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Many importers are surprised when they learn about all the rules and regulations that come with importing sunglasses and glasses into the U.S. Before embarking on this challenging process, it’s important to have a full understanding of what will be required.
Key Takeaways
In this article, we provide a detailed breakdown of the specific requirements for importing sunglasses and glasses into the United States.
Surprising to some, reading glasses are classified as a Class 1 medical device by the FDA (Food and Drug Administration). This means they must comply with certain federal regulations. You need to understand how this affects the overall importing process.
It’s usually not necessary to file a pre-market notification application for Class 1 devices or get FDA clearance ahead of time. However, you will need to register your business annually with the FDA in order to be able to import reading glasses.
There are a few parameters that reading glasses will need to fulfil in order to be categorized as Class 1 medical devices. For instance, they need to have impact resistant lenses, as well as being made of materials that are non-flammable and non-toxic.
The FDA also has jurisdiction over non-prescription sunglasses, and this means they are categorized as a Class 1 medical device as well. Much like reading glasses, there is no need to submit data or product examples for FDA approval on non-prescription sunglasses. However, you must register with the agency to import these goods.
Companies manufacturing and/or distributing these medical devices will also need to file for medical device listing. This process is generally done online using FURLS, the FDA’s Electronic Registration and Listing System. This requirement applies to all parties involved in the manufacturing, distribution, or importation of sunglasses. The FDA uses this information in the event of a product defect or issue.
Hearing that a product doesn’t require FDA approval provides a false sense of ease and simplicity regarding the import process. Even without the need for prior approval, there are still many FDA rules with which sunglasses must comply.
The process for importing products that are regulated by the FDA certainly comes with many challenges. To learn more, check out our article on FDA Customs Clearance.
Proper documentation is an essential element of any import process. Failure to include all required documents is likely to cause major issues during importing, including:
Our article “What Documents Do I Need to Import and Export?” covers general import documentation requirements in detail. However, there is additional paperwork associated with importing medical devices.
Our Expert Customs Consultants Will Personally Guide You.
You may also find that you’re going to need paperwork and documentation that shows your products adhere to FDA requirements. For example, the FDA’s Quality System (QS) requirements set forth in 21 CFR 820, as well as 21 CFR 801.410 state that there must be impact resistant lenses in eyeglasses and sunglasses.
Impact resistance is a significant aspect of product safety when it comes to eyewear. To measure impact resistance, the FDA requires certain results from a drop ball test.
The drop ball test consists of the following steps.
For the purposes of the test, “fracture” is defined as the lens breaking throughout its entire thickness.
Every shipment of glasses must be accompanied by a statement indicating that the lenses have passed the drop ball test.
If you’re importing for the first time, you’ll need to complete another form. CBP Form 5106 is known as the Import Identity Form and must be completed by first-time importers in order to register with CBP.
Your success in shipping and importing as a business depends largely on your products’ country of origin.
For instance, the strained trade relations between the United States and China led to the introduction of Section 301 tariffs in 2018. These apply additional fees to products being imported from China into the United States.
This means that if you are planning on shipping sunglasses and eyeglasses from China, you’ll end up paying more than standard duties. Additionally, your shipment will likely face increased scrutiny because it’s coming from China.
Thankfully, while China does export a significant amount of sunglasses to the United States, there is an even more popular option.
Related: How to Import Camping Gear
In 2022, Italy exported over $3 billion worth of sunglasses, outpacing China by hundreds of millions of dollars. The United States imports more Italian goods than any trade partner outside the European Union, so many of those shades found their way stateside.
Even if you find a Chinese supplier with a lower price, you may find that sourcing from Italian vendors is ultimately a better option once you factor in the tariffs on Chinese products. You’re also more likely to clear customs quickly with goods sourced outside of China.
The general rates of duty for imported sunglasses or glasses to the USA are listed in the table below.
As noted earlier, sunglasses or glasses from China may be subject to additional import duties under Section 301 tariffs. Partnering with a customs broker is the best way to accurately calculate the total duties and tariffs you’ll owe on shipments from China.
From fashionable shades to practical corrective lenses, demand for eyeglasses of all kinds is consistent in the U.S. For importers to benefit from this demand, they need to make sure their imported goods meet all pertinent FDA standards. If you’re not sure how to make that determination, we can help.
When you partner with USA Customs Clearance, you’re putting years of experience importing eyeglasses and other medical devices to work for you. We know what it takes to ensure that these goods are compliant with strict FDA rules and regulations.
Our services include:
Give us a call at (855) 912-0406 or fill out a contact form online. We’re ready to help you see your way to successfully importing eyeglasses.
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