Country-Specific Medical Device Regulations

Marketing a medical device in a global environment offers many challenges, as regulatory requirements vary widely from one country to another.

Bringing a product to market in multiple countries requires understanding regional differences and knowing how to comply with all regulations.

NSF’s eLearning series of medical devices training courses covers country-specific requirements for Australia, Brazil, Canada, Japan and the United States. These on-demand, computer-based courses offer highly interactive instruction on each jurisdiction’s legal and regulatory framework, premarket pathways and requirements, and postmarket regulations. The courses also introduce the Medical Device Single Audit Program (MDSAP) and highlight specific country requirements that must be considered for MDSAP audits.