Mexican Regulator COFEPRIS Revises Equivalency Route to Expand Leveraging Options
To evaluate health supply registrations, Mexico’s COFEPRIS released a new agreement for the equivalency requirements established by the Health Supplies Regulations.
UK Medical Device Regulators Remove Revocation Dates for Assimilated EU Laws
Our regulatory experts update you on the MHRA publishing the UK Statutory Instrument No. 591, which is intended to remove the revocation dates of four pieces of assimilated EU law.
Search Functions in the European Medical Device Database EUDAMED
As a sequel to our recent update on searches that can be performed in the U.S. FDA 510(k) database, Emergo by UL reports on medical device searches in the European database for medical devices, EUDAMED, with the device registration data that has already voluntarily been included.
FDA Expands 510(k) Premarket Notification Database to Include New Sub-Categories to Enhance Search Capabilities
The FDA has added six new subcategories to make it easier for users of the 510(k) Premarket Notification Database to search for cleared medical devices.
MHRA Publishes Guidance on Updated Schema for Incident and FSCA Reports in MORE
Great Britain’s medical device regulator unveiled new guidance outlining the implementation of new manufacturer incident (MIR) and field safety corrective action (FSCA) report XML schema definitions (XSD) for Great Britain for the Manufacturer’s Online Reporting Environment (MORE) reporting system.
AI Literacy Per the European AI Act
As medical device manufacturers increasingly integrate AI technologies, the responsibility to confirm staff and end users possess adequate AI literacy is no longer optional. Understand what you need to know about AI literacy laws.
Swissmedic Releases New Guidance and Adopts the Updated EU MIR Form
Our regulatory experts bring you up to speed on the European Commission release of a new help text file with information for completing the Manufacturer Incident Report (MIR) form.
FDA Expands Unannounced Inspections at Foreign Manufacturing Plants Beyond India and China Pilot
The Office of Inspections and Investigations (OII), part of the U.S. FDA, will expand its program pilot of unannounced inspections beyond India and China.
European Commission Releases New Manufacturer Incident Report Form and Help Text
Read our regulatory experts’ timely summary of this latest medical device regulatory development from the European Commission
Switzerland Continues Efforts to Recognize Non-European Regulatory Authorizations
The Swiss Federal Assembly voted to approve Motion 20.3211, which mandated the Swiss Federal Council to adopt regulations to allow medical devices authorized by non-European regulators to enter the Swiss market.