The amendments are proposed to provide support for the medical devices inspection program and ensure a level playing field between foreign and domestic medical devices, and coverage with international guidance on mandatory problem reporting.
Les modifications proposées visent à appuyer le Programme d'inspection des instruments médicaux et à assurer l'uniformisation des exigences applicables aux instruments médicaux étrangers et nationaux, ainsi que le respect de directives internationales pour la déclaration obligatoire des incidents.