AUTHOR: Reynaldo Roman | Senior Director, Regulatory Compliance COVID-19 diagnostic test kits and other in vitro diagnostic devices (IVDs) are FDA-regulated products that require FDA and Customs and Border Protection (CBP) clearance when imported into the US. The FDA regulates imported medical devices and IVDs. Generally, imported devices must have FDA marketing approval or must… Read more »

AUTHOR: Reynaldo Roman | Senior Director, Regulatory Compliance As of June 29, 2020, exporters of shipments to China, Russia, or Venezuela must comply with a new, mandatory export filing requirement. Any export shipment from the United States to China, Russia, or Venezuela, involving an item classified under an Export Control Classification Number (ECCN), requires an… Read more »

MARKEN UTILIZES GLOBAL NETWORK TO REACH PATIENTS THROUGHOUT THE WORLD During this critical time, while countries like South Africa are extremely limited with transport options, Marken utilizes our global network to safely transport biological sample shipments out of the country and ship clinical drug products to sites and patients. Our fully operational status ensures we… Read more »

AUTHOR: Reynaldo Roman | Director, Regulatory Compliance In an effort to facilitate the import and supply of PPE into the US, both Customs (CBP) and the FDA have provided guidance on the types of PPE that may be imported. To combat PPE shortages, the FDA has invoked its Emergency Use Authorization (EUA) authority to lift… Read more »

As of July 1, 2018, imports into Australia of clinical trial kits containing placebos or a combination of medicines and placebos are duty-free. A recent update to the Australian Customs Tariff introduced new “Free” rate of duty provisions for clinical trial kits and placebos under Schedule 4, item 56. The kits and placebos covered under the new… Read more »