We are medical device import experts
The FDA has established classifications for approximately 1,700 different types of devices, divided into three regulatory classes, depending on the intended use of the device and its indications for use.
Your current customs broker may not specialize in medical devices. You need the expertise of WB Skinner to ensure that your medical device products arrive safely and on time.
WB Skinner can help you to:
- Determine the appropriate class for your products,
- Understand the regulations and latest FDA bulletins, and
- Execute your import procedures quickly and without additional hassles
Medical devices include a wide range of products from pacemakers, medical lasers and diagnostic xray systems, to contact lenses, hearing aids, dental floss and thermometers! Imported medical devices must fully comply with the Federal Food, Drug and Cosmetic Act, before the devices are imported into the U.S.
Medical device shipments have certain codes that need to be put into the entry forms. Many customs broker agents simply are not as familiar with these codes and procedures as Skinner, which has been in business for over half a century with a specialty in medical device shipments. Although the FDA doesn’t require these codes, your shipment can be stopped and delayed due to FDA document requests.
Skinner helps you to anticipate any possible delay or additional request, and ensures that your shipment moves through government bureacracy quickly and without delay.