On Feb 27th, China Food and Drug Administration (CFDA) published their inspection reports for eight international medical device manufacturers located in U.S., Europe, Japan, and Australia under its Medical Device Good Manufacturing Practice.
The FDA has ordered the recall of a mHealth app that helps people with diabetes determine how much insulin they should inject. The issue points to the continuing challenge of verifying the accuracy of digital health devices and drug dosage apps.
The US Food and Drug Administration (FDA) on Tuesday finalized a rule that requires medical device clinical investigations conducted outside the US to flexibly conform with good clinical practice (GCP) standards.
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