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March 5, 2019

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…

February 26, 2019

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)…

February 20, 2019

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…

February 12, 2019

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…

February 5, 2019

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…