News & Analysis as of

Country of Origin Medical Devices

Sheppard Mullin Richter & Hampton LLP

“Buy American” Update: FDA Issues List Of Essential Medicines Required By Executive Order

On October 30, 2020 the FDA published a list of essential medicines, medical countermeasures, and critical inputs as required by President Trump’s August 2020 Executive Order on Ensuring Essential Medicines, Medical...more

Hogan Lovells

To fight COVID-19, emergency Federal contracting tools streamline medical device, drug acquisition

Hogan Lovells on

Government needs are expanding rapidly and we expect they will continue to do so throughout this pandemic. Solicitations for products, services, and research and development efforts can be found at beta.SAM.gov using the...more

Hogan Lovells

"Make in India" Initiative Extends to Medical Devices - India's New Medical Device Rules Are Now in Effect

Hogan Lovells on

In January 2017, India's Ministry of Health and Family Welfare released the long-awaited Medical Device Rules of 2017 (MDR 2017 or the Act), which took effect on January 1, 2018. Upon implementation, this regulation replaced...more

Alston & Bird

OFAC Eases Restrictions on Medical and Agricultural Exports to Iran

Alston & Bird on

On December 23, 2016, the Treasury Department’s Office of Foreign Assets Control (OFAC) issued a final rule amending the Iranian Transactions and Sanctions Regulations (ITSR) to expand the scope of permissible exports and...more

Bass, Berry & Sims PLC

Happy New Year: OFAC Expands Exports of Medical Devices to Iran

Bass, Berry & Sims PLC on

Effective December 23, the Department of the Treasury’s Office of Foreign Assets Control (OFAC) amended the Iranian Transactions and Sanctions Regulations (ITSR) to expand the scope of medical devices that can be exported to...more

Morgan Lewis

Trade Agreements Act Compliance Activity Increasing at VA

Morgan Lewis on

Companies should include internal TAA compliance reviews in their overall manufacturing compliance programs. Every manufacturer of medical devices and pharmaceuticals that offers a product for sale to the federal...more

Morgan Lewis

Medical Device Manufacturer Settles Trade Agreements Act Suit

Morgan Lewis on

A whistleblower alleged that the manufacturer knowingly violated the Trade Agreements Act’s country of origin requirement. Government contractors must agree that the products they sell to the U.S. government under...more

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