Regulatory Updates

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US: Importing COVID-19 Diagnostic Test Kits

20 July 2020

Author: Reynaldo Roman | Senior Director, Regulatory Compliance COVID-19 diagnostic test kits and other in vitro diagnostic devices (IVDs) are...

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

9 July 2020

Author: Reynaldo Roman | Senior Director, Regulatory Compliance As of June 29, 2020, exporters of shipments to China, Russia, or...

Avoid Clinical Trial Disruption in South Africa

29 April 2020

Marken utilizes global network to reach patients throughout the world During this critical time, while countries like South Africa are...

US Importation of PPE

14 April 2020

Author: Reynaldo Roman | Director, Regulatory Compliance In an effort to facilitate the import and supply of PPE into the...

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

16 March 2020

Author: Nora Pasinetti Sauter In the light of the rapidly evolving situation of COVID 19 epidemic and recent reports from...

China: CFDA New Drug Import License Procedure

15 January 2020

Author: Reynaldo Roman China Food and Drug Administration’s new import licensing procedure requires importers to apply for their CFDA import...

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