return back or destroy, this might cause you huge lose.
Classification of medical devices according to FDA
Medical devices are categorized into three classes by the FDA namely Class I, Class II, and Class III. Class III medical devices are devices that are implanted inside the body, or have the ability to sustain life, or can harm the body, and have the highest. They are also the only class of medical devices that requires FDA approval.
Class II and Class I medical devices are lower-risk devices that are used outside the body such as catheters, wheelchairs, etc., and they only require an FDA clearance.
Before any first aid kit can be imported to the United States from China, it is important that the FDA status of that product be known.
Another requirement of the FDA is that all medical products should have the name of the manufacturer on the packaging or label.
FDA of Buyer
The importers of wholesale first aid kits from China to the United States should be certified by the FDA. The importer should have an initial imports FDA number.
An initial importer is any importer who helps the marketing of a foreign manufacturers equipment to whoever finally sells the device to the end-user, but his initial importer does not repackage or alter the container, label, or wrapping of the device or its package.
As a manufacturer of first aid kits, we had some experience that our buyer didn't have FDA register number and the medical kits cannot be delivered him. If you do not have the FDA register number you need to tell the manufacturer in advance, some experienced manufacturer could offer solutions to avoid this problem before shipment.
Customs control
Custom control is a step-by-step process where an inspector checks, examines, and verifies the outgoing and incoming transport of goods, parcels, and or mails to ensure they are secure and meet the nation's laws and regulations.
This custom control is not exempted in the purchase of medical supplies from China and to the United States. If not managed well, custom control can turn out to be difficult to handle.
There is also payment of taxes and other fees which can be exhausting. To obtain this clearance from the CBP, importers of first aid kits must meet necessary steps of entry, examination, appraisal, classification, and liquidation.
Conclusion
Whether you’re a big company or organization importing a first aid kit in bulk quantities or a small business owner who is importing in small quantities or just a kit through the internet.
It is important that you ensure that this medical product being imported has not been patented in the United States. This will help avoid the trouble of patent infringement.
Checking for the FDA status of a medical product will help to know if the medical product has been certified by the FDA as a beneficial product to the public, and also to help keep the public safe while they make use of the medical product.
Also, it is important to know that your personal protective equipment have to pass through the Clearance and they should meet the necessary steps of entry, examination, appraisal, classifications, and liquidation.
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