Regulatory Updates

The Latest

Canada New Client Portal

AUTHOR: Anna Cesar | Regulatory Compliance Associate The Canada Border Services Agency (CBSA) is modernizing and streamlining the process of importing commercial goods. The CBSA Assessment Revenue Management (CARM) solution will give importers and brokers 24/7 acces...

  • Canada New Client Portal

    AUTHOR: Anna Cesar | Regulatory Compliance Associate The Canada Border Services Agency (CBSA) is modernizing and streamlining the process of importing commercial goods. The CBSA Assessment Revenue Management (CARM) solution will give importers and brokers 24/7 access to border services through the new CBSA Assessment Revenue Management Client Portal (CCP). Canada’s importers and customs brokers… Read more »

  • The New European Medical Device (MDR) and In-Vitro Regulation (IVDR)

    AUTHOR: Anna Cesar | Associate, Regulatory Compliance The transition period for the new European Medical Device (MDR) and In-Vitro Regulation (IVDR) will end soon – May 26, 2021, and May 26, 2022, respectively. If you are an importer of medical devices or IVDs to the EU, you must be prepared for changes. Importer role under… Read more »

  • India: New Mandatory Pre-Arrival Clearance Procedures

    AUTHOR: Reynaldo Roman | Senior Director, Regulatory Compliance India’s Central Board of Indirect Taxes and Customs announces a new rule requiring all air cargo arriving in India to be Customs cleared no later than the day of arrival and preferably before arrival. As of April 1st, importers must ensure that their shipment documents are complete,… Read more »

  • India: New Mandatory Document Requirements

     merchandise for import into the country. On Jan 14th, 2021, India’s Central Board of Indirect Taxes and Customs published Advisory No: 02/2021 announcing a new rule requiring Customs brokers to submit certain documents to Customs when clearing merchandise for import into the country. The new rule requires mandatory uploading of product-specific documents in the e-Sanchit… Read more »

  • New EU Mandatory Export Authorization for COVID 19 Vaccines

    The European Commission announced last week a new, mandatory export authorization requirement for COVID-19 vaccines covered by an Advance Purchase Agreement (APA) with the EU. The new rule applies to vaccines against SARS-related coronaviruses (SARS-CoV species) falling under CN code 3002 20 10 and cover active substances including master and working cell banks used for… Read more »

  • US: Importing COVID-19 Diagnostic Test Kits

    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 »

  • US: New Export Filing Requirement for Shipments to China, Russia or Venezuela

    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 »

  • AVOID CLINICAL TRIAL DISRUPTION IN SOUTH AFRICA

    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 »

  • US Importation of PPE

    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 »

  • Coronavirus COVID-19 and Dangerous Goods handling / Transportation F.A.Q.

    AUTHOR: Nora Pasinetti Sauter In the light of the rapidly evolving situation of COVID 19 epidemic and recent reports from the WHO (World Health Organization), US CDC (Center for Diseases Control & Prevention), ECDC (European Center for Diseases Prevention & Control), Marken has developed the following FAQ.   What is the Dangerous Goods Classification for… Read more »

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