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  • Latin America
  • MedTech

Mexico COFEPRIS Announces Revised Draft Labeling Standard

This is the third installment in our series regarding Mexico’s medical device regulator COFEPRIS announcement of its revised draft labeling standard.

RAPS Convergence 2024

Schedule a meeting to learn more about how we can support you in getting to market faster.

U.S. FDA Final Rule Published on Laboratory Developed Tests (LDTs)

The U.S. FDA published the text of the Final Rule for Laboratory Developed Tests (LDTs) May 6.



Revised IVD Regulation RDC 830/2023

In this on-demand webinar, our Emergo by UL subject matter expert shares insights on how to navigate revised IVD regulation RDC 830/2023.

  • Global
  • MedTech

2024 MedCon Takeaways: Pre-Market Considerations

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.

  • North America
  • MedTech

Mexico COFEPRIS Announces Revised Draft Labeling Standard

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.

  • Latin America
  • MedTech

A Busy Few Months for Brazil ANVISA

This update summarizes Brazil's medical device regulatory activity for the first months of 2024.

  • Asia Pacific
  • MedTech

Hong Kong Regulatory Updates: Additional Leveraged Country Authorizations and a Digital Platform

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.

Singapore HSA-Thai FDA Reliance Program for Medical Devices

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.

  • Latin America
  • MedTech

Mexico COFEPRIS Announces Revised Labeling Standard

This is the first in a series of regulatory updates on the labeling standard for medical devices, IVDs and pharmaceuticals in Mexico.