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Medical device classification is the first major step in the regulatory process, whether you’re aiming to sell in the United…
On September 25, 2024, the FDA published a proposed change to the classification rules for several…
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued an updated guidance for notifying clinical investigations involving medical…
The MDCG 2021-4 rev.1 document, updated in September 2024, offers essential guidance on Class D IVD Certification,…
Using any type of product in a manner not intended by its manufacturer has the potential to cause harm, a…
The European Union has introduced new standards to enhance the safety and quality of substances of human origin (SoHO), such…
Swissmedic informed Swiss Authorized Representatives and Regulatory Importers of their expectations regarding follow-up on the transitional provisions and obligations related…
As the September 26, 2024, deadline for MDR Conformity Assessment Agreements rapidly approaches, medical device manufacturers are reminded of the…
The International Medical Device Regulators Forum (IMDRF) has today published its latest IMDRF Document Implementation Report. This…
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