This is the third installment in our series regarding Mexico’s medical device regulator COFEPRIS announcement of its revised draft labeling standard.
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The U.S. FDA published the text of the Final Rule for Laboratory Developed Tests (LDTs) May 6.
In this on-demand webinar, our Emergo by UL subject matter expert shares insights on how to navigate revised IVD regulation RDC 830/2023.
Here we describe our top pre-market consideration takeaways from the MedCon Conference in Columbus, Ohio on April 24-26 for those who were unable to attend.
The medical device regulator in Mexico, COFEPRIS, recently released a new project for the NOM for Medical Device labeling, NOM-137-SSA1-2024 that is open for industry comment.
This update summarizes Brazil's medical device regulatory activity for the first months of 2024.
Medical device makers who want to access the Hong Kong market must comply with the latest regulatory requirements in this special administrative region of China.
In this on-demand webinar, our Emergo by UL’s expert shares insights on how to navigate the Singapore HSA-Thai FDA Reliance Program for Medical Devices.
This is the first in a series of regulatory updates on the labeling standard for medical devices, IVDs and pharmaceuticals in Mexico.