Jaw implant manufacturers are apparently the latest segment of the medical device industry to experience the new get-tough stance by US regulators. The three major manufacturers of temporomandibula
Canada’s Office of the Auditor General has found Health Canada’s medical device surveillance and inspection processes unsatisfactory, according to The Montreal Gazette.
New draft guidance from the US Food and Drug Administration recommends compliance pathways for medical device manufacturers regarding
Canadian medical device market regulator Health Canada will begin requiring manufacturers and importers to send Mandatory Problem Reports (MPRs) to its Health Canada Vigilance-Medical Device Progra
New draft guidance from the US Food and Drug Administration recommends improvements to medical device manufacturers’ clinical study designs in order to better assess safety and effectiveness of their products according to gender.
A new report commissioned by the US Food and Drug Administration recommends a seven-year, multi-step implementation project in order to establish a nationwide postmarket surveillance system for medical devices.
Ein neuer, von der US Food and Drug Administration in Auftrag gegebener Bericht empfiehlt einen siebenjährigen Umsetzungsplan mit mehreren Stufen für ein nationales Überwachungssystem für Medizinprodukte nach der Markteinführung.