Regulatory Constraints for Medical Products Using Biomaterials

Abstract Medical products using biomaterials are subject to controls by regulatory agencies around the globe and despite earnest efforts to harmonize these regulations often reflect the specific cultural experiences with medical devices. Not only do the regulations for market entry vary, but countries do not even agree on what constitutes a reportable adverse event. Quality systems requirements are similar, but not identical, despite efforts to create a unified system of inspections for multi-national companies. The common regulatory controls are: 1) registration/listing or licensing, 2) premarket approval, 3) reporting adverse events, but beyond those similar barriers the methods of controls are highly differentiated.