Public docket for comments – USFDA Proposes to End Temporary Extension of GUDID’s Grace Period
Posts published by “Marcelo Antunes”
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
Comments on both the Therapeutic Products Bill and the Therapeutic Products Regulatory Scheme: Consultation document.
REPORT ON NON-DEVICE SOFTWARE FUNCTIONS: IMPACT TO HEALTH AND BEST PRACTICES – DECEMBER 2018
Manufacturing Site Change Supplements: Content and Submission; Guidance for Industry and Food and Drug Administration Staff; Availability https://www.federalregister.gov/documents/2018/12/17/2018-27237/manufacturing-site-change-supplements-content-and-submission-guidance-for-industry-and-food-and-drug