The eCommerce and medical device markets are each currently growing at a rapid rate, so naturally many business owners are merging the two and seeing great results. In October 2019, the FDA reported overseeing more than 6,500 different medical device product categories, with about 35 percent of medical devices used in the United States being imports.

With that said, FDA compliance is a huge priority for medical device brands, and many are turning to 3PL service providers to help them fulfill their product orders. Before we get into the reasons to outsource your medical device fulfillment, let’s review what it means to be an FDA-registered fulfillment center:

What is an FDA-registered fulfillment center?

The Food and Drug Administration (FDA) is an agency within the U.S. Department of Health and Human Services whose objective is to protect the public health by ensuring the safety, effectiveness, and security of products intended for human use. These products can include, but are not limited to:

  • Medical devices
  • Food and beverage products
  • Vitamins
  • Medicine
  • Dietary supplements

Companies that ship products intended for human use are required by law to register with the FDA, or partner with a fulfillment services provider that is. FDA-registered fulfillment centers follow specific guidelines and are routinely inspected to maintain the safety of the products that are handled there.

Here at Global Response, we are proud to share that our fulfillment center is now FDA-registered to fulfill medical devices. In addition to having the ability to import and distribute health, beauty and dietary products, we can also handle the packing, inventory control, and shipping on medical devices.

Why should I outsource medical device fulfillment?

If you’re weighing your options on whether to go the self-fulfillment route versus partnering with a leading 3PL services provider for your medical device fulfillment, consider these three reasons to outsource:

  • FDA-registered medical device fulfillment centers know how to work with specific products.
  • You’re probably not a fulfillment expert, but the team at an FDA-registered fulfillment center is.
  • Failing to operate an FDA-registered warehouse can have serious consequences.

Now let’s dive a little deeper into each of these reasons to outsource medical device fulfillment.

FDA-registered medical device fulfillment centers know how to work with specific products.

When outsourcing your medical device fulfillment to an FDA-registered 3PL provider, you can rest assured that the facilities are clean and well-equipped to handle a variety of products.

You’re probably not a fulfillment expert, but the team at an FDA-registered fulfillment center is.

As an entrepreneur or business manager, your expertise is likely not in fulfillment. In addition to everything else that’s on your plate, do you really want to take the time to become a fulfillment expert? When your partner with a leading 3PL company, you can focus on other tasks while knowing with confidence that your orders are being properly fulfilled by a team of experts.

Failing to operate an FDA-registered warehouse can have serious consequences.

If your business ships medical devices and you choose to go the self-fulfillment route, you are required by law to register your warehouse or fulfillment center with the FDA. The failure to register with the FDA and follow its regulations can result in costly fines of up to $500,000, as well as the suspension of your business license.

If this sounds like more than you wish to take on as a business owner, outsourcing your medical device fulfillment to a 3PL services provider is probably the best option. A leading fulfillment services company is experienced in shipping medical device businesses, and can ensure that all guidelines are followed to keep your products in top-notch shape.