Module 14 2022

22/03/2022

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.)

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The Organisation for Professionals in Regulatory Affairs

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If the device is part of a medicinal product

What if the device is part of a Drug Device Combination product following a medicinal product regulatory pathway.

How does the device information fit with the medicine file

Masterclass Lecture 8

The Organisation for Professionals in Regulatory Affairs

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