Brazil Market Update: Amendments to RDC No. 751/2022 on Medical Device Registration and Notification
Brazil’s national health surveillance agency, ANVISA has published RDC No. 777/2023.
European Update: Is an EU MDR Article 59 Derogation a Way to Continue to Market?
Is an EU MDR Article 59 Derogation a Way to Continue to Market?
Chinese Regulators Publish Timelines for Medical Device Supplementary Information and 2022 Medical Device Standards
Chinese Regulators Publish Timelines for Medical Device Supplementary Information and 2022 Medical Device Standards Management Report
Expectations for Post-Market Surveillance (PMS) in the European MDR
What’s the status of your EU MDR Article 86 Periodic Safety Update Report (PSUR)? Class IIa legacy devices are approaching the deadline of their first PSUR, whereas Class III and IIb legacy devices should already have their first PSUR issued.
Medical Device and IVD Registration and Approval in Hong Kong
Emergo by UL can support you by gaining regulatory approval to sell medical devices and IVDs in the Hong Kong Market. This includes full support with the compilation of the registration dossier and acting as your representative.
Brazil Update: Does RDC 751/2022 Change Labeling Requirements?
A look at what has changed between RDC 185/2001 and RDC 751/2022 in terms of medical device labeling requirements
Overview of New Brazilian Regulation RDC 751/2022
In this Emergo by UL webinar, our subject matter expert outlines the latest updates to the new Brazil regulation.
Brazil Update: Does RDC 751/2022 Simplify the Grouping of Devices?
Brazil update: Does RDC 751/2022 simplify the grouping of devices?
Brazil’s New RDC 751/2022 and the Technical Dossier Regulatory Submission
Effective March 1, 2023, the technical dossier must be structured as described in Brazilian medical device regulation RDC 751/2022.
European Commission Proposal for Amending MDR, IVDR Makes Progress
The European Council has published a proposal for amending (EU) 2017/745 and (EU) 2017/746.