Regulatory Updates

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CDC Noninfectious Certification Statement

20 April 2022

Recently the Centers for Disease Control (CDC) reminded the trade community that shipments of noninfectious diagnostic specimens must be accompanied...

FDA Launches New 24/7 Drug Entry Review Pilot

24 March 2022

Author: Anna Cesar – Manager, Regulatory Compliance EMEA From March 13, 2022, through June 13, 2022, the Food and Drug...

Canada New Client Portal

23 July 2021

Author: Anna Cesar | Regulatory Compliance Associate The Canada Border Services Agency (CBSA) is modernizing and streamlining the process of...

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

25 May 2021

Author: Anna Cesar | Associate, Regulatory Compliance The transition period for the new European Medical Device (MDR) and In-Vitro Regulation...

India: New Mandatory Pre-Arrival Clearance Procedures

30 March 2021

Author: Reynaldo Roman | Senior Director, Regulatory Compliance India’s Central Board of Indirect Taxes and Customs announces a new rule...

India: New Mandatory Document Requirements

8 February 2021

On Jan 14th, 2021, India’s Central Board of Indirect Taxes and Customs published Advisory No: 02/2021 announcing a new rule...

New EU Mandatory Export Authorization for COVID 19 Vaccines

1 February 2021

The European Commission announced last week a new, mandatory export authorization requirement for COVID-19 vaccines covered by an Advance Purchase...

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...

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