Public docket for comments – USFDA Proposes to End Temporary Extension of GUDID’s Grace Period
Posts published in “Day: December 19, 2018”
Survey regarding where members of Team-nB are in the MDR designation process – Team-NB is publishing a survey on the MDR designation process present stages in…
Manufacturers with CE Marking shall update their procedures and forms. Fabricantes com Marcação CE devem atualizar seus procedimentos e formulários. Manufacturer Incident Report (MIR) for Serious…
Here: NB-Med and Team-NB have jointly edited a white paper entitled “White Paper – One Year of Application”
A new program focusing on “to encourage innovation and market entry of device technologies that are safer than current alternatives”. Read here: Statement from FDA Commissioner…
Interesting framework to evaluate the performance of regulators – Regulator Performance Framework: Self-assessment Report, July 2017 to June 2018. Framework interessante para avaliar o desempenho deTGA…
Here – Breakthrough Devices Program; Guidance for Industry and Food and Drug Administration Staff