EU Medical Devices Nomenclature is now available
The European Commission has recently made available the latest advancements on the Medical Device nomenclature under the new European Regulations on Medical Devices. To meet MDR and IVDR requirements, the Commission is required to make available…
ANVISA launches Cumprimento Eletrônico de Exigência electronic system
ANVISA has officially launched Cumprimento Eletrônico de Exigência system in the currently available Sistema de Peticionamento Eletrônico on February 26th. Códigos de assunto for petições secundárias, such as alterações (modifications), revalidações (renewals), aditamentos (suplements), cancelamentos (cancellations)…
Therapeutic Goods Administration (TGA) updates Application procedure for Export Certificate and Certificate of Free Sale for Medical Devices
Australian Therapeutic Goods Administration (TGA) has recently updated the Application procedure for Certificate of Free Sale and Export Certificate for Medical Devices. Certificates of Free Sale and Export Certificates are documents supplied by the Australian Authorities…
New EU Medical Devices and IVDs portal to ease transition to Medical Devices Regulations
The Medical Devices section on the European Commission’s website has been restructured to help smooth the transition to the new Medical Devices and IVDs regulations. The new website explains the main differences between the current Directives…
ANVISA implements Cumprimento Eletrônico de Exigência electronic system
ANVISA has recently implemented Cumprimento Eletrônico de Exigência system in the currently available Sistema de Peticionamento Eletrônico. Cumprimento Eletrônico de Exigência is intended for regulatory inquiry management during the review process of Medical Device submissions. Once…
