Brazil ANVISA Shares Update on IVD Regulation RDC 830/2023
Emergo by UL reports from Hospitalar 2024 on updates to new legislation for IVD devices in Brazil
New Zealand to Repeal Therapeutic Products Act 2023
The New Zealand Associate Minister of Health announced the government’s intent to repeal the Therapeutic Products Act 2023, which otherwise would come into force this year.
Updated European Commission Data Dashboard
The EC has updated the medical device availability dashboard announced in early 2024.
Mexico’s Ministry of Health Makes Progress with SaMD
The regulator in Mexico, COFEPRIS, released a 5.0 edition of the Supplement of Medical Devices of the Mexican Pharmacopoeia (hereafter: Pharmacopoeia), which inserted regulatory requirements for Software as a Medical Device (SaMD).
RAMS® e-Learning
Enhance your regulatory knowledge with our e-learning training modules designed to meet your needs and exceed your expectations.
Brazil ANVISA Legislation Allows Leveraging Regulatory Authorizations for Medical Devices
Brazilian medical device regulator ANVISA has published new legislation allowing manufacturers of higher-risk devices to leverage registrations from some foreign regulatory authorities when applying for market access in Brazil.
Dutch Regulators Issue Report on AR Compliance with MDR, IVDR
A recent IGJ inspection report finds that one-third of European Authorized Representatives in the Netherlands have yet to fully follow MDR and IVDR requirements.
Developing a Strong Justification to Forgo Human Factors Validation Testing
Emergo by UL human factors specialists share tips for building a strong justification for forgoing HF validation testing.
Understanding User Realities: How Ethnographic Research Benefits Medical Device Development
Emergo by UL user research and human factors specialists share tips for using ethnographic research to augment human factors activities throughout medical device development.
Transform Informal Human Factors Work into Submission-Worthy Content
Emergo by UL human factors specialists share ways manufacturers can “take credit” for informal HF work by transforming it into submission-worthy content.