Importing a first aid kit and personal protective equipment ppe 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.
However, 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.
This article provides an overview of the concerns involved in the importation of first aid kits From China to the United States.
Concerns when importing personal protective equipment From China to the United States.
Patent Issue
Importing products into the United States is great but can be a risky thing to do. 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.
In exchange for the patent rights, there must be a patent application provided to the public that unveils the invention in adequate detail for a person with ordinary art skills to be able to practice or make the invention.
Simply put a patent is the granting of a property right by a sovereign authority to an inventor. It provides the inventor with rights to the patented process, design or product 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.
According to the USPTO, a person can only be given a patent if the person “Invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent, subject to the conditions of the requirements of the law.”
Types of patent
In the United States and other countries, there are different types of patents. They include:
Utility Patents
Also known as patents of invention, a utility patent is a legal protection given to inventors of new processes, useful products, machines, and chemicals.
Over 90% of the patents issued by the U.S. government are utility patents making it the most common patent. If the maintenance fees are constantly renewed, a utility patent runs for 20 years from the date of filling and as long as fees for maintenance are paid.
Design Patents
These patents are granted to protect the unique look or design of a manufactured product, new designs or originals.
The innovation that has the design must be useful and authentic. Design patents filed after May 13, 2015, last for 15 years while those filed before May 13, 2015, last for 14 years.
Plant Patents
This patent is granted to anyone who invents, discovers, or asexually produces a new and unique kind of plant with the ability to reproduce.
This patent lasts for 20 years from the date it is filed, and it doesn’t have maintenance fees. patents protect the properties of companies to help their profitability and also improves their worth.
If an already patented first aid kit is sold in the United States, it will lead to a major problem.
Food and Drug Administration, FDA of the manufacturer
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.
Clinical testing results and a premarket approval must be submitted by the manufactures to get the approval. The FDA will likely approve a product with a high risk if the possible benefit is significant.
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.
A 510(k) or a premarket notification submission must be submitted to the FDA by the companies for a product review before clearance and then to be sold in the U.S.
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 medical products 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.
There must be a physical address in the country tied to the initial importer, and this address must also have employees that are to ensure that the imported devices all meet the laws and regulations of the FDA.
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 frustrating and 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.
A percentage is applied to the value of the imported kits; this can be dutiable per piece, per pound or per kilogram.
Border Protection
They ensures that all pharmaceuticals imports are legitimate and can go through the border without being seized or being fined. They have tools for inspecting products based on the ECCN classification list.
If they finds any suspicious imports which hasn't been authorized by FDA, then they will seize it immediately even if you try to explain that your product is for a personal purpose, such as first aid kits.
Generally, they also have the authority to fine anyone who tried to import prohibited goods into the border beyond their control, such as seized goods exceeding $500 in retail value.
Long waiting time
Times are better now and with the advancement in technology life has been made easier and better. Still, receiving a purchase of a first aid kit from China can take longer than expected.
This delay occurs because the package might take some time to be shipped from the factory, state and then finally the country.
Additionally, rom the moment the products leave the factory until they arrive in the hands of an individual or company can take longer than two weeks to months depending on the method of shipments.
This means that when importing a first aid kit from China it is important you consider the shipping method. Some of these methods include:
1. Air freight
The airfreight method is the most efficient method and fastest method of importing your first aid kit from China. This method of imports promises fast delivery and is usually used for items that weigh less. It is mostly used by importers who are involved with time-sensitive products.
This method is reliable and safe but just like everything that has a benefit it also has a limitation. The air freight method is expensive and its rate is determined by the weight and the volume of your first aid kit.
Although this helps reduce the long waiting time of importation by delivering in hours, you might have to consider your budget before deciding on this method.
2 Express Freight
The second method is the Express Freight, which is also efficient for a short notice first aid kit purchase. It is only cost effective when you are shipping in small quantities.
For larger purchases it is recommended that you use the air or ocean freight. The Express Freight method is carried out by one company, examples of these companies include UPS, DHL, FesEx.
3. Ocean Freight
The last recommended method for your first aid kit is the Ocean Freight, which is the most commonly used shipment method by many importers.
If you own a first aid kit company and you are purchasing in large bulk this is the best method of choice for you to use. Also, this method is the most cost-effective eco-friendly method.
However it is important that you know that this method takes a long time to deliver your products because the process is carried out slowly and takes time to process.
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 of great importance 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.
Before placing your orders make sure you are able to see through these minor problems and ensure a convenient shipment method for your first aid kits.
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.