Module 14 2022

22/03/2022

• Regulators can AUDIT the STED at anytime, either by regular PLANNED audit, or, an UNANNOUNCED audit STED Life Cycle Maintenance

Masterclass Lecture 8

The Organisation for Professionals in Regulatory Affairs

33

Global Transferability Different Systems for Classification/Application

USA

Japan

• Pre-Market Notification 510K • PMA (Pre-Market Approval) EU • Class I Self-Certification • Notified Body Certification

• Pre-Market Submission (Notification) • Pre-Market Certification • Pre-Market Approval Some other IMDRF-aligned countries • As Japan

Masterclass Lecture 8

The Organisation for Professionals in Regulatory Affairs

34

17