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...
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23/07/2021
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 »
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25/05/2021
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 »
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30/03/2021
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 »
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08/02/2021
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 »
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01/02/2021
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 »
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20/07/2020
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 »
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09/07/2020
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 »
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29/04/2020
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 »
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14/04/2020
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 »
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06/03/2020
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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