Global Considerations

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MDR Implementation Delay Recommendations

In light of the COVID-19 pandemic, AdvaMed supports postponing the implementation of the In Vitro Diagnostics and Medical Devices Regulations until the situation has stabilized and all healthcare stakeholders can again dedicate the resources needed to properly implement the Regulations in a manageable way.

April 17, 2020 | EU MDR delay clears Parliament, enters final stages
*April 8, 2020 | MDR Amendment – Proposal for a Regulation of the European Parliament and of the Council amending Regulation (EU) 2017/745 on medical devices as regards the dates of application of certain of its provision
March 25, 2020 | MedTech Europe Statement on the European Commission’s proposal for a delay in MDR implementation
March 25, 2020 | European Commission spokesman Stefan De Keersmaecker shares in a Q&A that the European Commission is working on a proposal to postpone MDR implementation for one year and intends to submit the proposal in early April.
March 23, 2020 | MedTech Europe Press Release: “MedTech Europe calls for a pause on IVDR and MDR implementation to facilitate the fight against COVID-19 and to safeguard Healthcare Systems”
March 20, 2020 | MedTech Europe: “Mitigating the Impact of COVID-19 on Healthcare Systems – Urgent Need to Pause the new Medical Technology Regulations Implementation”

AdvaMed Staff Contact: Joe Gatewood

Other Trade Issues

March 25, 2020 | Global Medical Technology Alliance: Open letter to the G-20 Heads of State and Government: Need to collaborate to open global trade in response to COVID-19
March 20, 2020 | Comments on Section 301 Tariffs on COVID-19 Related Products USTR: Response to Coronavirus Crisis – Invites Public Comments to Identify Additional Products Potentially Helpful to U.S. Response”

AdvaMed Staff Contact: Ralph Ives

Country-Specific Resources

India

April 6, 2020 | Invest India’s Business Immunity Platform Report business continuity issues; connect with the government of India on COVID-19 solutions; get the latest government notifications related to the shutdown and efforts to fight COVID-19.

AdvaMed Staff Contact: Abby Pratt

How Foreign Manufacturers of COVID-19 Products with FDA Approval Can Get on China’s Export White List

*May 11, 2020 | Export Declaration Of Medical Supplies
*May 11, 2020 | China’s Process For Allowing The Export Of COVID-19 Products Without NMPA Approval
*May 11, 2020 | Chinese Government’s Evaluation Process Of Manufacturers’ Standards And Qualifications For Relevant Epidemic Prevention Products

AdvaMed Staff Contact: Veronica McBride

Additional Global Resources

May 27, 2022 | COVID-19 Global Weekly Update
May 20, 2022 | COVID-19 Global Weekly Update
May 13, 2022 | COVID-19 Global Weekly Update
May 6, 2022 | COVID- 19 Global Weekly Update
April 29, 2022 | COVID- 19 Global Weekly Update
April 22, 2022 | COVID- 19 Global Weekly Update
April 8, 2022 | COVID- 19 Global Weekly Update
April 1, 2022 | COVID- 19 Global Weekly Update
March 25, 2022 | COVID- 19 Global Weekly Update
March 18, 2022 | COVID- 19 Global Weekly Update
March 11, 2022 | COVID-19 Global Weekly Update
March 4, 2020 | COVID-19 Global Weekly Update
February 25, 2022 | COVD-19 Global Weekly Update
February 18, 2022 | COVD-19 Global Weekly Update
February 11, 2022 | COVD-19 Global Weekly Update
February 4, 2022 | COVD-19 Global Weekly Update
January 28, 2022 | COVID-19 Global Weekly Update
January 21, 2022 | COVID-19 Global Weekly Update
January 14, 2022 | COVID-19 Global Weekly Update
January 7, 2022 | COVID-19 Global Weekly Update
December 17, 2021 | COVID-19 Global Weekly Update
December 13, 2021 | COVID-19 Global Weekly Update
December 10, 2021 | COVID-19 Global Weekly Update
December 3, 2021 | COVID-19 Global Weekly Update
November 19, 2021 | COVID-19 Global Weekly Update
November 12, 2021 | COVID-19 Global Weekly Update
November 5, 2021 | COVID-19 Global Weekly Update
October 29, 2021 | COVID-19 Global Weekly Update
October 22, 2021 | COVID-19 Global Weekly Update
October 15, 2021 | COVID-19 Global Weekly Update
October 8, 2021 | COVID-19 Global Weekly Update
October 1, 2021 | COVID-19 Global Weekly Update
September 24, 2021 | COVID-19 Global Weekly Update
September 17, 2021 | COVID-19 Global Weekly Update
September 10, 2021 | COVID-19 Global Weekly Update
September 3, 2021 | COVID-19 Global Weekly Update