Updated: Nov 9, 2021
First aid kits have been established as a great addition to everyone due to the role it plays in treating injured victims. However, for businesses interested in importing first aid kids into the United States, it is vital to have a good knowledge of the legal requirements before getting started. Read on to find out more about those legal requirements.
Do Research and Avoid Costly Patent Mistakes
This is one of the first steps to think of before anything else. When a product is patented, in this case, the first aid kit, it means that the property rights have been granted to the inventor of the product.
This prevents any other person from using, making, selling, or offering to sell the product in the country in which the patent was issued. Patents in the US are issued by the United States Patent and Trademark Office (USPTO). You can check the patent by this link.
The extent of the protection of the granted patent is contained in the claims of the patent. The terms of the patent claims make known to the public what is prohibited with the patent holder's permission.
The scope of the patent protection may vary from country to country as the patent office in each country or region examines the patent, and it may have different patentability requirements.
Patent infringement is when a third party uses, sells, or imports a patented product without the patent holder's authorisation.
In many countries, the term “use” is required to have a commercial purpose for it to be a patent infringement. The types of infringement include
Literal Infringement: This is when an act prohibited by the patent is being carried out.
Doctrine of Equivalents: This protects against creating a product that is the same basically, and by all rights with just a couple of modifications.
In countries like the US, there are two other types of infringements also
Contributory Infringement: This is when another entity participates in an infringement that is done by another.
Inducement to Infringement: This is when an entity assists another in violating a patent.
So, therefore, proper research must be done, and the terms of any patent discovered should also be properly understood to avoid costly mistakes.
2. Double Check if the Product and the Manufacturer are FDA Approved.
Here is a link to guide how to check FDA number
The Importer Should have Initial FDA Number
According to Title 21 Code of the Federal Regulations (21 CFR) Part 807.3(g), an initial importer is defined as an importer who promotes the marketing of a device from a foreign manufacturer to whoever makes the final sale or delivery to the consumer.
This importer, however, does not repackage or change the container, labeling of the device, wrapper, or device package. The regulatory requirements a medical device initial importer is required to comply with include
Medical Device Reporting (MDR).
Corrections and Removals Reports.
Medical Device Tracking where applicable
3. The Label
The label of the first aid kit that is being imported into the US is another thing that needs to be checked. The label should have “MADE IN CHINA” printed on it. It should also have the manufacturer’s name printed on it too.
When you choose to import first aid kits from a Chinese manufacturer, you should check out this legal information. It is also advisable that you choose a partner with experience in exporting products to the US. This would help you avoid some problems because they would be familiar with some of the processes and requirements you might miss.