Shipping medical supplies to the US has become the Wild West. There is an international scramble for face masks and other protective equipment used by medical professionals. Hospitals that used to buy from contract companies are working directly with suppliers or brokers to meet their needs. Some traders are brand new to the playing field, having to negotiate customs laws and ever-changing trade policies. With a strained supply chain and high demand, one misstep can result in damaging delays.
Know the laws, policies and regulations of shipping medical supplies
Importing and exporting policies are changing rapidly during this unprecedented time. That can create confusion and missed opportunities. On March 5, 2020, the Trump administration lifted tariffs on the import of Chinese-made medical face masks to ease procurement. In another dramatic move, the FDA approved the use of KN95 masks (the Chinese-version of the N95 masks). After several instances of questionable products being returned, China recently implemented new measures to insure quality control on coronavirus related exports. While some policy changes have eased trade, others have created additional delays and left millions of face masks and protective gowns stuck in warehouses or ports waiting to be shipped.
With so much focus on China, it is important to know that other countries are producing much needed coronavirus-related medical supplies. India, Vietnam and Mexico are all sources manufacturing face masks, protective gowns, hospital beds and ventilators needed to be imported to the US. Each country has its own policies, laws and regulations that an importer needs to be aware of in order to avoid delays and roadblocks.
Know your medical device classification code
Medical supplies manufactured in foreign countries are subject to additional regulations, because the US does not recognize regulatory approval from other countries. The FDA will have to ensure that your products meet the safety and effectiveness standards before they can be released. That is why it is important to make sure you have your products properly classified before shipping.
Class I: General Controls
Class I devices are not intended to support life, prolong life and do not present an unreasonable risk of illness or injury. For most Class I medical devices, the US just requires the labeling meets FDA requirements. Examples of Class I medical devices include gloves, protective surgical gowns and hand-held surgical instruments.
Class II: General Control with Special Control
These devices carry a greater risk of causing injury or illness. They need to comply with the general controls and also with the special controls. The special controls can include labeling requirements, performance standards and postmarket surveillance. Postmarketing Surveillance or PMS, monitors the product’s performance after it has been released into the market. Examples of Class II medical devices include motorized wheelchairs, surgical drapes, infusion pumps, N95 or KN95 masks, and ventilators.
Class III: General Controls, Special Controls, and Premarket Approval
Medical devices fall under this category if they are used to prolong or support human life, are important in preventing harm to human health, or present a possible and unnecessary risk of illness or injury. Products can also fall under this category if there is not enough documentation presented that assures safety and usefulness. For these reasons, these medical devices must go through premarket approval, receive scientific overview and meet all of the general controls of Class I products. Examples of devices that fall under class III are implantable pacemakers, external defibrillators, and COVID-19 diagnostic tests.
Shipping Medical Supplies to the USA
High demand for medical supplies means that these orders need to ship quickly. This has been a real challenge for already overstretched logistics companies. Air freight has been impacted the most with the cancellation of many passenger flights. While charter carriers may still accept bookings, deliveries may face substantial delays and cost a premium to ship. Ocean freight is also available, but some carriers are running on modified routes due to the coronavirus pandemic. This may result in delays in delivering desperately needed medical supplies. For these reasons, shipping medical supplies through a well-established logistics company with long-standing relationships and a vast network is ideal so your cargo can be delivered as quickly as possible.
MACH 1 GLOBAL SERVICES CAN HELP YOU SHIP Medical Supplies to the US
With over 30 years of experience, Mach 1 Global is a freight forwarder that specializes in shipping medical supplies to and from the US. With long established logistics networks, our chartered air freight and ocean freight services will help transport your cargo reach its destination quickly. To learn more about how we serve the medical industry, visit our website to view case studies and our transportation services. To discuss how Mach 1 Global can assist you call (800) 553-7774 or get a quote by clicking HERE.
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