Module 14: Design Development and Certification of Medical Devices

17/11/2023

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

35

Global Transferability

Common Documents and Guidances • ISO standards, eg. 13485, 14971 • STED format • IMDRF guidances

Generally, the systems/procedures in place are similar across the regions STED may need tailoring to reflect comparative elements in the local market (eg. Similar products; ingredient regulations, etc.)

Masterclass Lecture 8

The Organisation for Professionals in Regulatory Affairs

36

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