Regulatory Updates

Additional Sanctions Against Russia and Belarus

1 June 2023

Author: Reynaldo Roman, Sr. Director Regulatory Compliance The Bureau of Industry and Security (BIS) has implemented additional sanctions against Russia...

Marken Regulatory Update: New U.S. Customs Postal Code Requirement

7 February 2023

Author:  – Reynaldo Roman, Senior Director, Regulatory Compliance As of March 18th, 2023, importers of goods from China to the...

New Import Control System 2 (ICS2) requirements for shipments entering or transiting the European Union

17 January 2023

Updated on 31 January, 2023 Author: Anna Cesar – Manager, Regulatory Compliance EMEA Effective March 1, 2023, Economic Operators will...

UK Consultation on Proposals for Legislative Changes for Clinical Trials

12 May 2022

Author: Anna Cesar – Manager, Regulatory Compliance EMEA The United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has ran,...

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...