Manufacturers, Regulatory Requirements, Registration Requirement

UK Government consults stakeholders on changes to UK REACH

Mayer Brown on 5/29/2024

On 16 May 2024, the UK Government launched an open consultation seeking stakeholders' views on various government proposals and policy options aimed at facilitating the transition of companies from EU REACH to UK REACH, and...more

FDA Publishes Draft Guidance For Submitting Cosmetic Product Facility Registrations and Product Listings Under MoCRA

Perkins Coie on 8/22/2023

The U.S. Food and Drug Administration (FDA) issued draft guidance on August 7, 2023, clarifying new requirements for cosmetic facility registrations and product listings under the Modernization of Cosmetics Regulation Act of...more

State Registration Enforcement

Gardner Law on 7/20/2023

Are you licensed to sell in these states? Most U.S. states require manufacturers to register, and gain a state-issued licensure, to sell or manufacture products within state boundaries. In fact, the following states...more

Overview of Medical Device Regulation in China

Morgan Lewis on 3/2/2020

How is the manufacturing, marketing, distribution, and sale of medical devices regulated in the People’s Republic of China? This article outlines the regulatory framework and pathways, the classification of devices, and...more

Publication of further guidance on the role of the “UK Responsible Person” in case of no-deal Brexit

Hogan Lovells on 10/1/2019

On 18 September 2019, the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) published new guidance regarding the role and responsibilities of the “UK Responsible Person”. ...more

Arizona Requires Registration of Contract Manufacturers

Stinson LLP on 3/4/2019

Like many states, Arizona requires that a non-resident manufacturer of prescription medical devices that sells or distributes its devices in Arizona, obtain a permit from the Arizona Board of Pharmacy. Arizona defines...more